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.

For more details, go to: http://www.vernalis.com/media-centre/latest-releases/703-vernalis-and-tris-pharma-receive-fda-approval-of-nda-for-tuzistra-xr-codeine-polistirex-and-chlorpheniramine-polistirex