Agile Therapeutics Inc (NASDAQ:AGRX) reported that the U.S. FDA released a complete response letter in response to the NDA resubmission for the firm’s investigational hormonal contraceptive patch named Twirla (AG200-15). The refiling of the NDA, which is looking for approval for Twirla was permitted for review earlier in 2017. The PDUFA goal date was fixed as December 26, 2017. The Complete Response Letter stated that the FDA has decided that it cannot permit the NDA in its current form.
The Complete Response Letter identifies deficiencies pertaining to quality adhesion test processes. It also marked that observations noted during facility inspection of the firm’s third-party manufacturer named Corium International Inc., for the Twirla NDA had to be resolved. Moreover, the CRL focuses on in vivo adhesion properties of AG200-15 and their potential association to the SECURE Phase III clinical study data.
The CRL comprises recommendations for advancing manufacturing in-process assessments for ensuring the in vivo adhesion and quality of the commercial scale product and the finished drug specifications as well as release test process for adhesion. Agile Therapeutics reported that the Complete Response Letter also recommends that the firm evaluates the in vivo adhesion properties showcased in the SECURE clinical study. Finally, it recommends that the firm resolves the implications of clinical study subject patch compliance and the dropout and withdrawal rates. The CRL fail to identify any specific problems pertaining to the safety of Twirla.
As per the update, over the course of the review cycle, Agile Therapeutics filed a change to the NDA in anticipation to information request from the U.S. FDA on the issues pertaining to quality adhesion test procedures mentioned in the CRL. Moreover, Corium also offered the FDA responses resolving each of the observations recorded during the FDA’s inspection of the facility on November 20 and December 1, 2017.