The FDA Adverse Events raw data for Q4 of 2013 have been released, and while the exact information relating to the nature of adverse events will take some time to make its way to the public, it is possible to search through the raw data to see the number of times that a particular drug comes up within the data. We can then look at the number of scripts that were sold in the given period and arrive at a ratio of reported adverse events to the number of scripts sold. I analyzed the data for Belviq from Arena Pharmaceuticals (NASDAQ:ARNA) and Qsymia from Vivus (NASDAQ:VVUS). There are a couple of items that investors should consider when looking at what I am presenting here:
- An adverse event can be a very simple thing. In fact, it could be as simple as a headache. In contrast, it could also be very serious and require hospitalization. An adverse event could be caused by the drug, or even an interaction with another drug.
- Qsymia had been on the market for a little over a year with this data. Belviq was on the market for 6 months
- During Q4 of 2013 Qsymia sold about 124,100 scripts
- During Q4 of 2013 Belviq sold about 61,200 scripts
- The data published by the FDA, at this point is in raw and coded form. Exact nature of adverse events will likely be available in several months.
- It should also be understood that an adverse event may take months to show itself. What I am presenting here is a ratio of reported adverse events in a given period vs. the reported scripts sold in the same period.
- Both Belviq and Qsymia had their respective highest raw total of reported events to date
This data, even in its raw state, was pretty good news for Belviq and pretty bad news for Qsymia. Again, I must stress that we do not know the nature of the adverse events. On with the data:
Arena and Belviq
During Q4 of 2013 Belviq saw script sales at about 61,200 according to industry tracker IMS Health. During the quarter the adverse events reported to the FDA totaled 89. Of the 89, 88 contained the name Belviq and one had just the more formal name Lorcaserin. The ratio of adverse events to scripts sold was an impressive 1 event for each 688 scripts sold.
This data is just the second quarter of data available on Belviq. Even with the FDA adverse event data being at least two quarters behind, the numbers seem to be impressive and speak to a good safety profile for Belviq. The essence of this is that 0.14% of scripts sold result in a report to the FDA
Vivus and Qsymia
During Q4 of 2013 Qsymia saw script sales at about 124,100 according to IMS Health and company SEC filings. During the quarter the adverse events reported to the FDA totaled 954, The ratio of adverse events to scripts sold was a not so impressive 1 event for each 130 scripts sold.
This data speaks to a much higher reporting frequency than the competitor. While Belviq has 0.14% reporting adverse events, Qsymia has 0.76%. Simply stated, given the data from this past quarter, a patiet taking Qsymia was 5.4 times more likely to report an issue of some sort.
What Will This Mean?
At this early stage, the data is still in its raw form. Sites that reformat the data to make it readable to consumers and doctors will not likely have this data published for a few months yet. The Q3 data from 2013 was just published on FDAble.com about a month ago. The likelihood of a doctor making a prescription decision on this information is very slim. However, in the months ahead, when this information becomes well known, it could very well be used by sales reps working for Eisai and representing Belviq. In addition, once the data is published in a readable form, doctors will be able to quickly assess not only the number of events, but the exact adverse reactions.
There has long been the thought that Belviq has a better safety profile than Qsymia. On the other hand, there is a general thought that Qsymia is more effective. A simple yet unscientific thought process maybe this question. Is taking a drug that might be twice as effective worth 5 times the risk?
Lastly, we are now just a few weeks away from the potential approval of Orexigen's Contrave. Adverse event data on Contrave will trail sales by 6 to nine months. The general consensus is that Contrave is in between Belviq and Qsymia in terms of both efficacy and safety. That presents an interesting dynamic in the next year or so. Stay Tuned!
Disclosure: The author is long ARNA. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: I have no position in Vivus