Depomed Comments On FDA Guidance And Plans For One Additional Phase 3 Clinical Trial Evaluating Non-Hormonal Therapy For Menopausal Hot Flashes
Depomed, Inc. (NASDAQ:DEPO) announced it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company's extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes. The company expects to initiate the trial, which will be known as Breeze 3, by the end of April 2010 and to complete the trial by the end of the first quarter of 2011. The FDA has agreed to review the proposed Breeze 3 study protocol under the FDA's Special Protocol Assessment (SPA) process.
"We believe Serada continues to hold the potential to be the first non-hormonal treatment to address menopausal hot flashes, a significant unmet need in women's health," said Michael Sweeney, M.D., Depomed's vice president, Research and Development.
Carl A. Pelzel, president and chief executive officer of Depomed, added, "We are pleased with the outcome of our recent meeting with the FDA. We believe the refinements made to the design of Breeze 3 will provide for a robust trial to evaluate the efficacy of Serada."
Breeze 3 Trial Design
Breeze 3 will be a randomized, double-blind, placebo-controlled study of up to 600 patients. Patients will be randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada dosed 600mg in the morning and 1200mg in the evening. The co-primary efficacy endpoints in the study will be reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after four and 12 weeks of stable treatment. As in the prior Breeze 1 trial, the treatment duration of the study will be 24 weeks, to address the FDA's view that an effective drug should also show statistically significant persistence of efficacy at 24 weeks. The trial will also include a responder analysis to assess the clinical meaningfulness of any reduction in the frequency of hot flashes in the active arm relative to the placebo arm.
Modifications to the design of Breeze 3 relative to Breeze 1 and 2 include: (i) a single active arm rather than two arms, and therefore a required statistical p value of .05 rather than .025 to achieve statistical significance; (ii) up to 65% more patients in the active treatment arm than in (iii) a two-week run in period to prior to randomization, rather than one week, which is designed to reduce the regression to the mean observed in Breeze 1 and 2, resulting in a more stable baseline, and thereby potentially reducing the placebo effect; and (iv) an alternative statistical analysis method, known as a non-parametric analysis, that is designed to reduce the influence significant outliers can have on the achievement of efficacy endpoints.
Special Protocol Assessment
Depomed plans to submit the proposed Breeze 3 study protocol under the FDA's Special Protocol Assessment (SPA) process by the end of January 2010. An SPA is an agreement with the FDA that a proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support a product candidate's regulatory approval.
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® 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.
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