NicOx NDA for AC-170 delayed by FDA

French ophthalmic drug developer NicOx (Euronext Paris: COX) has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.

The FDA's stated reason for the CRL relates solely to a Good Manufacturing Practice (GMP) inspection at a third-party facility producing the active pharmaceutical ingredient (API) cetirizine and supplying it to the manufacturer of the finished product. The safety and efficacy data submitted by NicOx in the AC-170 NDA have not resulted in the FDA requesting any further clinical or non-clinical testing for the approval of the AC-170 NDA. Furthermore, the CRL did not include any concerns related to the finished product manufacturing facility.

Since the receipt of the CRL, NicOx has been contacting its suppliers to assess the timeline for the API manufacturer to address the FDA's concerns. Once these have been addressed, NicOx will then resubmit the AC-170 NDA.