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Merck & Co Inc. (NYSE:MRK)

Suvorexant Phase III Data

June 13, 2012 2:00 pm ET

Executives

Carol Ferguson

Darryle Schoepp - Senior Vice President and Head of Franchise

Joseph Herring

Darryle Schoepp - Former Senior Vice President and Director of Neuroscience Drugs

Denise Williams

Analysts

Seamus Fernandez - Leerink Swann LLC, Research Division

Jessica Fye - JP Morgan Chase & Co, Research Division

Alison Yang - Barclays Capital, Research Division

Derek Yuan - UBS Investment Bank, Research Division

Carol Ferguson

Hi, everybody. Good afternoon. Welcome to those who could join us firsthand, in person in Boston. We appreciate you coming to be with us live. And we're welcoming to those who are on our webcast. I am Carol Ferguson with Merck Investor Relations, and with me today are a couple of my colleagues from Merck Research Labs. I have Dr. Darryle Schoepp, who is Head of Merck Research and Development in the Neuroscience area and I have Dr. Joseph Herring, who is head of the clinical program for Suvorexant. And we're very excited to be with you today to share with you some of the data from the late-stage clinical trials that Joe presented at the SLEEP meeting earlier today.

And before we turn it over to Darryle and to Joe, I just want to advance a part of our presentation today. We may make forward-looking statements. And as you know, those forward-looking statements have a risk of not coming to fruition. And for a complete set of the risk factors affecting Merck, you can find those in our Form 10-K that's available on our website.

And with that, I'll turn it over to you, Darryle.

Darryle Schoepp

Thank you, Carol. So it's really a pleasure today to talk to you about Suvorexant. Today we're going to talk about the current sleep market, sleep area in terms of patient need. Then I'll touch on what are the characteristics that we seek in an effective sleep medication. And then last, we'll talk about, why is Suvorexant different?

So first of all, the insomnia market is a large and unsatisfied market. There has a very high prevalence; up to 30% of the general population experiences insomnia. It's about a $2 billion market in spite of considerable generics in the market with about 18 million patients in the U.S. who are treated. About 1/3 or 30% of those patients are chronically treated. So there's a need for chronic medications for this illness as well.

Sleep deprivation and untreated sleep disorders can have a detrimental effect on many, many things. They include your general health, productivity and even job performance. There's a significant portion of patients who are unsatisfied with their current therapies, which we'll talk about really fall the major -- fall into one major class, a different class than Suvorexant. And patients continue to seek therapies, particularly therapies that have strong sleep maintenance and minimal residual effects.

So really the goals of a sleep medication are: first of all, put you to sleep, or sleep onset; also to keep you asleep, or what we call sleep maintenance; and minimal residual effects the next day. And also because, as I mentioned, the 1/3 of patients are looking for chronic therapies, a drug which is safe for chronic use is also highly desirable.

Orexin antagonists target a very different way of putting people to sleep and keeping them asleep. This illustrates that in this table. And particularly, what orexin antagonists do is they target brains. The other major class of sleep drugs all act to the inhibitory neuron, so neurons in your brain. And actually, about 1/2 of those neurons actually contain inhibitory neurotransmitter, GABA. Very -- it's -- the primary CNS inhibitory neurotransmitter has many functions. There are sleep drugs which target GABA receptors, and they do result in sleep. But GABA drugs, things that facilitate GABA, can have many other uses, including antianxiety. They're muscle relaxants. They have anticonvulsant qualities. They can be used as pre-anesthetics because of their anesthetic [ph] qualities, as well as even anesthetic agents.

Orexin is fundamentally a new mechanism for the treatment of insomnia. Orexin is a neuropeptide neurotransmitter in the brain, and the cells that make up these orexin peptides, there are only about 70,000 to 100,000 of these neurons specifically located in the hypothalamus. So if you just do the math, about half -- billions of neurons or GABA and only, let's say, 100,000, 70,000 neurons out of billions that actually make these orexin neuropeptides.

But they're very important neuropeptides because what they do is they control wakefulness, and you can think of insomnia as a disease of inappropriate wakefulness. And so what orexins do is they facilitate the transitions from wake to sleep and sleep to wake. So by blocking orexin receptors, we can facilitate those transitions of people going from a wake state to a sleep state. And if they wake up in the middle of the night, it actually helps them just go back and go back into sleep. So it's fundamentally a very unique, exciting and different mechanism.

This shows you -- it illustrates kind of a nice data, which Merck Labs has shown in both animal species, as well as their -- at the meeting here in human studies, how the orexin antagonists are different from the GABA drugs. And this is on sleep architecture. So in these studies, what you look at basically is sleep architecture and look at the EEE spectrum. And if you look at the 2 compounds to the left, which is the active ingredient of LUNESTA and Ambien -- zolpidem and eszopiclone -- what you see is a change in the EEG spectrum by these drugs because they're basically not producing a sleep, which is like what you might call and I'd call a normal sleep. And if you look off to the right and with the same data was shown with Suvorexant, this is another molecule, what you see is that ratio is very close, it's really no different than one. So these drugs actually work by facilitating what you might call a physiological, more normal school sleep. So it's one example of data, which makes us so excited about this new mechanism.

So now I'm going to turn it over to my clinical colleague, Joe, who will go through some of the clinical data on Suvorexant. Joe?

Joseph Herring

Okay. Thank you. So what I'll do now is run through some slides about our -- that include data from our 3 pivotal efficacy studies. These were just presented today actually at the SLEEP meeting, and these results were just presented a little over an hour or so ago, so really hot off the press here.

So we did 2 pivotal efficacy trials in Phase III, Protocol 28 and 29, and we measured the efficacy of Suvorexant daily over a 3-month core treatment period. So we looked acutely when initially taking the drug. Then, we looked at a month 1 time point, and we looked at it on a month 3 time point, and there were 2 trials. And this is a subjective measure, so that means there's a patient-report measure. The patient adds into their diary daily how they felt like they slept. So this is a measure called subjective time to sleep onset. It measures the amount of time that the patients report having to fall asleep. And so you can see that to the right of 0 favors Suvorexant, which means that these are statistically significant results, and you can see the magnitude of the increase between the 2 trials and the consistency over the 3-month treatment period.

So that's a sleep onset measure. And then they also reported how much they thought they slept over the night. And so this is subjective total sleep time. The patient recalls the amount of time they felt like they slept, and that's compared back to their baseline levels and subtracted from placebo. And similarly, at the acute time point of week 1, month 1 and month 3, you can see the treatment effect sizes consistent between the 2 trials and favoring Suvorexant significantly over placebo.

We also measured objective sleep in these trials. So in addition to the patients who are doing the patient report diary on a daily basis, they had 3 occasions of which we had them in a sleep lab and measured their sleep overnight with electroencephalography with the wires on overnight.

So this is the onset measure. It's called latency to onset of persistent sleep, or LPS. And again, we looked acutely at night 1, month 1 and month 3. And you can see generally for all the endpoints favoring Suvorexant except for this one time point at month 3 and then the one trial, Protocol 29, where the confidence interval includes 0, and so that result was not statistically significant. But the others obviously were.

And then on the maintenance side, this measure is called wake after sleep onset, or WASO, and here you can see the treatment effect sizes ranging from, say, modest 20 minutes up to 40 minutes over the entire duration of their core treatment period favoring Suvorexant.

This is another way of looking at the same data. This is the subjective data, again, of total sleep time. So this is the patients' recall of how much more they felt they slept overnight relative to their baseline. And you can see at week 1, month 1 and month 3, the light green being placebo, the brown color Suvorexant low dose and the darker green being Suvorexant high dose. And so this shows what the patient actually reports relative to their baseline and, for example, at month 3, the patients reporting about an hour of additional sleep than their baseline on Suvorexant. And placebo subtracted, that's about a 20-minute difference and highly significant, as you can see.

Another question is, how does Suvorexant maintain sleep over the night? And so we've looked at this data by thirds of the night in terms of this wake after sleep onset measurement. And so you can see a separation from the placebo, which is the brown color over the first 1/3, second 1/3 and then the third 1/3 of the night. And so these differences out here at the third 1/3 indicate that the sleep-promoting effects of Suvorexant were maintained throughout the entire night. This is actually a significant finding relative to some of the other agents. For example, the benzo and non-benzo mechanisms have to have a shorter half-life in order not to incur undue residual effects, and as a result, sacrifice some maintenance in the latter part of the night.

So in terms of our residual effect profile, this is reporting the incidence rates in which patient report some next day sleepiness across the doses in the 2 trials. We call that somnolence. These are the somnolence adverse events. And this is the combined age data. We studied both elderly and non-elderly in the same trials in Protocol 28 and 29. So the high dose is in brown, and you can see the rate of incidence of somnolence being about 11% for the combined age database in non-elderly and about 10% in elderly and similar in the second trial, compared to placebo, where the incidence range from about 3% to 5%. And you can see in green, the low dose somnolence rates being lower than high dose and are very acceptable.

Additionally, when the patients were in the sleep lab and had the polysomnography overnight, the next morning, we had the opportunity to do an objective assessment of residual effects. This is called the Digit Symbol Substitution Test, and by that measure, there was no evidence of clinically meaningful residual effects.

We also looked for rebound and withdrawal upon discontinuation of the drugs, or after 3 months of therapy. Some patients were switched from Suvorexant on to placebo. And what we saw through those analyses is that there's no evidence for a withdrawal syndrome, as assessed by this Tyrer Withdrawal Benzodiazepine Questionnaire. And also, upon stopping Suvorexant at the end of the study treatment periods, patients experienced no insomnia rebound symptoms of clinical concern.

In the year-long study, Protocol 9, that was a one-year Phase III, randomized, double-blind study that we also presented earlier today. We only studied the top dose of Suvorexant in this trial, so the 40 milligrams dose in non-elderly, 30 milligrams in elderly. It was placebo-controlled. This is actually the first daily administration study over a year duration to assess the safety and efficacy of a new sedative-hypnotic. On the left is the sleep onset effect, the black line being placebo and green being Suvorexant for sleep onset. So this is the subjective time to sleep onset measure. And you can see significantly different than placebo and sustained over the year with nominal P value less than 0.01.

And then similarly on the sleep maintenance side, subjective total sleep time, where black is now placebo and the increase in total sleep time reported by patients in green, you can see the consistent increase in subjective total sleep time over the year and, again, significant with the nominal P value of less than 0.001.

Additionally, in this long-term study, where we assessed patients for an entire year for safety in terms of the safety summary, you can see the percents here for patients that had greater than or equal to one adverse experience, about 70% on Suvorexant, 64% on placebo. You see the rate for drug-related AEs: 35% Suvorexant, 21% on placebo. And then the discontinuation rate due to adverse experience being low and similar to placebo at 12% versus 9%.

And then in terms of the common AEs, the patients reported over this entire year, 12-month treatment duration, you can see the incidence of this where if over the course of the year, the patient came to a visit or called in and reported having experienced any of these symptoms, that's what's counted here, and 13% somnolence over the year in this study on Suvorexant versus 3% on placebo. And you can see the rates of some of the other events being very similar to placebo in terms of headache, nasopharyngitis, fatigue at 6.5% versus 2% on Suvorexant. But generally, a very good safety profile. These rates were all low, and we saw no evidence of a safety signal of clinical concern.

Additionally, we looked at prespecified events of clinical interest, we call these ECIs, over the 12-month treatment phase of that study. And some of the things that we looked at relate to the things you do when you develop a new CNS-active compound. So, for example, interested to know whether there's overdose cases. Does this increase the likelihood of suicidality? And then also looking at sleep-related events like sleepwalking as a complex sleep-related behavior; sleep-related hallucinations; excessive sleepiness; sleep paralysis, which is a sense during the night of some awareness of being unable move; and cataplexy, which relates to the new mechanism of action of orexin antagonists, as well as being interested in falls. And we did combine age trials so we had a lot of elderly in our trials. So this is the percent; 2% versus 3% on Suvorexant. So that's a good profile. And then these serious adverse events are similar between groups, and drug-related serious adverse event rate is very low.

So in general, the story here with all this information, we can see there are a lot of zeros or very small numbers, is that sleep-related adverse events on Suvorexant were generally similar to placebo. We've had 150,000 patient-nights in this trial. It's a year-long trial with a lot of patients and saw no events of cataplexy. We did look at mood over the course of the year to be sure that the drug and long-term treatment didn't change mood by the quick inventory of depression symptoms, and we didn't see changes there. And as I mentioned, there is no imbalance -- serious adverse events in the trial, so overall, very well tolerated.

Additional Suvorexant data of note from this trial, because it really was exceptional in being a long-term, a year's study, was that we looked to see that there were weight changes. There were no meaningful weight changes in the study observed over the year of treatment. Of course, that was an opportunity for new adverse experiences to appear. We saw no evidence for emergent AEs over time. And we saw no clinically significant rebound by the patient-reported measures, no clinically significant withdrawal, and safety results were comparable between the 2 age subgroups. So we had elderly and non-elderly in the same trial. So, of course, we've looked at all the data by age subgroup and it was tolerated well by both groups.

So at this point, well, this is the summary. Our next step at this point is to file Suvorexant. We're very excited about it. It's a new mechanism that's completely novel, and it's delivering sort of the whole package of attributes that you'd want with a sleep medication. You have sleep onset, sleep maintenance, minimal residual effects and safe for chronic use. And that's our filing target.

Darryle Schoepp

Thank you, Joe. Thank you.

Joseph Herring

Thank you.

Darryle Schoepp

I guess, it's time for questions.

Question-and-Answer Session

Carol Ferguson

We would welcome any questions that you have right now to Darryle or to Joe.

Darryle Schoepp

They need a microphone.

Seamus Fernandez - Leerink Swann LLC, Research Division

Seamus Fernandez of Leerink Swann. So just a couple of quick questions. I think you guys had also done a driving study as well. Can you talk a little bit about the driving study and the residual affects there in the driving study? And then separately, in terms of -- the sleep onset looks good, maintenance looks good, minimal residual effects. Why not do a study versus either Ambien head-to-head, which I assume would that be required for international filings versus a U.S. filing and then to potentially see overseas filing? So again, would you do something versus Ambien or Ambien CR or LUNESTA?

Darryle Schoepp

Maybe I'll start with the last question first, then I'll hand over maybe to Joe. So we -- so this is a new mechanism. These studies which we run are extremely comprehensive. As you saw, we've ran a one-year safety study, where we dosed every day for a year and assessed both safety and efficacy. We've had to run both subjective and objective trials for one night or a week on acute, initially 1 month, 3 months, so those different time points. This is our first time any drug has really had to be put through that type of pace. And as I mentioned, Suvorexant is a new combo [ph]. So what we've done is established that the orexin antagonist mechanism, as mentioned in the last slide, it meets all the characteristics of putting to sleep, keeping you asleep, safe for chronic use and by our assessment, it looks like reasonable residual effects the next day. 90% of people, safe to say, for example, that not report somnolence. So we've really shown for that. So we haven't run head-to-head studies. The drugs that are out there were developed a while back, and they haven't had to run similar studies. We chose to run our comprehensive program the way we did to learn, and we've learned that our molecule is quite effective. So on the second part of the question, in terms of running comparator studies, that would simply something you would have to do in Europe, as an example, but not necessarily not in the U.S. All right, Joe?

Joseph Herring

Yes, into driving study question, the elderly driving study data were reported at the meeting, and the profile looked very good there. I don't know if you had an opportunity to see that. We could certainly get the abstract to you. It basically showed that for elderly patients who were assessed on day 2 or day 9 after dosing with Suvorexant that they had no impairment as measured by SDLP, standard deviation of lane position mean analysis, which was the primary endpoint of the study. So very encouraging performance.

Darryle Schoepp

I think there's actually a question back there.

Jessica Fye - JP Morgan Chase & Co, Research Division

Jessica Fye for Chris Schott at JPMorgan. Can you talk about the commercial side and how you're think about positioning the product? Is there may be a specific segment of the market you think Suvorexant would be best suited for given the availability of generic Ambien?

Darryle Schoepp

So we're focused on filing our drug this year. We have, as I mentioned, we have an outstanding profile efficacy, particularly in maintenance. We showed you, for example, that the drug maintains its maintenance effects even through the last part of the night. Example of drugs like -- some of the earlier drugs where they put you to sleep, they really don't have that type of maintenance durability, especially at the end of the evening. So I think that's quite outstanding. And also as we've shown, we -- again, we studied our drug chronically for both efficacy and looking at safety, and that's a very high, high unmet need there. And we've shown that Suvorexant delivered that, I think some of the older drugs haven't had -- they were developed a while ago, but they basically haven't been studied in that manner.

Alison Yang - Barclays Capital, Research Division

Just a question. My name is Alison Yang, Barclays Capital. My senior is Tony Butler. This question is sort of a commercial question. Can you kind of divide out sort of the sleep market? What percent of patients get their scripts from primary care, what percent of patients get their scripts from a specialist? And in terms of how you guys think about this agent, is it going to be specialist focused, premier care focused? And how does Merck think about providing sales force support for it?

Darryle Schoepp

Yes, this is Denise Williams here. Denise is my colleague at Merck on the commercial side. I'll let Denise handle that.

Denise Williams

Sure. So for this particular market, as you've probably seen with some of the other agents, it's largely prescribed by primary care physicians, with a very small percentage by psychiatrists and other sleep specialists. And so as we think about it, we are preparing to launch it into the primary care market. As you know, Merck has a very strong legacy in primary care, very strong sales force competencies and support, and we've been very successful with that. And so as we plan for that, we would expect to leverage all of the capabilities and competencies that we have to do that.

Seamus Fernandez - Leerink Swann LLC, Research Division

This is just a follow-up question so maybe I can ask it directly of you. Are we planning to file in Europe then? Will there be a European filing, or is there not going to be a European filing of this drug? Or again, are we -- I'm just trying to get a better understanding of...

Darryle Schoepp

So our plans are to file in the U.S. We've actually also collected data for, enough subjects to potentially file in Japan in the near future. We haven't talked about our strategy beyond that.

Alison Yang - Barclays Capital, Research Division

Maybe one more. Do you have any thoughts on whether this is going to be a scheduled product, DEA scheduling?

Darryle Schoepp

Yes. So this class of agents, sleep drugs fall in the class of set of hypnotics, which the GABA drugs, the effective ones are actually are controlled substance. They're Schedule IV. We actually don't -- we haven't seen -- I guess, what we would say is we don't see that as a differentiator. Our drug is quite effective as a sedative-hypnotic, and again, it's going to be within that class. The scheduling will be determined by the regulatory agencies and after approval, it will go on and that will occur later. So I guess we'll see how that goes. But we have a quite effective sedative-hypnotic or basically our drug that puts people to sleep and keeps them asleep. So it'd be hard to -- I guess, we wouldn't speculate because that would be a big differentiator.

Seamus Fernandez - Leerink Swann LLC, Research Division

Seamus Fernandez of Leerink again. So when we kind of think about some of the other CNS indications or areas that are affected by chronic insomnia, and obviously, as part of the depression score, you have insomnia as a major indicator. Are there opportunities, whether it be in the U.S. or globally to pursue other indications? And if there are those types of opportunities, where do you sort of see Suvorexant evolving towards?

Darryle Schoepp

So that's a very good question. There is other potential. The science is quite new. Now we know we have an effective and a quite well-tolerated, what looks like very safe mechanism and molecule. So that gives you the opportunity maybe to do more in that realm. We actually have posted on ClinicalTrials.gov 3 trials with our backup molecule, so MK-6096. It was -- some of that was presented before and at the meeting here. It was our backup to -- at Merck, we've always backed up our compounds because we never know what happens. But in case the Suvorexant has delivered very well, so we consider 6096 to be our backup molecule. That molecule we have done sleep studies on. It works very well, similar to Suvorexant. But that compound, we've started trials in some of these other areas, and there's a host of areas that you could talk about and we have. But the 3 things that we've decided to look at initially is neuropathic pain, we're looking at. And we're looking at migraine prevention. And we're looking at depression augmentation. I'll actually let Joe comment a little bit on how we're doing on those studies. You want to comment, Joe?

Joseph Herring

I think it's a great summary that -- those are the 3 trials that are posted. And there's nothing really particularly exceptional about them in terms of design, I mean, different types of endpoints -- pain endpoints, depression endpoints, migraine endpoints -- for the 3 trials. And they're both parallel placebo-controlled trials.

Darryle Schoepp

I think it's because so you have -- there's a number of conditions like migraine, for example, where circadian disruption can lead to more migraine attacks. Migraines are seen a lot in the morning when people get up. If you don't get enough sleep or you get too much sleep, that can trigger migraines. And actually, migraines also have a pretty -- you have -- there are some literature, although it's mixed, about there's abnormal EEG signatures that occur with people who are prone to migraine attacks. So it's a very -- and we also even have some data in preclinical data that orexins might play a role in the pathways that trigger migraines. So we're quite interested in that. In the neuropathic pain area, it's known that neuropathic pain changes, of course, can disrupt sleep. Any kind of pain could make it difficult to sleep. But also sleep disruption will change the threshold for pain in people, and there's even maybe some signs that some of the things that orexins do, maybe in some of these pathways, we're quite interested in that. And then the depression area, the psychiatric disorders in general and sleep; are quite co-morbid, and there's even maybe a potential role for orexins in stress-related phenomena in your brain that are part of, I guess, part of what stimulates you to stay awake. So we would like to see whether or not orexins have potential there. That's the detailed answer. Sorry about that.

Derek Yuan - UBS Investment Bank, Research Division

This is Derek Yuan for Marc Goodman at UBS. Just a quick question. In your opinion, how satisfied do you feel with patients of Ambien and the kind of key needs there? And then how do you view kind of the uptake of Suvorexant in the future given generic Ambien?

Darryle Schoepp

Yes. It's sort of the same question, kind of stated differently. So again, what we're trying to fulfill is that basically that these 4 major needs in one molecule and one mechanism, which you can get into long discussion with the other drugs and which ones of these needs they fill and don't fill depending on whether you're talking about, I guess Ambien, Ambien CR and LUNESTA. But essentially, what we have in this mechanism is something that puts you to sleep, the same compound, one compound, one mechanism puts you to sleep. It keeps you asleep, and particularly strong maintenance effects, I think, which are seen throughout the entire night, which is quite beneficial and actually quite unique. Again, minimal next-day effects for a vast majority of patients. And that's quite remarkable if you look at the information that Joe showed showing sleep throughout the last 1/3 of the night, that you have such low reports of somnolence and next-day residual effects in these patients and even have clean DSST even though these people have spent the whole night sleeping. So that's quite, quite remarkable thing I think the mechanism is delivering. The last thing is safe and effective for chronic use. So you can take Suvorexant every day for a year. It seems very well tolerated and as Joe showed you, there's no tolerance to the efficacy. The efficacy does not wane because the efficacy is just as good in that one-year study at month 12 as it was at month 1. Those are -- if you combined all that data together, it's a quite outstanding package and really separates it from other drugs, past drugs in the sleep area, I guess. And I think it's a great option for patients.

Carol Ferguson

There are a few questions coming in from e-mail that I'll read to the room. These are coming from Greg Gilbert with Bank of America. Greg asks, in the driving study, how many hours post-dosing did the driving simulation occur?

Darryle Schoepp

Go ahead, Joe.

Joseph Herring

Yes, so first of all, it was an on-the-road study. So it wasn't a simulated drive. They actually did go out and drive the car on the road, and the test occurred 9 hours after dosing.

Carol Ferguson

And the second question, how would you expect onset to be described in the label?

Darryle Schoepp

I guess I wouldn't comment on that. I don't really know the answer. I guess I wouldn't comment how it would be described exactly in the label. We plan on filing our drug this year. Labeling discussions hopefully will occur as part of that.

Carol Ferguson

Okay. And last question coming from Greg. Commercially, is it reasonable to assume that given the generic options available that you'd have to pay to avoid prior authorization on Tier 3?

Darryle Schoepp

Well, that's -- I'll leave that to my colleague.

Denise Williams

Well, at this stage, until the drug is approved, we can't necessarily speculate on what payers will do. I think that we've -- if we just look at our own history, we've seen products compete successfully in generic markets. We've seen that with JANUVIA and; we've seen that with other products. And so I think it's premature to speculate what -- whether or not we'll have to pay to avoid prior auths. I think we'll learn that as the product comes to market. But as Darryle has alluded to, the profile of this drug is very strong, and I think that's what people sell it on.

Carol Ferguson

Are there any questions in the room?

Alison Yang - Barclays Capital, Research Division

This is Alison Yang again. Maybe just to ask a basic question. Can you describe how the patient takes this pill? Is it at dinner, after dinner? If you take the pill, can you operate motor vehicles? Can you do anything? Can you just kind of describe how the patient actually uses to the day-to-day basis? And then it's interesting this is a daily-use study. What occurs when patients miss a pill? Do they have rebound? Do they have withdrawal? Can you kind of describe maybe on a day-to-day basis how this affects the patient's daily activities?

Darryle Schoepp

Well, go ahead, Joe.

Joseph Herring

Well, we -- in the trials, as part of the procedures of the trial, the patients were instructed to take the medication just prior to going to bed because we anticipate and have shown that the drug has sleep onset inducing effects, that the general guidance for this type of medication for sleep medication is that you take the medication prior to going to bed, and you don't actually plan to do additional activities like operating heavy machineries, kinds of things. So that was the instruction given to the patients in the trials, and the people followed those instructions. And as I mentioned at the time points where patients discontinued the medication and we measured rebound and withdrawal formally, there was no evidence of clinical concern. We haven't done a intermittent-use study, maybe to address more specifically the sort of question you're asking, but we have done Phase I studies where there was single doses of the medication administered, and those patients didn't report adverse experiences of concern, either.

Seamus Fernandez - Leerink Swann LLC, Research Division

Seamus Fernandez again. So just can you clarify for us what claims you might actually be seeking or an indication you might be seeking in the label because, I mean, there's clearly an opportunity to pursue a chronic use indication. And I don't believe any of the other products actually have that in the label despite the fact that there's quite a bit of use in that regard.

Darryle Schoepp

I'll just a make brief comment. Maybe, Joe, if you want to add to it. I mean, we've studied this drug for chronic use. That's part of the package that we're going to be submitting. We've done more work in that domain than any other sleep drug previously, and the data we've shown you is quite remarkable. So, I mean, that's the package that we're going to file. Joe, you want to?

Joseph Herring

No, I agree. Absolutely, the way the program was set up with the 3-month core treatment periods and the 2 pivotal efficacy studies and with the one-year study that this overall efficacy and safety package should support no short-term use restriction as a limitation. But again, we have the right package to support chronic use.

Carol Ferguson

I have an additional question coming in an e-mail. This is from Odysseus Kostus [ph] at ISI Group. And Joe, I think you mentioned earlier that in the one-study, there was no meaningful weight change, that, that was an item that we looked at. And so Odysseus is asking for some additional clarification on that. What does no meaningful weight change mean?

Joseph Herring

Well, specifically there was no difference from placebo-treated patients over the year.

Jessica Fye - JP Morgan Chase & Co, Research Division

Jessica Fye for Chris Schott again. Maybe just one more. Just trying to kind of understand the market a little more. I think one of the slides said that something like 30% of the patients are chronically treated. Do you have a sense of what percent of scripts they account for? Are they some kind of significant percentage of the market, that kind of group?

Darryle Schoepp

Yes, if you want to go ahead, Denise.

Denise Williams

It's about 60%.

Carol Ferguson

Are there any other questions in the room?

Seamus Fernandez - Leerink Swann LLC, Research Division

I'll just ask just one last question

Carol Ferguson

Okay.

Seamus Fernandez - Leerink Swann LLC, Research Division

So just as one final question. If you were going to pursue a head-to-head study, is the restriction or the limitation that -- or is it -- would it be a challenge to actually get an IRB to approve, an investigational review board, to actually review or allow you to go head-to-head in a chronic study versus another hypnotic? Because it would seem to me like you could really separate on the safety in a chronic insomnia study going head-to-head versus either Ambien or Ambien CR or LUNESTA.

Darryle Schoepp

Well, an IRB, I don't know. Joe, do you want to [indiscernible]?

Seamus Fernandez - Leerink Swann LLC, Research Division

If it's not approved, will that still be used -- well, it is used that way.

Darryle Schoepp

Yes, that's a good question.

Joseph Herring

I'd agree it's a good question. I don't know that we have the right answer yet because once we, and if we contemplate doing those types of studies, we'll need to have some dialogue with the appropriate agencies about what's allowed and within certain countries, what drugs are approved. So it's a complicated question.

Darryle Schoepp

Good question, actually.

Carol Ferguson

Well, thank you, all, for joining us here in Boston and on the webcast. It was great to share with you our data today for Suvorexant, one of a number of major filings that are coming up for Merck in the next 18 months. And so we look forward to filing Suvorexant by the end of this year. And we thank you, Darryle and Joe, for spending your time with us today, walking us through the data and answering our questions. So thank you very much. Thank you.

Darryle Schoepp

Thank you.

Joseph Herring

Thanks.

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