FDA approves Vivus’ Stendra for erectile dysfunction

US regulators on Friday approved Vivus’ Stendra (avanafil) for the treatment of erectile dysfunction (ED). The decision marks the first product approval for Vivus, which is also awaiting a decision on its weight loss therapy Qnexa (phentermine/topiramate) in July.

Victoria Kusiak, deputy director of the Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research, said "this approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs."

Stendra’s safety and efficacy was established based on data from three trials involving 1267 patients given one of three doses of Stendra or placebo, for up to 12 weeks, 30 minutes before sexual activity. The drug was found to work in as little as 15 minutes, or about half as much time as Pfizer’s Viagra (sildenafil). In a subset of patients followed for up to an additional 40 weeks to evaluate potential safety problems, results showed that the side effects commonly reported in patients using Stendra did not worsen over time.

Like other phosphodiesterase type 5 (PDE5) inhibitors in its class, including Viagra and Eli Lilly’s Cialis (tadalafil), the FDA warned that Vivus’ drug is not suitable for men who take nitrates for angina because the combination could result in an unsafe drop in hypertension.

Stendra, which analysts predict could generate $68 million in sales next year, is also being evaluated in Europe, where a decision is expected shortly.

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