New Cough Combatant Nabs FDA Approval

The FDA today approved a new cough and cold treatment that is also intended for adults with symptoms related to upper respiratory allergies.

The FDA today approved a new cough and cold treatment that is also intended for adults with symptoms related to upper respiratory allergies.

The approval is for Vernalis and Tris Pharma’s extended-release oral suspension formulation of codeine polistirex and chlorpheniramine polistirex (Tuzistra XR).

“We are excited our collaboration has advanced patient care in a therapeutic category where most adults seek relief in the form of a liquid,” Tris CEO Ketan Mehta said in a press release.

The treatment combines an opiate agonist antitussive with a histamine-1 receptor antagonist to provide relief for patients aged 18 years and older.

Patients will be able to take Tuzistra XR with or without food, and it should be dosed every 12 hours.

“We will be working hard over the coming months to launch Tuzistra XR ahead of the 2015-16 US cough-cold season,” Vernalis CEO Ian Garland said in a press release.

According to Vernalis, Tuzistra XR is the only codeine-based extended-release oral suspension cough-cold treatment in the US prescription cough-cold market.