17 May 2019 - Agile Therapeutics today announced it has resubmitted to the U.S. FDA the new drug application for its lead product candidate, Twirla, an investigational low-dose combined hormonal contraceptive patch (AG200-15). 

Agile resubmitted the new drug application (NDA) in response to a December 2017 Complete Response Letter (CRL) from the FDA, which identified deficiencies relating to (i) quality control adhesion test methods for the Twirla manufacturing process, (ii) observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, and (iii) questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results. 

The resubmitted NDA includes the results from a comparative wear study that was conducted at the request of the FDA to address the FDA’s questions on in vivo adhesion, additional information on the Company’s manufacturing process, and other analyses responding to the 2017 CRL.

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