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FDA Approves First Non-hormonal Treatment For Menopause Related Hot Flashes

Specialty pharmaceutical company Noven Pharmaceuticals, Inc. announced Friday that the U.S. Food and Drug Administration has approved its Brisdelle (paroxetine) capsules as treatment for moderate to severe hot flashes (vasomotor symptoms) associated with menopause. This is the first and only non-hormonal treatment for moderate to severe hot flashes approved by the FDA.

The drug was not recommended for approval by the FDA's advisory committee for Reproductive Health Drugs, deeming it as too much risk of suicide ideation and osteoporosis with minimal benefit over placebo, However, the FDA went ahead with approval for the treatment.

The drug contains selective serotonin reuptake inhibitor paroxetine mesylate. However, the mechanism by which Brisdelle reduces hot flashes is unknown.

"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments. Today's approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause," said Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.

Most of the other FDA-approved treatments for hot flashes contain hormones such as estrogen alone or estrogen plus a progestin.

Hot flashes affect 75 percent of menopausal women or 32 million women in the U.S. annually. Hot flashes are characterized by a sudden, temporary onset of body warmth, flushing and sweating. Hot flashes are not life-threatening, but are disruptive and impact women's overall quality of life, affecting their mood and their ability to sleep.

According to the North American Menopause Society, hot flashes are the most common menopause-related discomfort, which can persist for 10 years or more. However, the exact cause of hot flashes is not known.

Brisdelle, the low-dose version of paroxetine, contains only 7.5 mg of paroxetine as a mesylate salt and is dosed once daily at bedtime. Other medications such as GlaxoSmithKline's (GSK) Paxil and Noven Therapeutics' Pexeva contain higher doses of paroxetine and are approved for treating conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder and generalized anxiety disorder.

Noven Pharmaceuticals is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu's U.S. growth platform in prescription pharmaceuticals.

Noven will commercialize Brisdelle in the U.S. through its Noven Therapeutics Women's Health division and estimates that Brisdelle will be available in US pharmacies in November 2013.

FDA noted that the approval is based on the results from two randomized, double-blind, placebo-controlled studies on 1,175 postmenopausal women that showed reduced hot flashes compared to placebo.

The women suffering from moderate to severe hot flashes (a minimum of seven to eight per day or 50-60 per week) were treated over a period lasting 12 weeks in one study and 24 weeks in the other study. The most common side effects in patients treated with Brisdelle were headache, fatigue, and nausea/vomiting.

by RTT Staff Writer

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