FDA approves cough, cold drug

May 4, 2015

FDA has approved codeine polistirex and chlorpheniramine polistirex (Tuzistra XR, Vernalis plc and Tris Pharma) extended-release oral suspension, CIII (DEA Schedule III).

FDA has approved codeine polistirex and chlorpheniramine polistirex (Tuzistra XR, Vernalis plc and Tris Pharma) extended-release oral suspension, CIII (DEA Schedule III).

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Tuzistra XR is the only codeine-based extended-release oral suspension cough-cold treatment that is dosed every 12 hours, in a US prescription cough cold market which sees 30 to 35 million prescriptions written each year. Short-acting codeine based treatment options account for approximately 38% of this market.

Tuzistra XR was developed using a liquid sustained-release technology, LiquiXR which enables 12 hour dosing.

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Parker

“Until now, physicians looking for an extended-release prescription antitussive that is dosed every 12 hours have been limited to DEA Schedule II products such as hydrocodone combination products,” said Thomas Parker, senior vice president commercial operations, Vernalis. “Tuzistra XR is the only option that gives physicians the same extended-release dosing, but is a Schedule III product.”

Tuzistra XR will be priced competitively with other branded prescription antitussives, according to Parker. Pricing information will be available upon product availability.

Cough is the most common complaint seen by primary care physicians. It accompanies the common cold up to 83% of the time and was reported as a symptom in 47% of patients diagnosed with allergic rhinitis.

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