Belviq Gets Final Endorsement To Begin Sales

Belviq Gets Final Endorsement To Begin Sales

Arena Pharmaceuticals’ prescription diet pill Belviq has received the last regulatory approval needed to commence sales, the San Diego corporation said Tuesday. The diet pill will be Arena’s first product on the market.

The U.S. Drug Enforcement Administration rated Belviq as a Schedule 4 controlled substance, indicating a fairly low risk of abuse. Belviq was permitted by the Food and Drug Administration in 2012, but DEA scheduling was needed before Belviq sales could begin.

Sales of Belviq can begin as early as 30 days from publication of the DEA consent, likely in the Federal Register today, Arena said. Sales are being handled by Arena’s marketing partner, Japan-based Eisai Pharmaceuticals.

Arena shares closed at $8.34, up 82 cents, or 11 percent, for the day.

Belviq reduces appetite, allowing people to feel full while eating less. It’s to be taken along with a plan of exercise and diet. Arena says the drug will give those trying to lose weight the extra push needed to help them succeed.

Eisai said in March that the wholesale cost of Belviq will be $199.50 for a bottle of 60 10mg tablets, a one-month supply.

The drug targets a cellular molecule called a receptor, causing the feeling of being sated. The receptor is normally activated by the neurotransmitter serotonin. Other weight-loss drugs produce this effect by stimulating serotonin production. However, such drugs have been found to cause health problems, such as abnormalities in heart valves.

One of the serotonin-stimulating drugs, fenfluramine, was withdrawn from the market in 1997 after a number of deaths were attributed to it. It was part of the popular weight-loss combo fen-phen, which also contained phentermine.

A rival weight loss drug, Qsymia, contains phentermine and topimirate, an anti-seizure drug. Mountain View-based Vivus began selling Qsymia last year.

Safety questions have dogged both Qsymia and Belviq, because of their similar mechanism of action. Arena says Belviq is safer because it is an entirely new drug that selectively activates just one of the serotonin receptors, instead of all receptors that serotonin targets.

Continuing questions from European regulators led Arena to withdraw an application to market Belviq in Europe. Last October, Qsymia was rejected for sale in Europe.

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