Depomed Hot Flash Drug May Finally Be On Its Way To FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Depomed Eyes More Acquisitions With PDL Royalty Sale Cash
The specialty pharma plans additional purchases that fit into its growing pain and neurology portfolio, after a late-stage failure in women’s health. With the cash infusion, it may make bigger deals than before.
Placebo Effect Raises Questions About Clinical Value For Depomed, Noven Hot Flash Treatments
Advisory Committee for Reproductive Health Drugs asks whether FDA standards are too difficult to meet for non-hormonal products like gabapentin and paroxetine after the placebo arms of both drugs’ trials show a strong reduction in vasomotor symptoms.
Gabapentin Cannot Navigate Efficacy Hurdles At Advisory Committee
FDA Advisory Committee on Reproductive Health Drugs votes overwhelmingly against recommending approval of new indication for severe to moderate vasomotor symptoms, saying the modest effect shown was not sufficient.