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.”