ASTEPRO(TM) (azelastine hydrochloride) Nasal Spray Hits U.S. Pharmacies
SOMERSET, N.J., Jan. 15 /PRNewswire/ -- This allergy season, a new medication is available to manage the symptoms of seasonal allergic rhinitis, a condition that impacts as many as 40 million people in the United States. ASTEPRO Nasal Spray contains azelastine in a unique vehicle formulated for enhanced patient benefits. Azelastine is the active ingredient in ASTELIN(R) (azelastine hydrochloride), a leading antihistamine nasal spray. Prescription ASTEPRO(TM) Nasal Spray 137 mcg offers powerful efficacy, rapid relief and improved tolerability. ASTEPRO Nasal Spray is approved by the United States Food and Drug Administration (FDA) for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
Seasonal allergic rhinitis can significantly impact quality of life and patients may experience persistent allergy symptoms for many years. ASTEPRO Nasal Spray has demonstrated powerful efficacy in treating the full range of these symptoms, including nasal congestion. It is steroid-free and contains no pseudoephedrine - ingredients sometimes of concern to patients. ASTEPRO Nasal Spray provides rapid symptom relief patients want -- in as early as 30 minutes.
"When pollen counts are at their highest and nasal allergy symptoms erupt, patients simply want effective and fast-acting relief of nasal symptoms including congestion with a well tolerated medication," said Chuck Siegel, M.D., Associate Clinical Professor,
Seasonal allergic rhinitis can cause symptoms that can last for an extended period of time including stuffy or runny nose, sneezing, itchy nose, itchy eyes or watery eyes, and coughing caused by clear mucus running down the back of throat. Pollen seasons are predictable, with more people typically suffering from allergy symptoms in the spring when trees are flowering and shedding their pollen.
"We are very excited about the introduction of ASTEPRO Nasal Spray here in the United States," said Sharon Clarke, President, MEDA Pharmaceuticals Inc. "We have worked hard to ensure the widest physician and patient access to this important new medication during the upcoming allergy season. Furthermore, we are offering a discount Go Pro Card for instant savings on eligible patients' first ASTEPRO Nasal Spray prescription fulfillment," said Clarke. "ASTEPRO Nasal Spray represents the first North American allergy product launch for MEDA, so it is truly a milestone for the company as well."
ASTEPRO Nasal Spray is an antihistamine nasal spray formulated as a metered-dose solution for intranasal administration. ASTEPRO Nasal Spray is formulated with sucralose, a non-caloric sweetener with proven safety in more than 100 scientific studies. In a double-blind, placebo-controlled clinical study of the original formulation of azelastine nasal spray (ASTELIN(R)), new ASTEPRO and placebo, patients using ASTEPRO Nasal Spray reported significant symptom relief and a lower incidence of bitter taste and nasal discomfort than with the original formulation. This data will be presented at the 47th Annual Meeting of the Western Society of Allergy, Asthma and Immunology January 25-30, 2009 in Maui, Hawaii. Dosages of ASTEPRO for adults and people 12 years of age and older are 1 or 2 sprays per nostril twice daily.
The key ingredient in ASTEPRO Nasal Spray, azelastine, has proven to deliver powerful efficacy in multiple double-blind clinical studies which included oral antihistamines such as Zyrtec(R), Allegra(R), and Claritin(R).
ASTEPRO (azelastine hydrochloride) Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
The most commonly reported adverse events seen with ASTEPRO Nasal Spray were dose related (1 and 2 sprays per nostril respectively) and included bitter taste (6%-7%), epistaxis (2%-3%), headache (1%-3%), nasal discomfort (0%-1%), fatigue (0%-2%), and somnolence (1%-2%).
Avoid engaging in hazardous occupations requiring complete mental alertness when taking ASTEPRO Nasal Spray.
Avoid concurrent use of alcohol or other central nervous system depressants with ASTEPRO Nasal Spray.
ASTEPRO Nasal Spray is available by prescription only.
Onset of Action
In a 2 week SAR study in 284 patients, ASTEPRO administered 2 sprays per nostril twice daily demonstrated an onset of action vs. placebo vehicle at 30 minutes and sustained efficacy vs. placebo through the end of the 2 week study period.
In a second 2 week SAR study in 343 patients, ASTEPRO administered 2 sprays per nostril twice demonstrated an onset of action vs. placebo vehicle at 240 minutes and sustained efficacy vs. placebo through the end of the 2 week study period.
Please see full prescribing information available at www.astepro.com or contact MEDA Medical Affairs Department at 800-526-3840.
About MEDA Pharmaceuticals Inc. and MEDA, AB
MEDA Pharmaceuticals Inc. is the U.S. subsidiary of MEDA AB. MEDA Pharmaceuticals specializes in respiratory, allergy, central nervous system, and cough-cold products. MEDA AB is an international specialty pharma company that concentrates on marketing and market-adapted product development. Acquisitions and long-term partnerships are fundamental factors that drive the company's strategy. MEDA is represented with own organizations in 26 countries and with more than 1,500 employees within marketing and sales. MEDA's products are sold in approximately 120 countries world-wide. The MEDA share is listed under Large Cap on the OMX Nordic Stock Exchange. Find out more about MEDA AB by visiting www.meda.se.
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