FDA advisory committees turn down Primatene HFA application for OTC status

SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

Panelists at the joint meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee voted 18 against and six in favor of bringing what amounts to Primatene Mist — a one-time $100 million brand — back to store shelves. 

A small majority (14-10) advised that the Primatene HFA inhaler was efficacious, but safety was an issue. The two panels voted 17-7 against its safety for OTC use. 

The most common adverse events that occurred more frequently in more than 3% of patients were tremor, throat irritation, cough, chest discomfort and feeling jittery, according to a published report. 

“OTC … provides asthmatics access without the need for additional visits to a physician’s office or to a hospital emergency room," testified David Spangler, SVP policy and general counsel & secretary for the Consumer Healthcare Products Association. "This availability especially benefits those asthmatics whose attacks are triggered by common environmental factors when immediate use may be essential. In addition, physician-diagnosed asthmatics who do not have easy access to medical care will continue to benefit from OTC use.”