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news.Vernalis and Tris Pharma have received approval from the US Food and Drug Administration (FDA) for its new drug application (NDA) of Tuzistra extended-release oral suspension, CIII (DEA Schedule III) for relief of cough in adults aged 18 years and older.
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Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine indicated for oral use for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults.
Codeine is an opiate agonist antitussive, while chlorpheniramine is a histamine-1(H1) receptor antagonist.
Vernalis chief executive officer Ian Garland said: "The approval of Tuzistra XR is a very significant moment in the evolution of Vernalis to a commercial stage speciality pharmaceutical company.
"We believe this product offers both patients and physicians an extended relief alternative to existing treatments and presents a significant commercial opportunity for Vernalis.
"We will be working hard over the coming months to launch Tuzistra XR ahead of the 2015-16 US cough-cold season."
The company said that Tuzistra XR is the only codeine based extended-release oral suspension cough-cold treatment in a US prescription cough cold market.
Tris CEO Ketan Mehta said: "This approval demonstrates the continued success of Tris’ OralXR+ technology and is representative of Tris’ history of developing and manufacturing first-to-market liquid sustained-release products that fill significant unmet patient needs."