Without a DEA schedule determining the abuse and addiction potential of Belviq, Arena and its marketing partner Eisai cannot begin to sell the weight-loss pill. FDA approved Belviq on June 27, 2012, so the wait for DEA scheduling has now dragged on for nine and half months.
The DEA doesn't operate under any time constraints when it comes to finalizing drug schedules, but a six or seven-month review is pretty typical. For some unknown reason, DEA is taking a longer time to push Belviq out the door.
Arena has already manufactured and shipped Belviq to Eisai, which is ready for commercial launch within days of receiving the final word from the DEA, says Arena spokeswoman Cindy McGee. Arena is unaware of any problem that would be delaying the DEA decision, she adds. Once launched, Belviq will compete against Vivus' (VVUS - Get Report) weight-loss pill Qsymia.The long wait has led to some speculation that DEA may be reconsidering its initial recommendation to place Belviq in the Schedule IV "low potential for abuse" category, perhaps bumping up to Schedule III, which consists of drugs with "moderate or low physical dependence or high psychological dependence." Practically speaking, slotting Belviq as a Schedule III or Schedule IV drug doesn't matter because both categories allow for five prescription refills in six months. Either way, doctors and patients will have relatively unfettered access to Belviq. Only if DEA chooses to slam Belviq with a Schedule II designation would the drug's access be restricted, but no one really believes that's going to happen. Arena bulls and bear are hating the wait equally but for very different reasons. The bulls believe Belviq is a blockbuster weight-loss drug in the making; bears insist Belviq's middling efficacy dooms the drug to be a commercial flop. Until Belviq hits the market, neither side can declare victory. Arena's stock price remains in stasis, trading between $8-9 per share since last August. Annoying. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein