Vernalis PLC Announces Successful Completion Of CCP-07 Pivotal Multiple-Dose Comparative Bioavailability Study
CCP-07 NDA filing remains on track for 2016
Vernalis plc ("Vernalis" or the "Company") today announces successful completion of the CCP-07 pivotal multiple-dose comparative bioavailability study.
CCP-07 is the second extended-release product being developed for Vernalis by Tris Pharma Inc. ("Tris") 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 third product, CCP-08, recently completed its pivotal single-dose comparative bioavailability study.
CCP-07 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.
Ian Garland, CEO of Vernalis commented "We are delighted with the successful completion of CCP-07 pivotal bioavailability studies and look forward to further news flow from this programme in 2016".
Vernalis plc ("Vernalis" or the "Company") today announces successful completion of the CCP-07 pivotal multiple-dose comparative bioavailability study.
CCP-07 is the second extended-release product being developed for Vernalis by Tris Pharma Inc. ("Tris") 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 third product, CCP-08, recently completed its pivotal single-dose comparative bioavailability study.
CCP-07 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.
Ian Garland, CEO of Vernalis commented "We are delighted with the successful completion of CCP-07 pivotal bioavailability studies and look forward to further news flow from this programme in 2016".