- Industry watchers looking for proof of the Food and Drug Administration's regulatory flexibility have another piece of evidence to point to after the agency agreed to review TherapeuticsMD Inc.'s vaginal pain drug without an additional pre-approval study.
- According to TherapeuticsMD, the FDA said it would drop its previous demand for a 12-month safety trial for TX-004HR, agreeing to a resubmission of the Florida company's New Drug Application in an in-person meeting earlier this month.
- Instead, TherapeuticsMD will now need to conduct a post-approval observational study, clearing the path for a filing within "the coming weeks."
The FDA rejected TX-004HR in May, issuing the company a complete response letter that requested additional endometrial safety data. Shares in the company sank on the setback, which would likely have delayed TX-004HR's path to market by more than a year and required additional investment.
But that was before Scott Gottlieb became FDA Commissioner, bringing with him a desire to make the agency more flexible and responsive. Since then, the agency has gone back on previous demands for additional data on experimental drugs from Eli Lilly & Co. and Amicus Therapeutics Inc.
Such willingness to speed drugs to market has its critics. Even so, the FDA's newfound flexibility does appear to have limits. Last month, the regulatory flatly rejected PTC Therapeutics Inc.'s treatment for Duchenne muscular dystrophy (DMD) after an independent advisory panel concluded there wasn't enough evidence to proove the drug worked as intended.
PTC had tried to win over the FDA for months and the company's case appeared to be boosted by another controversial approval in DMD last year.
For TherapeuticsMD, the FDA's decision to wave an NDA resubmission back through bodes well, although the regulator could still end up rejecting TX-004HR. Given the concerns on safety, perhaps a more likely outcome would be requiring the drug to carry a black box warning or other caution.
TX-004HR is designed to treat moderate-to-severe vaginal pain during sexual intercourse, a condition known as dyspareunia and a symptom of vulvar and vaginal atrophy due to menopause.