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PharmaNova’s U.S Development and Commercial Partner, Depomed Inc., Comments on FDA Guidance and Plans for One Additional Phase 3 Clinical Trial Evaluating Non-Hormonal Therapy for Menopausal Hot Flashes Under the FDA’s Special Protocol Assessment (SPA)
PharmaNova’s U.S Development and Commercial Partner, Depomed Inc., Comments on FDA Guidance and Plans for One Additional Phase 3 Clinical Trial Evaluating Non-Hormonal Therapy for Menopausal Hot Flashes Under the FDA’s Special Protocol Assessment (SPA) Process
PharmaNova, Inc of Victor, New York announced today that Depomed Inc., PharmaNova’s development and commercial (sub)-licensee* for the United States, received guidance from the FDA on January 19, 2010 regarding one additional Phase 3 clinical trial for Serada™, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Depomed 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.
About Menopausal Hot Flashes
According to the North American Menopause Society, hot flashes are the most common menopause-related discomfort for over 32 million women in the U.S. and represents a significant unmet need in women’s health.
Special Protocol Assessment
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.
* PharmaNova owns the exclusive worldwide rights to the use and commercialization of gabapentin for the treatment of hot flashes and to certain other vasomotor conditions including the alleviation of hot flash VMS associated with e.g. breast cancer and prostate cancer. Depomed’s use of Serada™ for treatment of menopause hot flashes is under sub-license from PharmaNova, and for commercialization solely in the U.S.
European (EU), Canadian, Australian, and New Zealand rights to the use of gabapentin for hot flash vasomotor indications are retained exclusively by PharmaNova and are available for Licensing/Partnering/Commercialization.
PharmaNova Inc. is a privately held pharmaceutical company. Our product candidates are derived from the re‐positioning and enhancement of known drugs using our proprietary NovaSperse℠ nanoparticle technology platform. We address low risk, fast to market products in areas of clear medical need and generate revenue from partnering and licensing strategies with commercialization partners and clients worldwide. PharmaNova also conducts contractual formulation development work applying NovaSperse℠ technology to client‐owned products and compounds to support new product development or the extended life cycle management of existing products. Independently of Serada™, in late Phase 3 clinical development, PharmaNova has other new product candidates in various stages in its development pipeline. Our focus is on the development of novel, improved nanoparticle formulations of ophthalmic and anti-infective products.
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