Graceway Pharmaceuticals, LLC today announced that the Food and Drug Administration (“FDA”) published a long-awaited Final Rule regarding the continued availability of Maxair Autohaler (pirbuterol acetate inhalation aerosol) and other pressurized metered-dose inhalers containing chlorofluorocarbons (CFCs). Under the rule, Maxair Autohaler will remain available for physicians and patients through December 31, 2013.
In support of its decision, FDA noted that it received a large number of comments from physicians and patients addressing the public health benefits of pirbuterol – the active ingredient in Maxair Autohaler. FDA likewise observed that the need for patient education was an important factor in extending the effective date of the rule, and the Agency committed to actively monitor the patient transition to CFC-free alternatives.
Graceway’s Chairman and CEO, Jefferson J. Gregory, stated, “We are extremely pleased that the FDA has allowed Maxair to remain on the market while we continue our development efforts for a CFC-free formulation. This means that patients who rely on Maxair can continue to use it for the unique benefits it provides in asthma rescue therapy.”
Details of FDA’s final rule can be found in the April 14, 2010 issue of the Federal Register, and FDA has also posted more information on its website, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208302.htm
The Only MDI with Pirbuterol
Maxair Autohaler is the only MDI that uses pirbuterol as its active ingredient. As a pharmacologically distinct medication, pirbuterol provides an alternative to albuterol for patients needing asthma rescue therapy.
About Maxair Autohaler
Maxair Autohaler is indicated for prevention and reversal of bronchospasm in patients aged 12 years and older with reversible bronchospasm including asthma. It may be used with or without concurrent theophylline and/or corticosteroid therapy.
IMPORTANT SAFETY INFORMATION
Maxair Autohaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients. Maxair Autohaler, like other inhaled beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or other symptoms. Although such effects are uncommon after administration of Maxair Autohaler at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown.
Therefore, Maxair Autohaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Maxair Autohaler can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, Maxair Autohaler should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, eg, corticosteroids. The following adverse reactions were reported more frequently than 1 in 100 patients: nervousness (6.9%), tremor (6.0%), headache (2.0%), dizziness (1.2%), palpitations (1.7%), tachycardia (1.2%), cough (1.2%), and nausea (1.7%).
About Graceway Pharmaceuticals®, LLC
Graceway Pharmaceuticals®, LLC (“Graceway”), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Graceway initially acquired Maxair Autohaler as part of its acquisition of 3M’s (NYSE: MMM) branded pharmaceutical business in the United States, Puerto Rico, Canada and Latin America. Graceway has also recently completed acquisitions of other molecules or compounds from, among other companies, Pfizer, Inc. (NYSE: PFE) and Gilead Sciences, Inc. (NASDAQ: GILD). Current prescription products marketed by Graceway include Aldara® (imiquimod) Cream, 5%; Maxair®Autohaler® (pirbuterol acetate inhalation aerosol); Atopiclair® Nonsteroidal Cream; and Estrasorb® (estradiol topical emulsion). Aldara®, Maxair®, Autohaler®, Atopiclair®, and Estrasorb® are trademarks owned by or licensed to Graceway. For more information on Graceway’s products, including important safety information, please visit www.gracewaypharma.com.
Graceway Pharmaceuticals, LLC
John A. A. Bellamy
Executive Vice President & General Counsel