“Hot Flash” Persistence At Week 12 Suggests Cool Reception For Products At FDA Cmte
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
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.
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.