Magazine article Drug Topics

OTC Asthma Inhalers: Worthy of More Time on Market?

Magazine article Drug Topics

OTC Asthma Inhalers: Worthy of More Time on Market?

Article excerpt

The manufacturer of over-the-counter epinephrine pressurized metered-dose inhalers (MDIs) is asking the Food & Drug Administration to give it an extra year -from the end of 2010 to the end of 2011-to get the chlorofluorocarbons (CFCs) out of its product. Armstrong Pharmaceuticals claims that without the extra time, it will likely have to take the product off the market.

The Allergy and Asdima Network Mothers of Asthmatics (AANMA) is asking the agency not to grant the extension, saying that asthma sufferers who use the overthe-counter product should transition to prescription products. According to FDA, epinephrine MDIs are the only MDIs for treatment of asthma, or any other disease, approved for OTC use.

The organization's comments came in an hour-long hearing at FDA offices in Rockville, Md., last month. The meeting focused on the agency's proposed rule, published in the Federal Register September 20, to prohibit CFC use in the product after 2010.

That action is part of the final phase-out of CFCs worldwide following research that found that the substances cause dunning of the ozone layer. In a separate proposed rule, published on June 11, 2007, the agency is also considering ending permission for CFC use in seven prescription inhalants by the end of 2009.

Robert M. Sussman, counsel representing Armstrong Pharmaceuticals at the recent FDA hearing, said that the extra year will provide sufficient time for development and approval of an OTC nonozone-depleting based epinephrine "and eliminate a one-year gap in which there is no OTC epinephrine formulation on the market."

"We recognize that epinephrine MDI is not the drug of choice for physicians treating asthma patients. Nonetheless this product serves a vital role in serving this patient population and is relied upon by as many as 1.7 to 2.3 million people with asthma," Sussman said.

He pointed out that "FDA has estimated that between 9% and 14% of OTC epinephrine users face barriers to health care," indicating that it may be difficult for those people to see a physician or obtain prescription medications. …

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