Nicox announced the resubmission of 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 brand name provisionally approved by the FDA for AC-170 is Zerviate.
Nicox received confirmation that the FDA’s Current Good Manufacturing Practice (CGMP) concerns surrounding the production site of the active pharmaceutical ingredient (API), cetirizine, have been resolved, and the company subsequently updated and resubmitted the Zerviate (cetirizine ophthalmic solution) 0.24% NDA to the FDA. Once resubmitted, the FDA has 30 days to acknowledge its receipt, state the classification, and provide the due date for action, with a maximum review period of 6 months if the resubmission is a Class 2 resubmission.
"Resolution of the FDA's concerns surrounding the API manufacturing site is excellent news for Nicox, allowing us to resubmit the NDA for a potential approval before the end of 2017," Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in the news release. “Our go-to-market strategy for Zerviate is to secure a commercialization partner in the US, and this opportunity has already generated interest from several parties, with discussions ongoing involving key industry players active in both eye care and general practitioner segments. Together with latanoprostene bunod (VYZULTA3), which, subject to FDA approval, our partner Bausch + Lomb expects to launch into the US market in the second half of 2017, this gives Nicox two potential revenue generating assets approved in 2017 to support our growth and the development of our value-creating pipeline.”
In October 2016, Nicox announced the receipt of a complete response letter (CRL) from the FDA in response to the Zerviate NDA. The FDA’s stated reason for the CRL pertained solely to a CGMP inspection at a third party facility producing the API, cetirizine, and supplying it to the manufacturer of the finished product. The safety and efficacy data submitted by Nicox in the Zerviate NDA have not resulted in the FDA requesting any further clinical or nonclinical testing for the approval of the Zerviate NDA. Furthermore, the CRL did not include any concerns related to the finished product manufacturing facility.