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Agile Therapeutics, Inc. receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the prevention of pregnancy.

Agile Therapeutics, Inc., a women’s healthcare company, announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in response to the New Drug Application (NDA) resubmission for the company’s investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15).

The resubmission of the NDA, which is seeking approval for Twirla was accepted for review earlier this year. The Prescription Drug User Fee Act (PDUFA) goal date was December 26, 2017. The CRL states that the FDA has determined that it cannot approve the NDA in its present form.

The CRL identifies deficiencies relating to quality adhesion test methods. The CRL also noted that observations identified during an inspection of a facility of the company’s third-party manufacturer, Corium International Inc., (Corium), for the Twirla NDA must be resolved. 

Lastly, the CRL questions the in vivo adhesion properties of Twirla and their potential relationship to the SECURE phase 3 clinical trial results.

The CRL contains recommendations for developing manufacturing in-process tests for ensuring the quality and in vivo adhesion of the commercial scale product as well as the finished drug specifications and release test method for adhesion. The CRL also recommends that the company assess the in vivo adhesion properties demonstrated in the SECURE clinical trial.

Finally, the CRL recommends that the company address the implications of clinical trial subject patch compliance and the withdrawal and dropout rates. The CRL does not identify any specific issues relating to the safety of Twirla.

During the review cycle, the company submitted an amendment to the NDA in response to an information request from the FDA on the issues related to quality adhesion test methods cited in the CRL. In addition, Corium also provided the FDA responses addressing each of the observations made during the FDA’s facility inspection on November 20, 2017 and December 1, 2017. 

The CRL acknowledges receipt of the company’s NDA amendment submitted on December 1, 2017, and states that the amendment was not reviewed prior to the FDA’s action. The FDA indicated that applicable sections of the amendment submitted by Agile could be incorporated when responding to deficiencies noted in the CRL.
     
“We are clearly disappointed, and we are evaluating the FDA’s response,” said Al Altomari, chairman and chief executive officer, Agile Therapeutics. “We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and discuss a path to approval for Twirla. We will work closely with the FDA to address the points raised in the CRL as quickly as possible.”

(Source: Agile Therapeutics, Inc.)

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