The one-time $100 million asthma-relief brand Primatene may make a comeback to the marketplace after a more than two-year hiatus. Primatene Mist had been withdrawn from the market in December 2011 when the agency removed all inhalers containing chlorofluorocarbons from the market.
The Nonprescription Drugs Advisory Committee will be meeting Feb. 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 mcg/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers ages 12 years and older.
The demand for an asthma inhaler in the self-care space is there. Nephron Pharmaceuticals has been seeing quite a lift in sales of its Asthmanefrin nasal spray, which reached $17.7 million, up 987%, for the 52 weeks ended Dec. 1 across total U.S. multi-outlets, according to IRI. Asthmanefrin contains racepinephrine USP 11.25 mg, a bronchodilator.
There also are homeopathic solutions that have carved out a niche in the asthma space. At the 2013 NACDS Total Store Expo, Homeolab launched its Real Relief Asthma Nighttime product. Retailing for a suggested $11.99, the homeopathic tablets help relieve symptoms associated with asthma, including gasping for air, difficulty breathing, wheezing, coughing and excess mucus. And homeopathic supplier King Bio in 2012 launched its AsthmaCare homeopathic spray.
According to the Asthma and Allergy Foundation of America, 25 million Americans have asthma.