Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla®

Agile Therapeutics (NASDAQ:AGRX) has announced that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) submission for Twirla, a combined hormonal contraceptive patch.

As quoted in the press release:

The NDA resubmission was submitted on May 16, 2019 and is intended to address a Complete Response Letter (CRL) issued by the FDA in December 2017, 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. The FDA stated that it considers the resubmission to be a complete, class 2 response to the CRL and established November 16, 2019 as the Prescription Drug User Fee Act (PDUFA) goal date.

“The acceptance of our NDA for review represents a significant milestone for Agile. Now that the FDA has acknowledged our NDA resubmission as a complete response to the CRL, we look forward to continuing to work with the FDA during their review,” said Al Altomari, Chairman and Chief Executive Officer of Agile.

Click here to read the full press release.