Arena’s FDA-Approved Weight Loss Pill Clears DEA Hurdle
Arena Pharmaceuticals Inc. (ARNA)’s Belviq, the weight-loss pill approved in June by the U.S. Food and Drug Administration, was cleared to start sales next month after a separate review found the drug’s abuse potential to be low.
The Drug Enforcement Administration will classify Belviq as a Schedule IV drug, the second-least restrictive designation on a five-step scale, according to a rule made public today. The DEA reviewed Belviq because the agency said the active ingredient, lorcaserin, can produce a high or hallucinogen effect at doses greater than those used to produce weight loss.
The DEA designation removes the last known hurdle for San Diego-based Arena to market Belviq, which may be made available to patients as soon as June 7, Andrew Berens, a Bloomberg Industries analyst, said today in a note. Belviq in June was the first obesity drug approved by the FDA in 13 years.
Arena licensed the medicine to Tokyo-based Eisai Co. (4523) to sell in the U.S. The pill mimics some of the action of fenfluramine, part of the fen-phen appetite-suppression drug combination pulled from pharmacies 15 years ago when it was linked to heart abnormalities.
Belviq will have restrictions on distribution and storage and prescriptions may not be filled or refilled more than six months after they’re written or be refilled more than five times unless renewed by a doctor, according to DEA.
The FDA approved Vivus Inc. (VVUS)’s obesity pill Qsymia in July. That drug, which combines two previously approved ingredients, came to market in September, and is also listed as Schedule IV by the DEA.
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