Nicox announced that the FDA has set a PDUFA date of September 8, 2017 for its decision on the new drug application (NDA) for Zerviate (cetirizine ophthalmic solution) 0.24%, Nicox's novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.
"The FDA's acknowledgement regarding the completeness of the NDA resubmission for Zerviate and the assignment of a PDUFA goal date of September 8, 2017 are important milestones for Nicox," Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release. "Together with the August 24, 2017 PDUFA goal date for Vyzulta, licensed to Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International), we now await two approval decisions from FDA during the next 6 months for our lead programs, both of which are expected to be sources of significant recurrent revenue for the company. For Zerviate, we will continue to work closely with the FDA toward an approval decision in September, and advance our partnering discussions for US commercialization rights which are already underway."
Nicox resubmitted the NDA for Zerviate on March 8, 2017, in reply to a complete response letter (CRL) received from the FDA in October 2016. The FDA's stated reason for the CRL pertained solely to a CGMP inspection at a third party facility producing the active pharmaceutical ingredient, cetirizine, and supplying it to the manufacturer of the finished product. The FDA's Current Good Manufacturing Practice (CGMP) concerns surrounding the production site of the active pharmaceutical ingredient, cetirizine, have been resolved. 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.