CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma for the US prescription cough-cold market.
The first product, Tuzistra XR was approved by the FDA in April 2015 and was launched by Vernalis in September 2015, through a focused US primary care sales force.
CCP-08 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-08 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-08 and look forward to further news flow from this programme during 2016".