Vernalis and Tris Pharma announced that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension.
Tuzistra XR is a Schedule III controlled substance indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged ≥18 years. Tuzistra XR combines codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H1) receptor antagonist. The product utilizes Tris Pharma’s LiquiXR technology.
In March 2013, proof-of-concept was demonstrated; by February 2014, single-dose and multi-dose bioavailability studies were completed.
It is the first codeine-based extended-release oral suspension cough and cold treatment on the market. Tuzistra XR will be available as a cherry-flavored liquid oral suspension in a 14.7mg/2.8mg per 5mL strength in 473mL bottles. It is expected to launch for the 2015-16 cold season.
For more information call (855) 705-9546 or visit Vernalis.com.