Arena Pharmaceuticals, Inc. (NASDAQ:ARNA)‘s Belviq, VIVUS, Inc. (NASDAQ:VVUS)‘s Qsymia, and Orexigen Therapeutics, Inc. (NASDAQ:OREX)‘s Contrave were rejected by the Food and Drug Administration within a few months of each other in late 2010/early 2011. But that’s where the stories of these obesity drugs diverged.
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) and VIVUS, Inc. (NASDAQ:VVUS) were able to get their drugs approved without running another long costly trial. Belviq was the first drug approved, but Qsymia actually launched first while the DEA held up Belviq to decide how likely it was to be abused. Both obesity drugs are now on the market.
Meanwhile, Orexigen Therapeutics, Inc. (NASDAQ:OREX) is still waiting to get back in front of the FDA. Fortunately, it appears the biotech won’t have to wait much longer.
The agency required Orexigen to run a large clinical trial to rule out the possibility that Contrave causes heart problems. The company enrolled more than 10,400 patients and then had to wait for enough patients — 87 to be exact — taking Contrave or placebo to experience a major adverse cardiovascular event before the data can be analyzed.
It’s rather morbid to be rooting for patients to have a heart attack or stroke, but that’s what Orexigen’s investors have had to do over the last year or so.
This week, the independent data monitoring committee, which gets to see the unblinded data, told Orexigen that the 87th major adverse cardiovascular event is expected to occur within the next two months to allow the company to conduct an interim analysis.
Since this is a safety study, Orexigen just needs the Contrave group to have the similar frequency of major adverse cardiovascular events as the placebo group. If it could beat the placebo group, it would be one heck of a marketing tool.
While it seems possible that Contrave could lower the likelihood of cardiovascular events since patients should be healthier after losing more weight than the placebo group, it’s probably asking a lot to see a statistically significant difference during the upcoming interim analysis. The study is expected to be completed in 2017, which is a more realistic time frame to see a difference in the two groups.