August 19, 2008
Video: ASMANEX(R) TWISTHALER(R) 110 MCG (Mometasone Furoate Inhalation Powder) is Now Available Nationwide for the Maintenance Treatment of Asthma in Children Ages 4 to 11
KENILWORTH, N.J., Aug. 19 /PRNewswire-FirstCall/ -- Schering-Plough Corporation announced today that ASMANEX(R) TWISTHALER(R) 110 mcg (mometasone furoate inhalation powder) is now available in pharmacies nationwide. ASMANEX is indicated for the maintenance treatment of asthma as prophylactic therapy in patients four years of age and older, and is the first and only once-daily inhaled corticosteroid inhaler approved for this use in children as young as 4. ASMANEX was approved for children ages 4 to 11 by the U.S. Food and Drug Administration (FDA) in February 2008. It is not indicated for the relief of sudden asthma symptoms or in children less than 4 years of age.
To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/asmanex/34590/ASMANEX provides physicians with a new treatment option to help manage children's asthma as back-to-school season approaches. Studies show that asthma attacks increase in the back-to-school months, and that asthma emergency room and hospitalization rates spike in September.(1) With asthma affecting more than one child in every 20 in the United States(2), physicians need to help parents and their children be prepared to face the obstacles of managing asthma symptoms during the new school year.
"In my practice, I see an increase in pediatric asthma patients this time of year as children return to school and become exposed to a new environment with new allergens or irritants that may aggravate their symptoms," said Kevin R. Murphy, M.D., board certified pediatric pulmonologist and director of allergy, asthma and pulmonary research at Boys Town National Research Hospital, Omaha, Nebraska. "It is important for parents and their children's physicians to be aware of safe and effective daily treatment options, such as ASMANEX, to treat their child's asthma and prevent symptoms before they start."
When taken every day, maintenance inhalers like ASMANEX can help prevent asthma symptoms, such as coughing, wheezing and shortness of breath.(3) According to updated guidelines from the National Asthma Education and Prevention Program, inhaled corticosteroids are the preferred foundation therapy for initiating long-term control treatment in children with persistent asthma.(4) Daily use of ASMANEX helps manage asthma in patients with persistent asthma, and its automatic dose counter helps patients track remaining doses.
"As the back to school season approaches, it is important for parents to monitor their child's asthma symptoms and work with their physician to determine an appropriate asthma management plan," said Nancy Sander, founder and president of the Allergy & Asthma Network Mothers of Asthmatics. "A once-daily treatment is a useful option to help parents establish a regular routine for their children when taking asthma medication."
Asthma symptoms can occur at any time, so in addition to use of a quick relief inhaler to treat sudden asthma symptoms and managing asthma with a maintenance inhaler, it is also important for parents to work closely with their child's doctor to identify asthma triggers that can exacerbate a child's asthma symptoms during school.(5) For example, classrooms may contain indoor allergens like dust mites and molds, as well as irritants including chalk dust and strong odors.(6) Additionally, children may experience difficulty breathing outside during recess or before and after school, as a result of exposure to outdoor allergens, weather changes and diesel exhaust created by school buses.(6, 7)
About Pediatric Asthma
Asthma is a chronic disorder characterized by inflammation of the air passages, resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.(3, 2) Asthma symptoms, such as coughing, wheezing, and shortness of breath, can occur and can impact multiple aspects of patients' lives.(3) Asthma is the most common chronic condition among children, and it is the cause of almost three million physician visits and 200,000 hospitalizations among children each year in the United States.(2, 8) It is also the third leading cause of hospitalization among children.(2)
ASMANEX 110 mcg has not been demonstrated to be effective in treating asthma symptoms caused by specific asthma triggers.
The U.S. Food and Drug Administration (FDA) approved the use of ASMANEX 110 mcg for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age in February 2008. The approval was based in part on results from a 12-week placebo-controlled trial of 296 patients 4 to 11 years of age who had been diagnosed with mild to moderate persistent asthma for at least six months. Results showed significant improvement in percent predicted FEV1 (forced expiratory volume in one second) from baseline to endpoint in patients treated with ASMANEX 110 mcg once-daily, in the evening, compared to placebo (P=0.002). In this study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of the efficacy of ASMANEX. The only approved dose for children 4 to 11 is 110 mcg (1 puff) administered once daily in the evening.
ASMANEX was discovered and developed by Schering-Plough Research Institute and is currently approved for asthma treatment in more than 40 countries. ASMANEX offers an effective inhaled corticosteroid to help manage asthma symptoms in a device that was awarded the DuPont Award for innovation in packaging. 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.
ASMANEX is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. ASMANEX is not indicated for the relief of sudden asthma symptoms or in children less than 4 years of age. It is available in two dose strengths, 110 mcg for children between 4 and 11 years old, and 220 mcg for patients 12 and older.
ASMANEX is not a rescue inhaler and should not be used to treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma symptoms.
ASMANEX should not be used to treat acute asthma episodes (including status asthmaticus) where extra measures are required.
ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone or any of the ingredients in ASMANEX. There have been cases of hypersensitivity, allergic reactions, facial swelling, hives, and throat tightness reported.
Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX.
It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider as the dosage of ASMANEX should be reduced slowly.
If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.
Avoid coming in contact with measles, chicken pox virus, tuberculosis, or any other infections before or while using ASMANEX. Contact your health care provider immediately if you or your child have been exposed.
Patients who use inhaled steroids, including ASMANEX, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.
Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms.
ASMANEX may increase the risk of some eye problems such as cataracts, glaucoma, and increased intraocular pressure. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
Use ASMANEX as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.
The most common side effects with ASMANEX in patients 4-11 years old include fever, allergic rhinitis, abdominal pain, vomiting, urinary tract infection, and bruise.
The most common side effects with ASMANEX in patients >12 years old include headache, allergic rhinitis, sore throat, and upper respiratory infection.
Full prescribing information is available at: http://www.spfiles.com/piasmanex.pdf
About Schering-Plough Corporation
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to potential market for ASMANEX TWISTHALER 110 mcg. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. 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 Part II, Item 1A. "Risk Factors" in Schering-Plough's 2008 10-Q for the quarterly period ended June 30, 2008, filed August 1, 2008.
1. Johnston, NW et al. The September Epidemic of Asthma Hospitalization: School Children as Disease Vectors. Journal of Allergy and Clinical Immunology. March 2006. Vol. 117(3); 557-562.
2. "Asthma Facts and Figures." Asthma and Allergy Foundation of America, 2005. http://www.aafa.org/display.cfm?id=8&sub=42
3. "What is Asthma?" National Heart Lung and Blood Institute, May 2006. http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html
4. "National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma." National Institutes of Health. National Heart Lung and Blood Institute, 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf
5. "Topic of the Month: August 2005: Preparing for School with Allergies and Asthma." American Academy of Allergy Asthma & Immunology. http://www.aaaai.org/patients/topicofthemonth/0805/
6. "Managing Asthma: A Guide for Schools." National Asthma Education and Prevention Program, July 2003. http://www.nhlbi.nih.gov/health/prof/lung/asthma/asth_sch.pdf
7. Wargo, John. Children's Exposure to Diesel Exhaust on School Buses. Environment & Human Health, Inc. February 2002. http://www.ehhi.org/reports/diesel/dieselintro.pdf
8. "Tips to Remember: Childhood Asthma." American Academy of Allergy Asthma & Immunology, May 2007. http://www.aaaai.org/patients/publicedmat/tips/childhoodasthma.stm
9. Asmanex Twisthaler [package insert]. Kenilworth, NJ: Schering Corporation. 2008.
Press Contact: Julie Lux 908-298-4774 Gail Thornton 908-298-5313 Investor Contact: Janet Barth Joe Romanelli 908-298-7436
CONTACT: Press, Julie Lux, +1-908-298-4774, or Gail Thornton,+1-908-298-5313; or Investors, Janet Barth or Joe Romanelli, +1-908-298-7436,all for Schering-Plough Corporation
Web site: http://www.spfiles.com/piasmanex.pdfhttp://www.schering-plough.com/