Regulatory Affairs

FDA rejects Vernalis’ NDA for cough cold treatment

PBR Staff Writer Published 24 April 2017

The US Food and Drug Administration (FDA) has rejected Vernalis’ new drug application for cough cold treatment, CCP-07.

CCP-07, which is being developed by Tris Pharma, is a cough-cold formulation being developed for the US prescription cough-cold market.

The FDA issued complete response letter (CRL) for CCP-07, which included the questions that must be addressed to consider for approval.

Vernalis said the CRL did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07 but did identify outstanding items that required to be addressed before resubmission and approval of the NDA.

Vernalis and Tris Pharma’s NDA was accepted by FDA in September 2016 for full review of CCP-07.

As part of exclusive licensing and collaboration agreement announced in February 2012, Tris agreed to develop up to six extended release equivalents to existing immediate release prescription cough cold treatments for the US market.

CCP-07 is the second product from the pipeline, which was accepted for full NDA review.

Vernalis CEO Ian Garland said: "We remain committed to the approval of CCP-07 and will work closely with the FDA to resubmit the NDA as quickly as possible.”

In April 2015, the FDA had approved first product Tuzistra XR cough cold treatment for the US market.

Vernalis and Tris Pharma secured approval from the FDA for NDA for Tuzistra extended-release oral suspension, CIII (DEA Schedule III) for relief of cough in adults aged 18 years and older.

Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine indicated for oral use for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults.

Image: The FDA campus New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.