First Non-Hormonal Hot Flash Drugs Could Clear FDA Panel In March
This article was originally published in The Pink Sheet Daily
Depomed’s gabapentin and Noven Pharmaceuticals’ paroxetine to get advisory committee review for a menopausal hot flash indication; while Phase III data for both drugs are positive, certain endpoints did not reach statistical significance in at least one study.
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Advisory Committee for Reproductive Health Drugs will consider efficacy of Depomed’s and Noven Therapeutics’ vasomotor symptom treatments, but both had problems maintaining their effects at week 12 of clinical trials.
Despite the product’s rocky history, Depomed says it is ready to file its non-hormonal hot flash treatment Serada (extended-release gabapentin) based on a recent meeting with FDA. But a mixed Phase III dataset raises doubts about approvability.
Building a stable of next-generation women's health products is not coming easily to Wyeth. The drug maker received an "approvable" letter July 23 for its Effexor XR follow-on Pristiq for treatment of vasomotor symptoms of menopause, including night sweats and hot flashes