06 Apr 2009 05:00 AM
Depomed Completes Enrollment Of Serada's Full Phase 3 Clinical Program In Menopausal Hot Flashes
Depomed, Inc. (NASDAQ:DEPO) announced that it has completed enrollment of Breeze 2, the second of two pivotal Phase 3 clinical trials of SeradaTM (formerly referred to as DM-5689) for the treatment of menopausal hot flashes.
"I would like to thank all clinical investigators, patients, and Depomed employees whose efforts allowed us to complete enrollment of our full Phase 3 clinical program for Serada. We are encouraged by the level of interest in a non-hormonal alternative treatment for menopausal hot flashes that we noticed during the recruitment of patients. This confirms that there is a significant unmet need existing in the marketplace. We look forward to the results of both of Serada's trials in hot flashes - Breeze 1 and Breeze 2 - which we expect in the fourth quarter of this year," said Carl A. Pelzel, president and chief executive officer of Depomed.
"I am glad to see that Serada is advancing well to potentially become a significant alternative non-hormonal treatment of hot flashes. Physicians and patients are looking for alternatives to today's broadly used hormone replacement therapy and Serada could well address those needs. After having seen Depomed's encouraging Phase 2 results, we look forward to the Phase 3 results later this year," added Wulf Utian, MD PhD DSc, Executive Director and Founder of The North American Menopause Society (NAMS), and Consultant in Women's Health to The Cleveland Clinic. Dr. Utian is also the lead investigator in the Breeze 2 trial.
About Serada's Clinical Program
Depomed's Phase 3 registration program for Serada in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study. The treatment duration of the Breeze 1 study is six months, with primary efficacy endpoints assessed after 4 and 12 weeks of stable treatment…
"I would like to thank all clinical investigators, patients, and Depomed employees whose efforts allowed us to complete enrollment of our full Phase 3 clinical program for Serada. We are encouraged by the level of interest in a non-hormonal alternative treatment for menopausal hot flashes that we noticed during the recruitment of patients. This confirms that there is a significant unmet need existing in the marketplace. We look forward to the results of both of Serada's trials in hot flashes - Breeze 1 and Breeze 2 - which we expect in the fourth quarter of this year," said Carl A. Pelzel, president and chief executive officer of Depomed.
"I am glad to see that Serada is advancing well to potentially become a significant alternative non-hormonal treatment of hot flashes. Physicians and patients are looking for alternatives to today's broadly used hormone replacement therapy and Serada could well address those needs. After having seen Depomed's encouraging Phase 2 results, we look forward to the Phase 3 results later this year," added Wulf Utian, MD PhD DSc, Executive Director and Founder of The North American Menopause Society (NAMS), and Consultant in Women's Health to The Cleveland Clinic. Dr. Utian is also the lead investigator in the Breeze 2 trial.
About Serada's Clinical Program
Depomed's Phase 3 registration program for Serada in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study. The treatment duration of the Breeze 1 study is six months, with primary efficacy endpoints assessed after 4 and 12 weeks of stable treatment…
