First Codeine-Based Ext-Rel Cough Suspension Approved

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.

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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.

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