Depomed Reports Results From Two Phase 3 Clinical Trials Evaluating Non-Hormonal Therapy for Menopausal Hot Flashes
MENLO PARK, Calif., Oct 12, 2009 -- Depomed, Inc. (NASDAQ:DEPO) announced today top-line results from the BREEZE 1 and 2 Phase 3 clinical trials evaluating the safety and efficacy of SeradaTM, an investigational non-hormonal extended release formulation of gabapentin for the treatment of menopausal hot flashes.
In the higher dose treatment arm of the two doses evaluated, the 1800mg dose achieved positive results at 4 weeks. All four co-primary endpoints of the 1800mg dose at 4 weeks demonstrated significant reductions in frequency and severity in both clinical trials (p-values ranged from 0.0001 to 0.004). Of the other four co-primary endpoints of the 1800mg dose at 12 weeks, one endpoint was positive (p=0.0026) while the other three endpoints did not achieve statistical significance.
In the lower dose treatment arm, the 1200mg dose at 4 weeks achieved statistical significance in three of the four co-primary endpoints. Frequency was significantly reduced in both clinical trials (p-values of 0.0024 and 0.0117) at four weeks. Severity was significantly reduced in only one trial (p-value 0.0016). Of the other four co-primary endpoints of the 1200mg dose at 12 weeks, one endpoint was positive (p=0.0024) while the other three endpoints did not achieve statistical significance.
The primary endpoints in the studies were a statistically significant reduction in the frequency and severity of menopausal hot flashes relative to placebo after 4 weeks and 12 weeks of stable treatment. Both patients' and clinicians' impression of overall improvement in the higher dose treatment arm was highly statistically significant relative to placebo in both studies.
Additional efficacy and safety details will be provided on Depomed's investor conference call scheduled for today, October 12, 2009.
"We remain very enthusiastic about Serada and our menopausal hot flash program. There is a large unmet need for a non-hormonal hot flash therapy, and we believe Serada has the potential to address that need," said Carl Pelzel, Depomed's president and chief executive officer. "We look forward to meeting with the FDA later this quarter to discuss these results, the path to approval and any additional clinical work that may be required."
"We are pleased to see that the 1800mg dose clearly demonstrated Serada's efficacy at 4 weeks while the lower 1200mg dose at 4 weeks achieved three of the four co-primary endpoints. While the drug effect in the studies was what we expected to see, there was an unexpectedly high placebo effect, particularly in the latter part of one of the studies," said Dr. Michael Sweeney, M.D., Depomed's vice president, Research and Development. "We need to extensively analyze the data to better understand all of the implications in order to refine our approach to any additional development."
In each BREEZE study, patients were randomized into three treatment arms: placebo; Serada 1200mg dosed once daily; or Serada 1800mg twice daily (dosed 600mg in the morning and 1200mg in the evening). BREEZE 1 and 2 combined enrolled 1,100 patients. The four co-primary efficacy endpoints in both studies were the reductions in the mean frequency of moderate to severe hot flashes, and the average severity of hot flashes, measured after four weeks and 12 weeks of stable treatment. Patients in the BREEZE 2 study received twelve weeks of treatment, while patients in the BREEZE 1 study were treated for six months in order to assess safety and persistence of efficacy.
Serada was generally well tolerated in both BREEZE trials. The most common adverse events were dizziness and somnolence. The incidence of dizziness in the active arms was between 17% and 24% (compared to 3% for placebo). Somnolence ranged from 7% to 19% in the active arms (compared to 2% or 3% in the placebo arms).
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.
Serada is an extended-release 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. Immediate release formulations of gabapentin have been approved by the FDA to treat neuropathic pain and epilepsy.
Investor Conference Call
Depomed will host a conference call today, October 12, 2009, beginning at 9:00 a.m. ET, 6:00 a.m. PT to discuss the results of the trials in further detail. The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. 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.
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 Solvay Pharmaceuticals. A New Drug Applications for DM-1796 is expected to be filed with the FDA in the first quarter of 2010. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA(R) (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(R) 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, 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.