FDA accepts Tris' Extended Release Carbinoxamine Oral Suspension NDA for allergies in kids

Tris PharmaMar 10 2011

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced today that the US Food and Drug Administration (FDA) has accepted its Extended Release Carbinoxamine Oral Suspension NDA for the treatment of allergies in kids two years and older.  If approved, Tris Pharma's Extended Release Suspension will provide an alternative to the currently available immediate release formulations.

Carbinoxamine is a mildly sedating antihistamine with years of proven safety and efficacy.  Prior to 2006 carbinoxamine was widely used, with more than 100 marketed Carbinoxamine containing products including extended release solid dose and combination products.  However, nearly all of these were older products which hadn't gone through the FDA's rigorous approval process.  Following the 2006 DESI review, the FDA removed all carbinoxamine based products with the exception of two immediate release formulations which had been reviewed, creating a void for patients and doctors who valued the benefits associated with an extended release formulation.

A leading New York based pediatrician, Dr. Laura Garabedian, who often prescribes Carbinoxamine said, "I've always found Carbinoxamine extremely effective in treating allergy symptoms in children but don't typically prescribe it as first line therapy because the existing immediate release formulations need to be dosed multiple times per day including a dose while the child is in school thus making compliance poor.   I am looking forward to a true 12 hour formulation that tastes good.   The new product profile should translate to improved compliance and better outcomes."

Ketan Mehta, Tris President and CEO added, "This is the fourth NDA submission based on Tris' OralXR+ technology platform including Nexiclon™ XR,  a recently launched first ever 24-hour liquid Extended Release Suspension. Tris' pipeline includes several additional products targeted for the respiratory market, i.e. cough, cold, allergy therapies and are slated for submission over the next two years. Tris plans to launch Carbinoxamine Extended Release Suspension in 2012 season and is currently evaluating its options including partnering with other specialty Pharma companies. "