Date: 2015-12-21
Type of information: Completion of the trial
phase:
Announcement: completion of the trial
Company: Vernalis (UK)
Product: CCP-07
Action mechanism:
Disease: cough
Therapeutic area: Respiratory diseases
Country:
Trial details:
Latest
news: * On December 21, 2015, Vernalis announced successful completion of the CCP-07 Pivotal Single-Dose comparative bioavailability study. CCP-07 is the second 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 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.
* On June 11, 2015, Vernalis announced that its partner, Tris Pharma, has successfully manufactured 3 registration batches of CCP-07 and material from these batches is now up on stability. The CCP-07 NDA submission will include 12 months of stability data and so Tris now anticipates the filing with the FDA to occur during 2016. Further news flow will follow the completion of the pivotal single-dose and multi-dose bioavailability studies anticipated to take place between now and NDA filing.
