FDA approves agents for ED, renal angiomyolipomas; OAB agent launched

The FDA recently approved new treatments for erectile dysfunction and renal angiomyolipomas, and a previously approved agent for overactive bladder has been launched.

In late April, Vivus, Inc. announced the approval of avanafil (Stendra) tablets, for the treatment of erectile dysfunction.

More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of avanafil, which met all primary efficacy endpoints at all doses (50 mg, 100 mg, and 200 mg), according to the company. Significant improvement in erectile function was observed for all doses compared with placebo.

"Stendra is the first of a new generation of PDE-5 inhibitors, and the approval marks an exciting new milestone for the millions of men suffering from erectile dysfunction who are in need of a new treatment option," said Wayne Hellstrom, MD, of Tulane University School of Medicine in New Orleans.

The FDA also has approved everolimus (Afinitor) for treatment of renal angiomyolipomas not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).

A pill taken once daily, everolimus blocks the uncontrolled activity of the mTOR kinase, which plays a critical role in the development and growth of the various non-cancerous tumors occurring in patients with TSC.

"This approval underscores the FDA’s commitment to the development of drugs for rare diseases with significant unmet medical needs," said Richard Pazdur, MD, of the FDA’s Center for Drug Evaluation and Research. "It also represents another example of where an understanding of a disease’s underlying biology can lead to more selective drug development."

Everolimus’ safety and efficacy were established in a double-blind, placebo-controlled clinical trial of 118 patients. With half of the patients receiving less than 8 months of treatment, 42% treated with everolimus showed a substantial reduction in tumor size lasting, on average, more than 5 months. None of those receiving placebo had tumor shrinkage.

Everolimus was previously approved for patients with advanced renal cell carcinoma refractory to treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Separately, Watson Pharmaceuticals, Inc. and Antares Pharma, Inc. recently launched oxybutynin gel 3% (Gelnique) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The product is a clear, odorless topical gel that has been shown to be an effective and safe treatment for OAB and is available in a metered pump dispenser. It was approved by the FDA in December 2011.

"The launch of Gelnique 3% further demonstrates Watson’s commitment to invest in building a leadership position in urology, particularly in the overactive bladder market," said Fred Wilkinson of Watson Pharmaceuticals. "The clinical trial demonstrated an early treatment effect versus placebo and improved efficacy over time."

The brand name "Gelnique" is also used for Watson’s oxybutynin chloride gel 10%.

Dr. Hellstrom is a consultant/adviser, investigator, and meeting participant/lecturer for Vivus.

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