BioCentury
ARTICLE | Company News

Agile gets second CRL for Twirla

December 22, 2017 8:33 PM UTC

Agile Therapeutics Inc. (NASDAQ:AGRX) was off $2.24 (47%) to $2.52 on Friday after FDA issued a second complete response letter for Twirla (AG200-15), its once-weekly transdermal contraceptive patch. Agile said the CRL "identifies deficiencies relating to quality adhesion test methods," questions Twirla's in vivo adhesion properties and asked the company to resolve third-party manufacturing concerns.

In 2013, FDA issued its first CRL for Twirla, requesting an additional clinical trial and information on Twirla's manufacturing process...

BCIQ Company Profiles

Agile Therapeutics Inc.