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|Depomed Announces Top-Line Results From Serada(R) Phase 3 Trial BREEZE 3 in Menopausal Hot Flashes|
MENLO PARK, Calif., Oct 13, 2011 (GlobeNewswire via COMTEX) --
Depomed, Inc. (Nasdaq:DEPO) today announced top-line results from BREEZE 3, a Phase 3 trial evaluating the efficacy and safety of Serada(R) (extended-release gabapentin tablets) for menopausal hot flashes. Serada is a proprietary formulation of gabapentin using patented polymer technology that enables gradual release of the drug.
Efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks. Data for the key secondary endpoints of frequency and severity at 24 weeks did not achieve statistical significance. Safety results showed that Serada was well-tolerated. Based on these results, and combined with the data from prior BREEZE 1 and 2 Phase 3 trials, Depomed intends to review the results with the United States Food and Drug Administration (FDA) and discuss possible pathways to filing a new drug application (NDA).
Jim Schoeneck, Depomed president and chief executive officer, commented: "We believe the data are sufficient to warrant discussion with the agency. We continue to believe Serada can offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes. With the recent launch of Gralise(R) to treat postherpetic neuralgia (PHN), and as we continue to pursue our Serada strategy, we are well positioned to become a significant player in the specialty pharmaceutical arena."
BREEZE 3 Trial Design and Results
BREEZE 3 is a randomized, double-blind, placebo-controlled study of 600 women. Subjects were randomized into one of two treatment arms, with women receiving either placebo or a total dose of 1800mg of Serada dosed at 600mg in the morning and 1200mg in the evening.
The co-primary efficacy endpoints in the study were reductions in the average daily frequency and severity of moderate-to-severe hot flashes, measured after four and 12 weeks of treatment using a non-parametric statistical analysis. The treatment duration of the study was 24 weeks.
The primary severity endpoints were achieved with statistical significance at four weeks (p < 0.001) and 12 weeks (p < 0.01). The frequency endpoint at four weeks was achieved with statistical significance (p < 0.001). The frequency endpoint at 12 weeks, as well the key secondary frequency and severity endpoints at 24 weeks, were not met.
Serada was generally well tolerated in BREEZE 3. The most common adverse events were dizziness and somnolence. The incidence of dizziness in the active arm was 12.7% compared to 3.4% for the placebo arm. Somnolence was 6.0% in the active arm compared to 2.7% in the placebo arm. Withdrawals due to adverse events in the active arm were 17%, compared to 12% in the placebo arm.
Conference Call Today
Depomed will host a conference call today, October 13, 2011, beginning at 5:00 p.m. ET, 2:00 p.m. PT to discuss the Serada BREEZE 3 data. The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com.
The dial-in number for the conference call is 888-219-1459 and the passcode is 6345726. For the webcast, please access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the company's website for three months.
About Menopausal Hot Flashes
Hot flashes affect 75% 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. 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 products on the market. 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 commercialized by Santarus, Inc. in the United States. The company also has a robust pipeline including Serada(R), which is in Phase 3 clinical development for menopausal hot flashes, as well as earlier stage candidates. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology. 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.
Statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements related to the prospects of regulatory approval for Serada or the company's future business prospects. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. The achievement of those plans and objectives involves risks and uncertainties including, but not limited to, risks and uncertainties related to results of clinical trials and other research and development efforts; 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.
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SOURCE: Depomed, Inc.