The US Food and Drug Administration has rejected Vernalis’ cough cold treatment CCP-08, which is being developed by US partner Tris Pharma.
Tris is developing up to six unique extended release equivalents to existing immediate release prescription cough cold treatments for the US market under an exclusive licensing and collaboration agreement signed with Vernalis back in February 2012.
CCP-08 is the third product from this pipeline under review by the US Food and Drug Administration.
The first product, Tuzistra XR, was approved by the FDA in April 2015 and was launched by Vernalis in September that year by a dedicated sales force.
The second product, CCP-07, was rejected by the regulator earlier this year. Details of the questions being asked by the FDA were not revealed, but the firm did say at the time that the CRL did not raise any concerns with the formulation or pharmacokinetic profile of the drug.
The CRL for CCP-08 indicated that the outstanding items which resulted in the CRL for CCP-07 remain and that they need to be addressed prior to the resubmission and approval of both NDAs, Vernalis said.
“Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08. The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible," said Ian Garland, the UK drugmaker’s chief executive.
“We look forward to providing additional updates on our progress with this in the coming months.”