Asthma - FDA Approves ASMANEX(R) (mometasone furoate) for Once Daily Management

Main Category: Respiratory / Asthma
Article Date: 02 Apr 2005 - 3:00 PDT

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Studies Show Improved Lung Function, Decreased Use of Rescue Medication and Significant Improvement in Day and Nighttime Symptoms -

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of ASMANEX(R) TWISTHALER(R) 220 mcg (mometasone furoate inhalation powder) for the first-line maintenance treatment of asthma as preventive therapy in patients 12 years of age and older. ASMANEX is also the only inhaled asthma controller therapy approved for once daily initiation and management of asthma in patients previously treated with bronchodilators alone or inhaled corticosteroids. Clinical studies with ASMANEX have shown substantial improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings and significant improvements in daytime symptoms such as coughing and wheezing.

"ASMANEX is a highly effective first-line therapy that offers health care professionals and their patients a once daily therapy to help prevent persistent asthma symptoms," said Harold Nelson MD, Professor of Medicine, Department of Medicine, National Jewish Medical and Research Center, University of Colorado Health Science Center in Denver, Colo.

In a clinical trial, ASMANEX showed substantial improvement in lung function and decreased albuterol (rescue medication) use compared with placebo, as evidenced by a 12-week, multicenter, randomized, double-blind, placebo-controlled study of 400 patients with persistent asthma previously dependent on inhaled corticosteroid therapy. At endpoint, patients who received ASMANEX had a significant improvement in nighttime awakenings and daytime symptoms -- providing night and day relief.(1)

The NAEPP (National Asthma Education and Prevention Program) asthma treatment guidelines recommend single-ingredient, low-dose inhaled corticosteroid as the foundation of therapy for mild persistent asthma management.

Asthma is a chronic inflammatory lung disease that affects a growing number of Americans each year. The number of cases has grown steadily in the past 20 years, making it one of the leading public health problems in the U.S.(2) As many as 20 million people suffer from asthma.(3) On an annual basis, this leads to at least two million emergency room visits and more than 5,000 deaths.(4) Additionally, this accounts for an annual direct cost of treatment of $9.4 billion(5) and approximately 14.5 million missed work days.(6) Asthma symptoms such as coughing, wheezing, and shortness of breath(7) occur during the day and night, impacting multiple aspects of patients' lives. Daytime symptoms can affect activities ranging from exercise to going to school or work.(8) Nighttime symptoms interfere with patients' ability to sleep.(9)

ASMANEX was discovered and developed by Schering-Plough Research Institute and is currently approved for asthma treatment in more than 40 countries. Mometasone furoate, the active ingredient in ASMANEX, was first introduced in the U.S. in 1987 as the dermatologic ointment, ELOCON (mometasone furoate ointment) and in 1997 as the nasal spray, NASONEX (mometasone furoate monohydrate).

In clinical trials with ASMANEX, adverse events were generally mild to moderate in severity. The following incidence of common adverse experiences is based on double-blind data from ten placebo-controlled clinical trials involving a total of 2,809 patients previously maintained on inhaled steroids and/or bronchodilators (1,140 males, 1,669 females, age 12-83 years), who were treated for up to 12 weeks with the ASMANEX product, an active comparator, or placebo. Adverse events were generally mild to moderate in severity and included headache, allergic rhinitis, pharyngitis, upper respiratory infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, dyspepsia, myalgia, abdominal pain, and nausea.(10)

ASMANEX offers an effective inhaled corticosteroid to control asthma symptoms in an easy to use device that was awarded the DuPont Award for innovation in packaging.(11) The ASMANEX TWISTHALER employs an inhalation- driven device that does not use a propellant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.

Recommended starting dose of ASMANEX is one inhalation daily in the evening for patients previously treated with bronchodilators alone or inhaled corticosteroids. For patients previously maintained on oral corticosteroids, the recommended starting dose of ASMANEX is two inhalations twice daily.

Full prescribing information is available at:
spfiles.com/piasmanex.pdf
ASMANEX is expected to be available in the U.S. in the autumn of 2005.

ABOUT SCHERING-PLOUGH:

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE:

The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including the expected availability of ASMANEX in the U.S. and the market for drugs to treat asthma. Forward- looking statements relate to expectations or forecasts of future events and use words such as "expected," "will," and "may." Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering- Plough's forward-looking statements. These factors include market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, the regulatory process for new products and new indications, timing of trade buying, and matters impacting patents on Schering-Plough products. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's 2004 annual report on Form 10-K.

1 A D'Urzo, et al. J Allergy Clin Immunol 2003; 111(2):S218 [Abstract 597], "Effects of Once-Daily Evening Dosing with Mometasone Furoate Dry Powder Inhaler on Symptom Control in Mild to Moderate Asthma."

2 Global Initiative for Asthma: Pocket Guide for Asthma Management in Children, 2003.

3 "Asthma Prevalence, Health Care Use and Mortality, 2000-2001," National Center for Health Statistics, Centers for Disease Control and Prevention.

4 American Lung Association. Epidemiology and Statistics Unit, Research and Scientific Affairs. Trends in Morbidity and Mortality, April 2004.

5 Ibid.

6 The State of Health Care Quality: 2004: National Committee for Quality Assurance (NCQA)

7 "Asthma Prevalence, Health Care Use and Mortality, 2000-2001," National Center for Health Statistics, Centers for Disease Control and Prevention.

8 "Asthma," an eMedicine manuscript by Michael J. Morris, MD, Assistant Chief, Clinical Investigation, Dept. of Medicine, Brooke Army Medical Hospital, updated February 9, 2005, www.emedicine.com (accessed Tuesday, March 8, 2005).

9 "Epidemiology of Nocturnal Asthma," Margaret Turner Warwick, DM, Ph.D., FRCP, The American Journal of Medicine, July 29, 2988 p. 8.

10 ASMANEX Product Insert.

11 Gold winner, non-food category, 12th Annual DuPont Awards for Innovation in Food Processing and Packaging Technology, an international industry competition to recognize food and non-food industry advances that use plastic materials, 1999. Competition sponsored by DuPont in cooperation with Campden and Chorleywood Food Research Association in Gloucestershire, England, and the National Food Processors Association in Washington, D.C.

CONTACT: Media - Mary-Frances Faraji, +1-908-298-7109, or Cell, +1-908-432-2404, or Investors - Alex Kelly or Janet M. Barth, +1-908-298-7436

http://www.schering-plough.com