SefelsaTreatment for Menopausal Hot Flashes
Depomed Announces Intent to File NDA for Serada for Treatment of Menopausal Hot Flashes
MENLO PARK, Calif., Apr 17, 2012 -- Depomed, Inc. today announced that it has completed a Type B pre-NDA meeting with the United States Food and Drug Administration (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 results of the meeting with the FDA, Depomed intends to prepare and file a new drug application with the FDA in the second half of 2012.
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.
"Based on our recent interactions, we believe that data from our Serada clinical trial program warrants submission of an NDA for the FDA's review and consideration," said Jim Schoeneck, president and chief executive officer of Depomed. "We believe Serada may offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes."
About Menopausal Hot Flashes
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. 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(R) 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.
Depomed, Inc. is a specialty pharmaceutical company with two approved and marketed products. Gralise(TM) (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Glumetza(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the potential benefits of Serada; the uncertainty of achieving regulatory approval to market Serada; the uncertainty that if approved, Serada can be successfully commercialized; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Depomed, Inc.
CONTACT: August J. Moretti
Posted: April 2012
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