FDA issues reasons behind contraceptive patch review denial.
The CRL was issued 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 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 III 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.
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 26 December 2017.
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