FDA approves only once-daily inhaled corticosteroid for children

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved ASMANEX TWISTHALER 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age.

ASMANEX is an inhaled corticosteroid (ICS). ASMANEX 220 mcg was approved on March 31, 2005 by the FDA for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.

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.1,2 Taken every day, maintenance inhalers help prevent asthma symptoms.

“As the first inhaled corticosteroid that is approved for once-daily dosing in children as young as age four, the approval of the pediatric indication for ASMANEX provides an important treatment option for children with moderate and mild persistent asthma,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute.

According to updated guidelines from the National Asthma Education and Prevention Program, inhaled corticosteroids are the preferred foundation therapy for initiating long-term control in children with persistent asthma.3

Continual use of ASMANEX helps manage asthma symptoms in patients with persistent asthma. Additionally, its automatic dose counter helps patients track remaining doses.

The FDA approval of ASMANEX for pediatric use is 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 asthma for at least six months. Results showed significant improvement in percent predicted FEV1 (forced expiratory volume in one second) in patients treated with ASMANEX 110 mcg once-daily, in the evening, compared to placebo. In this study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of the efficacy of ASMANEX TWISTHALER.4 The only recommended dose for children 4-11 is 110 mcg (1 puff) administered once daily in the evening.

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.1,5 Asthma symptoms, such as coughing, wheezing, and shortness of breath, occur during the day and night, impacting multiple aspects of patients’ lives.5 Daytime symptoms can affect activities such as exercising or going to school.6 Nighttime symptoms interfere with patients' ability to sleep.7 Asthma affects more than one in every 20 children, and it is the third leading cause of hospitalization among children under the age of 15.1,8 It is also the most common cause of school absenteeism due to chronic disease, and it accounts for an annual loss of more than 14 million school days per year.1 The estimated cost of treating asthma in those younger than 18 years of age is $3.2 billion per year.9

About ASMANEX4

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 acute bronchospasm or in children less than 4 years of age.

ASMANEX TWISTHALER therapy should not be used to treat sudden asthma attacks. A fast acting inhaler is still needed to relieve sudden asthma symptoms.

Patients should be careful while adjusting to a switch from an oral steroid to the inhaled steroid ASMANEX. Patients should be followed closely by their doctor. Death can occur. Patients should tell their doctor 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 a patient is under stress, such as with surgery, after surgery or trauma, they may need steroids by mouth again.

Inhaled steroids including ASMANEX TWISTHALER may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route.

Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth. Patients should rinse their mouth after using ASMANEX.

Patients should contact their health care provider if they have or had tuberculosis, are exposed to chickenpox or measles, or about any other infections they had before or while using ASMANEX.

If a patient is at an increased risk for decreased bone mineral density, the use of corticosteroids may increase their risk. The health care provider should monitor their condition and, if needed, provide treatment.

Long-term use of inhaled corticosteroids, such as ASMANEX, may increase the risk of some eye problems such as cataracts or glaucoma.

Use ASMANEX as directed by your health care provider, since its ability to work in your lungs depends on regular use. If a patient’s asthma symptoms do not improve, or get worse, they should contact their health care provider.

The most common side effects with ASMANEX TWISTHALER include headache, nasal allergy symptoms, sore throat, upper respiratory infection, sinus infection, fungal infections of the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.

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. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company’s ongoing transformation. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world.

References:

1. “Asthma Facts and Figures.” Allergy and Asthma Foundation of America, 2005. http://www.aafa.org/display.cfm?id=8&sub=42

2. “Tips to Remember: Childhood Asthma.” American Academy of Allergy Asthma & Immunology, May 2007. http://www.aaaai.org/patients/publicedmat/tips/childhoodasthma.stm

3. “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

4. Asmanex Twisthaler [package insert]. Kenilworth, NJ: Schering Corporation. 2008.

5. “What is Asthma?” National Heart Lung and Blood Institute, May 2006. http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html

6. “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).

7. “Epidemiology of Nocturnal Asthma,” Margaret Turner Warwick, DM, Ph.D., FRCP. The American Journal of Medicine, July 29, 1988.

8. “Asthma & Children Fact Sheet.” American Lung Association, December 2007. http://www.lungusa.org/site/apps/nl/content3.asp?c=dvLUK9O0E&b=2058817&content_id={05C5FA0A-A953-4BB6-BB74-F07C2ECCABA9}¬oc=1

9. “Asthma’s Impact on Children and Adolescents.” Centers for Disease Control and Prevention. http://www.cdc.gov/asthma/children.htm