MENLO PARK, CA--(Marketwire - October 07, 2010) - Depomed, Inc. (NASDAQ: DEPO) today announced presentations of clinical data of Breeze 1 and 2 at the North American Menopause Society (NAMS) Annual Meeting in Chicago, Illinois on October 8, 2010. Both Breeze 1 and 2 are Phase 3 trials that evaluated Serada® (extended release gabapentin tablets) for menopausal hot flashes.
The titles of the two presentations are: “The Effect of Outliers on Hot Flash Frequency in the Breeze 1 Study of Gabapentin-ER for the Non-Hormonal Treatment of Vasomotor Symptoms”, and “Effect of Gabapentin Extended-Release (G-ER) on Hot Flashes in Post-Menopausal Women - Breeze 2 Study”.
The two slide presentations will be available on Depomed’s investor relations website following the presentation.
“We are pleased that our two presentations of data from both our Breeze 1 and 2 studies had been accepted for oral presentations at NAMS,” noted Dr. Michael Sweeney, Depomed’s vice president, research & development. “With Breeze 3 currently enrolling under an SPA with the FDA we believe that we will successfully advance our hot flash program.”
About Menopausal Hot Flashes
Hot flashes, which affect 32 million women in the U.S. annually, are characterized by a sudden, temporary onset of body warmth, flushing and sweating. 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. Research suggests hot flashes occur when the body’s internal thermoregulatory mechanism (located in the hypothalamus) becomes irregular, narrowing the body’s thermoneutral zone. Thus, even small fluctuations in body temperature can cause menopausal women to experience perfuse sweating or severe chills that would not affect a person with a properly functioning thermoregulatory mechanism.
About Serada
Serada is an extended-release 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. Immediate release formulations of gabapentin have been approved by the FDA to treat neuropathic pain and epilepsy.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Abbott Products Inc. A New Drug Application for DM-1796 was accepted by the FDA in the second quarter of 2010. Product candidate Serada® is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, http://www.depomed.com.
“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 Serada and potential benefits of Serada; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. 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.
CONTACT:
Sheilah Serradell
Depomed, Inc.
650-462-5900
sserradell@depomed.com
