Vernalis and Tris Pharma receive FDA approval of NDA for Tuzistra™ XR
Published on April 30, 2015
Tuzistra XR offers extended relief of cough in adults with dosing every 12 hours and marks Vernalis’ entrance into the U.S. Prescription Cough Cold Market (codeine polistirex and chlorpheniramine polistirex)
MONMOUTH JUNCTION, N.J., May 1, 2015; –
Vernalis plc and Tris Pharma Inc. today announce that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III).
Tuzistra XR is an extended-release oral suspension combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1(H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older. It is indicated for oral use, with or without food, and is to be dosed every 12 hours.
Tuzistra XR is the only codeine based extended-release oral suspension cough-cold treatment in a U.S. prescription cough cold market which sees 30-35 million prescriptions written each year and is estimated to be worth in excess of $3 billion. Currently available short-acting codeine based cough cold treatments account for approximately 38% of that market. Tuzistra XR has been developed using Tris Pharma Inc.’s LiquiXR™ technology.
Ian Garland, Vernalis’ Chief Executive Officer, commented “The approval of Tuzistra XR is a very significant moment in the evolution of Vernalis to a commercial stage speciality pharmaceutical company. We believe this product offers both patients and physicians an extended relief alternative to existing treatments and presents a significant commercial opportunity for Vernalis. We will be working hard over the coming months to launch Tuzistra XR ahead of the 2015-16 U.S. cough-cold season.”
Ketan Mehta, Chief Executive Officer of Tris, commented “This approval demonstrates the continued success of Tris’ OralXR+ technology and is representative of Tris’ history of developing and manufacturing first-to-market liquid sustained-release products that fill significant unmet patient needs. We are excited our collaboration has advanced patient care in a therapeutic category where most adults seek relief in the form of a liquid.”
About Tris Pharma:
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, U.S.A. For more information, please visit https://www.trispharma.com
About Vernalis:
Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has two approved products; Tuzistra™ XR targeting the US prescription cough cold market and, frovatriptan for the acute treatment of migraine. It has an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough cold market as well as eight 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’s 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 Taisho and Tris.
For further information about Vernalis, please visit http://www.vernalis.com.
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company’s current expectations regarding future events including the clinical development and regulatory clearance of the Company’s products, the Company’s ability to find partners for the development and commercialisation of its products, as well as the Company’s future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.