BioCentury
ARTICLE | Clinical News

Agile gets second CRL for Twirla

January 5, 2018 5:38 PM UTC

Agile Therapeutics Inc. (NASDAQ:AGRX) said on Dec. 22, 2017, that FDA issued a second complete response letter for Twirla (AG200-15), a 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.

The first CRL, issued in 2013, requested an additional clinical trial and information on Twirla's manufacturing process...