Vernalis has today announced the completion of the CCP-08 pivotal multiple-dose comparative bioavailability study.
In the its Friday press release, the company said that CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma Inc. 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. The second product, CCP-07, completed its pivotal multi-dose comparative bioavailability study in April 2016.
The company further noted that CCP-08 continues in 12-month stability studies and subject to the successful outcome of these studies, filing of the NDA 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, the Vernalis’ press release reads.
Ian Garland, CEO of Vernalis commented “We are delighted to report the successful completion of the CCP-08 pivotal bioavailability studies and look forward to further news flow from this programme and others in our prescription long-acting cough cold product pipeline later in 2016. We remain excited by the potential for our emerging franchise in the US following the launch of the first product, Tuzistra XR, last year.”