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FDA Approves Tris Pharma's New Drug Application for Karbinal ER Extended-release Oral Suspension

Wed, 04/03/2013 - 7:51am

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the FDA has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

"Karbinal ER is dosed only once every 12 hours, making it an attractive treatment option for the millions of allergy sufferers who don't respond to second-generation antihistamines and aren't satisfied with the cumbersome dosing schedules associated with the first-generation antihistamines," said Ketan Mehta, founder, President, and CEO of Tris Pharma. "The approval of Karbinal ER marks our fourth liquid extended-release NDA approval based upon our proprietary OralXR+ technology. We are in the process of finalizing our marketing partner and plan to launch later this year in anticipation of the fall allergy season." Based on physician interviews approximately 30 percent of patients don't get adequate relief from the non-sedating antihistamines.

Carbinoxamine is a mildly-sedating antihistamine with years of proven safety and efficacy. Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing combination products including extended-release solid-dose products. However, nearly all of these were older products that hadn't gone through the FDA's rigorous approval process. Following the Drug Efficacy Study Implementation (DESI) review, the FDA removed all unapproved products with the exception of two immediate-release formulations, creating a void for patients and doctors who valued the benefits associated with an extended-release formulation.

Dr. Laura Garabedian, a New York-based pediatrician, said, "While I've always found carbinoxamine to be an effective option for treating the symptoms of allergies in children, the existing immediate-release formulations of carbinoxamine require dosing multiple times a day.

This is especially inconvenient for children who are in school. Now, with the approval of Karbinal ER, I look forward to having an effective and great-tasting extended-release liquid formulation to offer patients as young as two years old."  

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