According to an FDA spokesperson, the FDA Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted not to support approval of Armstrong Pharmaceuticals’ NDA for Primatene HFA during a joint meeting on February 25, 2014.
Armstrong is seeking to market the epinephrine MDI over the counter for the treatment of asthma. The company marketed a CFC formulation of the product, called Primatene Mist, until it was phased out in accordance with the Montreal Protocol in December 2011. The proposed dose for the HFA inhaler is 125 mcg compared to 200 mcg for Primatene Mist.
The committee members voted 14 to 10 in agreement that “the efficacy data provide substantial evidence for the OTC use of epinephrine inhalation aerosol 125 mcg per inhalation in adults and children 12 years of age and older for the proposed indication, ‘the temporary relief of mild symptoms of intermittent asthma, including wheezing, tightness of chest, and shortness of breath.’” However, on the question of safety, the vote was 17 to 7 against.
Only 6 committee members agreed that “the risk/benefit profile of epinephrine inhalation aerosol 125 mcg per inhalation supportive of OTC use for the temporary relief of mild symptoms of intermittent asthma,” with 18 voting no.
A transcript of the meeting will be posted on the FDA web site at some time in the future.
