The day Arena Pharmaceuticals ($ARNA) has been waiting for is now here. The Drug Enforcement Administration has made its decision on Belviq, the weight-loss drug that's been sitting on Arena's launching pad since its FDA approval last June. Belviq is now officially a Schedule IV controlled substance, and Arena can fire up its engines for a launch next month.
Belviq had to undergo DEA review because of its "hallucinogenic properties," DEA said in the Federal Register. As Regulatory Focus reports, the Schedule IV classification is DEA's second-least restrictive. It also happens to be the designation the Department of Health and Human Services recommended for Belviq almost a year ago.
With the agency's approval now in hand, Arena can ready for launch. But DEA is requiring the company to wait 30 days postapproval to actually start selling the new drug. Arena itself hasn't yet commented on the DEA's decision, but as The Street points out, the company has previously said Belviq is ready to roll.
While DEA was mulling over its classification for Belviq, Arena rival Vivus ($VVUS) won FDA approval for its obesity treatment, Qsymia, and quickly launched. That first-to-market advantage hasn't paid off as fully as it might have, however; VIvus chose to develop its own sales force and roll out the drug on its own rather than bringing in a Big Pharma partner. Prescription numbers have been less than impressive.
Perhaps the long-awaited DEA decision will take the sting out of Arena's painful decision last week to pull its application for Belviq approval in Europe. Regulators there had a laundry list of worries about the application. Vivus' Qsymia has been turned down in the EU twice now.