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FDA Approves Tuzistra XR (Codeine/ Chlorpheniramine) for Relief of Cough in Adults

First codeine-based, extended-release, oral-suspension cough/cold treatment in U.S.

The FDA has approved Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III), for the relief of cough and of symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. It is not indicated for pediatric patients under 18 years of age.

Tuzistra XR is an extended-release oral suspension combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1(H1) receptor antagonist. It is approved for oral use, with or without food, and is to be dosed every 12 hours.

According to its developers (Vernalis LLC and Tris Pharma Inc.), Tuzistra XR is the only codeine-based, extended-release, oral-suspension cough/cold treatment in a U.S. prescription cough/cold market that sees 30 to 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 was developed using Tris Pharma's LiquiXR technology.

Tuzistra XR is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a cytochrome P450-2D6 polymorphism.

Tuzistra XR is also contraindicated in patients with known hypersensitivity to codeine, chlorpheniramine, or any of the inactive ingredients of Tuzistra XR. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine.

Source: Vernalis; May 1, 2015.

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