FDA
26th February 2014

FDA AdComm Does Not Endorse Primatene HFA Inhaler for Asthma

The panels voted in favor of the drug’s efficacy (14 yes, 10 no, 1 no vote) and against its safety (7 yes, 17 no, 1 no vote) for OTC use. Several committee members voiced concern that if the inhaler is available OTC, people may be inclined to use it in lieu of seeking appropriate medical treatment.

FDA AdComm Does Not Endorse Primatene HFA Inhaler for Asthma

Yesterday, the Nonprescription Drugs Advisory Committee and the Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted against (18 no, 6 yes, 1 no vote) recommending over-the-counter (OTC) marketing of epinephrine inhalation aerosol 125 microgram (mcg)/actuation (E004; proposed trade name, Primatene HFA, Armstrong Pharmaceuticals, Inc), for temporary relief of mild symptoms of intermittent asthma for people aged 12 years or older.

The panels voted in favor of the drug’s efficacy (14 yes, 10 no, 1 no vote) and against its safety (7 yes, 17 no, 1 no vote) for OTC use. Several committee members voiced concern that if the inhaler is available OTC, people may be inclined to use it in lieu of seeking appropriate medical treatment. The HFA inhaler also requires special care to prevent inaccurate dosing, and some members were concerned that patients might not use and care for the inhalers properly.

Epinephrine-HFA is a short-acting beta2-agonist (SABA) bronchodilator used to provide quick relief for acute bronchospasm. If approved, E004 would be the only OTC metered-dose inhaler bronchodilator on the US market. Currently available prescription SABAs include albuterol and levalbuterol.

E004 is intended to replace the OTC inhaler epinephrine metered inhaler 200 mcg/actuation (Primatene Mist, Armstrong Pharmaceuticals, Inc), which was phased out in December 2008 because it used chlorofluorocarbons as the propellant. Chlorofluorocarbons were banned because they deplete the earth’s ozone layer, and the new formulation uses hydrofluoroalkane (HFA), which is more environmentally friendly.

Additionally, there are some other nuisances associated with this newer HFA formulation. For example, it is a suspension, which is sticky and prone to settling. The HFA inhalers must be shaken well before each use to ensure accurate dosing. The HFA inhaler must be primed 4 times before the first use and twice after 2 weeks of non-use. The device must be disassembled, washed thoroughly, and dried each day to prevent clogging.

“I’m worried about the device, in terms of the implications if it’s not handled correctly — we don’t really have any data on that,” said voting Nonprescription Drugs Advisory Committee member Ralph B. D’Agostino Sr, PhD, professor of mathematics and statistics, biostatistics, and epidemiology, and director, statistics and consulting unit, at Boston University, Massachusetts.

Michael K. Paasche-Orlow, MD, MA, MPH, an associate professor of medicine at Boston University School of Medicine in Massachusetts added that the label instructions to rinse the inhaler daily after use might lead patients to believe that it is for daily use, when it is intended for intermittent use.

Dr. Paasche-Orlow explained, “Many of the patients that come to tell me that they have asthma don’t have asthma and would be using this product, and probably would be using it every day.”

On the other hand, voting Pulmonary-Allergy Drugs Advisory Committee member Kathryn Blake, PharmD, principal research scientist, Nemours Children’s Clinic, in Jacksonville, Florida noted that this product may be useful in certain circumstances. She explained that, “One of the reasons I voted yes is for that single patient who needs to use it on a single occasion because they’re out of town, because that’s the closest place that they can get relief because they’ve run out of their inhaler or whatever else.”

The FDA is not bound by their panels’ recommendation; however, they often abide by it.

Please click HERE to access the original meeting announcement for this product.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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