FDA OKs low T nasal gel, male incontinence device

June 2, 2014

The FDA has approved a nasal gel for men with hypogonadism and has granted clearance to a treatment for urinary incontinence in men. Separately, two drug makers are approaching the agency about regulatory approval for an over-the-counter version of a phosphodiesterase-type-5 inhibitor.

The FDA has approved a nasal gel for men with hypogonadism and has granted clearance to a treatment for urinary incontinence in men. Separately, two drug makers are approaching the agency about regulatory approval for an over-the-counter version of a phosphodiesterase-type-5 inhibitor.

The new testosterone gel, known as Natesto (formerly CompleoTRT), is self administered via a nasal applicator, which manufacturer Trimel Pharmaceuticals Corp. says minimizes the risk of secondary exposure of testosterone to women or children.

“In my practice I regularly encounter men demonstrating symptoms of hypogonadism, and physicians will increasingly see this as the North American population ages. For these patients seeking to restore their testosterone levels, Natesto will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market,” said Jeffrey Rosen, MD, of Clinical Research of South Florida, Coral Gables, in a statement from Trimel.

In a phase III trial, 78 patients were treated with 33 mg of testosterone nasal gel daily. Of these, 73 men were included in the statistical evaluation of efficacy on day 90 based on the intent-to-treat population. Ninety percent (90%) of these patients had average serum testosterone concentrations (Cavg) within the normal range (300 to 1,050 ng/dL) on day 90.

The agent is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone. The recommended dose is 11 mg of testosterone (two pump actuations, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg.

Also receiving FDA approval is InToneMV, a noninvasive treatment option and comprehensive pelvic floor rehabilitation program for the treatment of men with bowel and urine leakage. The device consists of a customizable probe with muscle stimulation that strengthens pelvic floor muscles and provides voice-guided volitional exercise and visual biofeedback to reinforce proper completion of exercises, according to a press release from InControl Medical, the device’s manufacturer.

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Data from each home-based session is recorded so that the health care provider can guide progress during follow-up visits.

"Our original InTone device that was FDA listed as a Class II Medical Device for the treatment of female urinary incontinence helped so many that we had to design InToneMV, which is a much smaller and more comfortable treatment solution to help both men and women with atrophy… InToneMV works. Men no longer need to suffer with fecal or urinary incontinence,” Herschel Peddicord, founder and CEO of InControl Medical, said in the release.

In related news, Sanofi and Eli Lilly and Co. recently announced that they are pursuing regulatory approval on a non-prescription version of the phosphodiesterase-type-5 inhibitor tadalafil (Cialis).

Tadalafil, which was approved by the FDA in 2003 for the treatment of erectile dysfunction, is currently only available by prescription. The drug is also indicated for the signs and symptoms of BPH and both erectile dysfunction and the signs and symptoms of BPH.

Under the terms of an agreement between the two companies, Sanofi holds the exclusive rights to apply for approval of Cialis over the counter in the U.S., Europe, Canada, and Australia. The company also holds exclusive rights to market Cialis OTC following receipt of all necessary regulatory approvals, according to a statement from both companies. If approved, Sanofi said it anticipates providing Cialis OTC after expiration of certain patents.

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