Patients could have another choice to treat their obesity in six months. Maybe even sooner.
Orexigen Therapeutics (NASDAQ: OREX) announced today the resubmission of its application for the approval of Contrave. The obesity drug was originally turned down by the Food and Drug Administration in 2011. The agency was worried that slight elevations in pulse rates and blood pressure were a potential sign of more serious cardiovascular side effects.
The FDA made Orexigen run a large trial to exclude the possibility that Contrave was causing excessive cardiovascular risk. Last month, Orexigen announced interim results from the study, which concluded that, if there is an increase in cardiovascular risk, the risk is highly likely to be less than double the cardiovascular risk of someone not taking the drug.
The exact risk isn't known because this is an ongoing study. As more events -- heart attacks, strokes, and cardiovascular deaths -- occur, the risk will become clearer. In theory, Contrave could have a cardiovascular benefit, because patients are losing weight.
The FDA seems highly receptive to getting Contrave on the market. In an unusual move, it's allowing Orexigen to resubmit its application without the data from the safety trial, thus starting the six-month review clock. Once the final report on the data is completed in the next two months, it'll be submitted as an addendum to the application.
It's almost like the FDA feels bad for making Orexigen run a large trial that turned out to show the agency was worried for no reason. It seems possible the FDA might not even take the full six months to approve the drug, although given the size of the trial, I would expect it will take a majority of the allotted time.
If the FDA approves Contrave this time around, the drug will join VIVUS' (VVUS) Qsymia and Arena Pharmaceuticals' (ARNA) Belviq, which were approved last year. Both obesity drugs were also initially rejected by the FDA around the same time as Contrave, but the FDA didn't make Arena Pharmaceuticals or VIVUS run longer trials, shortening their path to approval.
The efficacy and safety data on Contrave puts it somewhere between Qsymia and Belviq. Qsymia produces the most weight loss of the three, but has potentially serious side effects, including birth defects if taken by pregnant women. Belviq produced the least weight loss of the three, but is also considered the safest.
I don't buy the Goldilocks theory that Contrave will succeed where Qsymia and Belviq have struggled just because of the intermediate efficacy and safety. The obesity market is no fairy tale.
Arena Pharmaceuticals' marketing partner Eisai and VIVUS have struggled to sell their obesity drugs because it takes time to convince doctors and patients that the risks and financial costs are worth taking the new drugs. In the short term, Orexigen's entry could end up helping the currently approved drugs. A third player could end up helping expand the entire market, especially since Contrave will be sold by Orexigen's marketing partner Takeda, which brings experience from its megablockbuster diabetes drug Actos.
