Vernalis completes CCP-07 single-dose comparative bioavailability study

CCP-07 is the second product being developed for Vernalis by Tris Pharma Inc ("Tris") for the US prescription cough cold market. The first product, TuzistraXR was approved by the FDA in April 2015 and was launched by Vernalis in September 2015, through a dedicated sales force.

CCP-07 will now move into a multiple-dose comparative bioavailability study and continues in 12-month stability studies. Subject to the successful outcome of these studies, filing of the NDA for CCP-07 with the FDA remains on track for 2016.

Under the licensing and development collaboration announced on 10 February 2012, Vernalis is paying Tris to develop up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments.

Vernalis CEO Ian Garland said: "We are delighted with the continued progress of CCP-07 which further demonstrates the low-development risk of our cough cold pipeline in development with Tris, and we look forward to further news flow from these programmes, over the coming months."