{"id":1674,"date":"2014-09-15T22:58:41","date_gmt":"2014-09-15T21:58:41","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/fda-accepts-tuzistra-xr-ccp-01-nda-for-full-review\/"},"modified":"2023-08-23T14:56:20","modified_gmt":"2023-08-23T13:56:20","slug":"fda-accepts-tuzistra-xr-ccp-01-nda-for-full-review","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/fda-accepts-tuzistra-xr-ccp-01-nda-for-full-review\/","title":{"rendered":"FDA accepts Tuzistra\u2122 XR (CCP-01) NDA for full review"},"content":{"rendered":"
\u00a0 \u00a0 <\/p>\n
MONMOUTH JUNCTION, N.J., September 15, 2014; –<\/p>\n
Vernalis plc and Tris Pharma, Inc. (“Tris”) are pleased to announce that the U.S. Food and Drug Administration (“FDA”) has confirmed that the New Drug Application (“NDA”) for Tuzistra\u2122<\/sup> XR (“CCP-01”) has been accepted for full review. This triggers a milestone payment from Vernalis to Tris.<\/p>\n The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015.<\/p>\n Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. Tuzistra\u2122<\/sup> XR represents the first product within this pipeline to reach NDA stage. The financial terms of this licensing deal are not disclosed.<\/p>\n Ian Garland, CEO of Vernalis commented “Today\u2019s announcement is in line with our target timelines and importantly Tuzistra\u2122<\/sup> XR remains on-track for potential launch ahead of the 2015-16 cough cold season.”<\/p>\n Ketan Mehta, CEO of Tris commented, “FDA’s acceptance of this NDA submission provides further momentum to our collective cough\/cold strategy, with a focus on improving patient care.”<\/p>\n About Tris Pharma:<\/u><\/strong><\/p>\n Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable\/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, USA. For more information, please visit\u00a0https:\/\/www.trispharma.com<\/a><\/p>\n About Vernalis:<\/u><\/strong><\/p>\n Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in drug development. The Group has one marketed product, frovatriptan for the acute treatment of migraine, an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough cold market as well as seven programmes in its NCE development pipeline. Vernalis has also significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies. The Company\u2019s technologies, capabilities and products have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including AKP, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier and Tris.<\/p>\n