The Food and Drug Administration’s Office of New Drugs has ruled in favor of the efficacy of gepirone extended release for treating major depressive disorder. The decision overturns a decision by the agency’s Psychopharmacologic Drugs Advisory Committee that said the drug’s efficacy had not been demonstrated, according to Fabre-Kramer Pharmaceuticals.

The Office of New Drugs took into account two trials involving gepirone ER (Travivo) with more than 5,000 participants. Both trials had highly positive results, with effect sizes similar to other antidepressants approved by the FDA. Travivo was well tolerated and had a favorable safety profile for trial participants. The most frequent side effects were lightheadedness and nausea, which were usually mild and related to a dose increase.

Travivo, manufactured by Fabre-Kramer, is an antidepressant with a unique mechanism of targeted 5-hydroxytryptamine1A agonism. This mechanism treats depression without significant side effects, particularly sexual dysfunction.

“Travivo is a standout drug that offers a truly unique mechanism, compared with current therapies on the market and it’s an important addition to the armamentarium to treat depression. What’s more, the FDA’s decision will have a positive effect on the future development of drugs in this class,” Dr. Stephen M. Stahl, professor of psychiatry, University of California, San Diego, and founder of the Neuroscience Education Institute said in a press release.

Innovative Science Solutions (ISS) provides consulting services to a range of firms, including pharmaceutical companies. Find the press release about the development here .

lfranki@frontlinemedcom.com

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