FDA OKs Carbinoxamine ER for Allergic Rhinitis in Children

Megan Brooks

April 03, 2013

The US Food and Drug Administration (FDA) has approved carbinoxamine maleate extended-release (Karbinal ER, Tris Pharma), the first liquid, sustained-release histamine-H1 receptor blocker indicated for the treatment of seasonal and perennial allergic rhinitis in children aged 2 years and older, the company said.

The drug will be available in a 4 mg/5 mL oral suspension.

It is dosed once every 12 hours, "making it an attractive treatment option" for allergy sufferers who do not respond to second-generation antihistamines and are not satisfied with dosing schedules associated with the first-generation antihistamines, Ketan Mehta, founder, president, and chief executive officer of Tris Pharma, said in a statement.

Carbinoxamine is a mildly sedating antihistamine. Before 2006, it was widely used in carbinoxamine-containing combination products. However, most of these older drugs had not gone through the FDA's approval process.

After the Drug Efficacy Study Implementation review, the FDA removed all unapproved products with the exception of 2 immediate-release formulations, "creating a void for patients and doctors who valued the benefits associated with an extended-release formulation," a Tris Pharma news release notes.

"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," Laura Garabedian, MD, a New York State–based pediatrician, said in the news release.

Tris Pharma said Karbinal ER is indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis; vasomotor rhinitis; allergic conjunctivitis resulting from inhalant allergens and foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled; and for the amelioration of the severity of allergic reactions to blood or plasma.