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PHARMANOVA’S LICENSEE INITIATES PHASE 3 CLINICAL PROGRAM FOR NON-HORMONAL MENOPAUSAL HOT FLASH TREATMENT
PharmaNova’s licensee, Depomed, Inc., announced today the initiation of the first of two pivotal Phase 3 clinical trials for Gabapentin-GR®, a proprietary formulation of gabapentin being developed for the US market for the treatment of menopausal hot flashes.
The enrollment and dosing of the first patient in Breeze 1 (the first of two pivotal Phase 3 clinical trials for US FDA regulatory submission) is underway. This novel treatment for menopausal hot flashes could be the first non-hormonal, non-antidepressant, single-agent available in the US to treat menopausal hot flashes.
The treatment duration of Breeze 1 will be six months, with primary efficacy endpoints assessed at 4 and 12 weeks. Persistence of efficacy will be assessed at 6 months as one of the secondary endpoints. The treatment duration of Breeze 2 will be three months with assessment of efficacy at 4 and 12 weeks only. Breeze 2 is expected to commence by the end of 2008.
Rodney Brown, President of PharmaNova said “We are delighted with and congratulate our partners, Depomed, on their progress in advancing this important program. Following the excellent outcomes of the Phase 2 studies completed earlier this year, we anticipate that gabapentin-GR® could be a first in class, first to market, non-hormonal Rx treatment for menopausal hot flashes.”
PharmaNova holds the exclusive rights to IP for use of gabapentin to treat vasomotor symptoms (VMS, hot flashes) of menopause and the VMS side effects of treatments for breast and prostate cancers. These rights are available for license in Europe and other ex-US territories.
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