Arena Pharmaceuticals Inc.’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 designation removes the last hurdle to market Belviq, which will be available to patients once the DEA rule takes effect 30 days after its official May 8 publication, San Diego-based Arena said in a statement. Arena said it will receive $65 million in milestone payments under an agreement with Tokyo-based Eisai Co., which will market the drug in the U.S.
“We are thrilled that Belviq will soon be available in the U.S. as a new treatment option for the medical management of patients who are overweight with a comorbidity or obese,” Jack Lief, Arena’s chief executive officer, said in the statement.
Belviq was the first obesity drug approved by the FDA in 13 years though it needed the DEA’s designation before it could be sold.
Arena rose 11 percent to $8.34 at the close in New York, the biggest single-day increase since Aug. 14. The shares have more than tripled in the past year.
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.’s obesity pill Qsymia in July. That drug, which combines two previously approved ingredients, went on sale in September, and is also listed as Schedule IV by the DEA.