Vernalis Therapeutics Inc., a subsidiary of Vernalis plc (LSE: VER), today announced that Tuzistra™ XR (codeine polistirex and chlorpheniramine polistirex), extended-release oral suspension, CIII (DEA Schedule III) is now available to adult patients and physicians in the United States.
Tuzistra XR, the only codeine-based cough and cold syrup dosed every 12 hours, was approved by the U.S. Food and Drug Administration on April 30, 2015. It is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Tuzistra XR was developed using a liquid sustained release technology, LiquiXR™, which enables a 12-hour dosing period.
"The launch of Tuzistra XR marks a significant milestone for Vernalis Therapeutics and demonstrates our capability to build a broad portfolio of unique, long-acting, liquid formulations of branded prescription cough cold products in the U.S. market," said Tom Parker, Senior Vice President of Commercial Operations, Vernalis Therapeutics, Inc. "We are pleased to offer physicians and patients a proprietary Schedule III, 12-hour, codeine and chlorpheniramine combination liquid product to help manage cough and cold symptoms in advance of this year's cough cold season."
"Until now, physicians looking to prescribe a codeine-containing antitussive have been limited to short-acting medications," said Pascal Borderies, MD, SVP Medical Affairs, Vernalis Therapeutics, Inc. "Tuzistra XR's extended-release liquid delivery system allows for less frequent dosing than traditional codeine cough syrups. This makes it a viable option for patients looking to extend the relief of cough and symptoms associated with upper respiratory allergies or the common cold with twice-daily dosing."
SOURCE Vernalis Therapeutics, Inc.