DepoMed Inc. (NASDAQ:DEPO) said it plans to prepare and file a new drug application with the United States Food and Drug Administration (FDA) for Serada (extended-release gabapentin tablets) to treat menopausal hot flashes.
The company said it has completed a Type B pre-NDA meeting with FDA regarding the results of the three Phase 3 clinical trials of Serada (extended-release gabapentin tablets), Depomed's investigational gastric-retentive, extended-release formulation of gabapentin for menopausal hot flashes.
Based on the recent interactions with FDA, the company believes that data from its Serada clinical trial program warrants submission of an NDA for the FDA's review and consideration.
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Chief Executive Jim Schoeneck believes Serada may offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes.
In October 2011, Depomed announced the results of the BREEZE 3 clinical trial of Serada and also announced at that time its intention to meet with the FDA to discuss possible pathways to filing a new drug application (NDA) in light of the results of the three Phase 3 trials of Serada completed by Depomed.
Efficacy data from the BREEZE 3 trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks.
Hot flashes affect 75% of menopausal women or 32 million women annually in the U.S. Hot flashes are characterized by a sudden, temporary onset of body warmth, flushing and sweating. For those menopausal women who suffer, even small fluctuations in body temperature can cause them to experience profuse sweating or severe chills.
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Hot flashes are disruptive and impact women's overall quality of life, affecting their mood and their ability to sleep. In fact, insomnia typically worsens with the severity of hot flashes.
According to the North American Menopause Society, hot flashes are the most common menopause-related discomfort. For some women, these symptoms can persist for 10 years or more. The exact cause of hot flashes is not known.
Serada is an investigational extended-release, orally administered formulation of gabapentin for the treatment of menopausal hot flashes using Depomed's proprietary Acuform drug delivery technology.
By combining gabapentin with Acuform technology, Serada is absorbed slowly into the upper gastrointestinal tract over several hours rather than immediately. Serada has not been approved by the FDA for any use at this time.
DEPO closed Tuesday's regular trading up 3.97% at $6.29. The stock has been trading between $4.20 and $9.26 for the past 52 weeks.