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PharmaNova’s U.S. Licensee and Partner for Menopause Treatment, Depomed, Inc. Starts Final Phase 3 Hot Flash Trial Enrollment after SPA Agreement with FDA.

PharmaNova’s U.S. Licensee and Partner for Menopause Treatment, Depomed, Inc. Starts Final Phase 3 Hot Flash Trial Enrollment after SPA Agreement with FDA.   


PharmaNova, Inc. of Victor, New York announced today that its US licensee and development partner, Depomed, Inc. (DEPO Nasdaq) reached agreement with FDA on the design and analysis of their Breeze 3 clinical trial protocol under FDA’s Special Protocol Assessment (SPA)  process.  Breeze 3 is the final pivotal trial evaluating Serada™, an extended release gabapentin formulation for the treatment of menopausal hot flashes.   This action results in the immediate start of the Breeze 3 trial. Multiple US sites are fully prepared, awaiting recruitment of more than 200 patients already in the screening process.  Anticipated trial completion is end of 3Q2011.


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.


About PharmaNova

* 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 in-house 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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