Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch,

- May 17th, 2019

Agile Therapeutics (NASDAQ:AGRX) has announced it has resubmitted to the US Food and Drug Administration (FDA) its new drug application for its lead product candidate, Twirla. As quoted in the press release: Agile resubmitted the NDA in response to a December 2017 Complete Response Letter (CRL) from the FDA, which identified deficiencies relating to (i) … Continued

Agile Therapeutics (NASDAQ:AGRX) has announced it has resubmitted to the US Food and Drug Administration (FDA) its new drug application for its lead product candidate, Twirla.

As quoted in the press release:

Agile resubmitted the 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 vivoadhesion 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.

“We have resubmitted our NDA for Twirla as planned and look forward to working with the FDA during the review process,” said Al Altomari, Chairman and Chief Executive Officer of Agile.  “Our achievement of this milestone reflects our commitment to broadening the available contraceptive treatment options for today’s women by offering an option to women seeking methods best suited to their needs and lifestyle.  We expect the FDA to acknowledge our submission as a complete response in approximately thirty days, and at the same time provide us with a Prescription Drug User Fee Act (PDUFA) date that we anticipate will be based on a six-month review.”

Click here to read the full press release.

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