Agile Therapeutics announces results of its pre-submission meeting with FDA

|About: Agile Therapeutics, Inc. (AGRX)|By:, SA News Editor

Agile Therapeutics (NASDAQ:AGRX) announces it has received the final meeting minutes from its recent New Drug Application (NDA) pre-submission meeting with the FDA for its lead product candidate, Twirla, an investigational low-dose combined hormonal contraceptive patch.

The Company reported top-line results from its Phase 3 SECURE clinical trial and plans to resubmit its NDA for Twirla by the end of Q2.

The FDA indicated that based on the preliminary information provided by the Company, the SECURE trial results appear acceptable for resubmission. The FDA provided responses to the Company regarding the presentation of efficacy, safety and clinical pharmacology analyses in the NDA and requested that subgroup analysis of efficacy by body weight be provided.