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  • FDA Rejection Of TTNP's Probuphine Should Not Be A Surprise. 0 comments
    May 2, 2013 5:20 PM

    While I realize the FDA generally follows along with their advisory panels vote, this time you should not have expected that.

    It was my opinion that we would see the FDA reject the approval of Probuphine, not because of concerns with the surgical implant but the products efficacy.

    Probuphine was designed to deliver 20mg of buprenorphine over the course of 6 months. This means that each rod would deliver 0.11mg of buprenorphine every 24 hours in a continuous, level dose. Even with 5 rods inserted under ones arm, a paltry .55mgs of buprenorphine would be delivered daily. Let me explain why this (even 5 rods) is nowhere near enough to keep a typical opioid addict out of withdrawal.

    Generally speaking, it requires 8-16mg of sublingually administered buprenorphine to bring an addict out of withdrawal at the beginning of treatment with Suboxone. If you can not get an opioid addict out of withdrawal, then that addict will continue to use illicit opioids. Not because he wants to but because he has too. Now lets consider the bioavailability of sublingually administered buprenorphine which is 25%. If we take a middle of the road figure of 12mg/day at induction this translates to 3mg of buprenorphine making it into the bloodstream from that 12mg dose.

    As you can see, we would need over 27 rods to be SURGICALLY IMPLANTED under ones arm, to bring an addict out of withdrawal!!!

    During these clinical trials it was clear that virtually every addict needed daily rescue with Suboxone to make it through the day. The probuphine showed terrible efficacy. It was insignificant over placebo. Lets consider 4 out of 100 is 4x better than 1 out of 100 yet 4 out of 100 is still TERRIBLE ODDS. I compare it to buying 2 lottery tickets for the 100 million jackpot drawing as opposed to one. Sure you doubled your odds, but your odds are still terrible.

    I personally have 2 addicts in my family, and I asked both of them if they would ever try this product out and both said no way. Why would you go for this product when Suboxone is effective in nearly 100% of patients at stopping withdrawal in its tracks? There is no reason too.

    Another important note here is that all of the major insurance company's pay for Suboxone only if you are in counseling at least a few times a month. I can't see them paying for this treatment and trusting patients to follow through with treatment for 6 months. Not when you are dealing with a population society in general, considers to be dishonest.

    Probuphine did a terrible job at blocking the effects of other illicit opioids after implantation. This is obvious in the fact most patients failed multiple drug tests. As a general rule, patients who are prescribed the proper dose of Suboxone do very well staying off illicit opioids because the Buprenorphine blocks full agonists from binding with the opioid receptors in the brain.

    I believe Titan is unable to get enough buprenorphine released in this form to stop a patients withdrawal. Bioavailability of Buprenorphine is very well studied and I am certain if they could have delivered 3mg per day they would have. Because had they done that, they would have most definitely won approval. As it stands they are not even in the same universe, and I believe this company is far more likely to go bankrupt then ever get this product to market.

    Even if they manage to increase the dose drastically and get approval then I do not believe doctors will ever choose to prescribe this over Suboxone. They make a lot of money on monthly fees treating Suboxone Patients, and they can't charge enough with this patient population to get 6 months worth of fees into one visit. It can not and will not happen. These doctors are motivated by greed.

    Most of the doctors who actually prescribe Suboxone know nothing about the drugs actually in it. They are puppets for what the R&B sales reps tell them. If they cared about their patients they would take the time to learn what they were prescribing them. The fact that they do not, makes their motivation clear.

    Ask any Suboxone patient how much time they see their doctor on refill visits and how much they pay in this cash only business. You will likely get an answer in the neighborhood of $200 a month and less then 1 minute or $100 every two weeks and 15 seconds. Titan can't make these greedy doctors anywhere near what R&B does. Therefore, even should they somehow drastically increase the dose (and pay for another lengthy clinical trail) they will never get a doctor to prescribe it, or an insurance company to pay for it. This is a dead horse, and Im afraid Titan is going to continue beating it right into it's bankruptcy hearing.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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