DuleraTreatment for Asthma
Update: Dulera (mometasone furoate/formoterol fumarate) Now FDA Approved - June 22, 2010
NDA Submitted for Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
KENILWORTH, N.J., July 22 /PRNewswire-FirstCall/ -- Schering-Plough today announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate has been filed in the United States and accepted for review by the U.S. Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA of the mometasone furoate/formoterol fumarate combination for the maintenance treatment of asthma in patients 12 years of age and older.
Mometasone furoate/formoterol fumarate combines the active ingredients of an inhaled corticosteroid, Asmanex (mometasone furoate inhalation powder), with the long-acting beta2-agonist, Foradil (formoterol fumarate inhalation powder), administered via a single metered-dose inhaler. Schering-Plough has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol furmarate fixed-dose combination.
"We are pleased to announce the U.S. filing of the fixed-dose combination of mometasone furoate and formoterol fumarate," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "If approved by the FDA, the mometasone fuorate/formoterol combination would represent an important additional treatment option for physicians and their patients and further strengthen Schering-Plough's portfolio of respiratory products."
Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and chronic obstructive pulmonary disease (COPD) medications, in terms of dollar sales (1). The fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma in patients younger than 12 years of age and for use in COPD is currently in Phase III development.
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, animal health and consumer health care 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 www.schering-plough.com.
Asthma is a chronic lung disease 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.(2) Asthma symptoms can be triggered by allergens or irritants and can include difficulty breathing, wheezing, coughing, shortness of breath and tightness in the chest.(2) With more than 22 million people living with asthma in the United States(3), it is one of the most common and costly chronic diseases.(2) Annually, this disease leads to almost two million asthma-related emergency room visits and more than 4,000 asthma-related deaths in the United States.(2) There is no cure for asthma, but asthma can be managed with proper treatment.(2)
Asmanex Twisthaler (mometasone furoate inhalation powder) is for the maintenance treatment of asthma in patients 4 years of age and older. Asmanex Twisthaler will not relieve sudden asthma symptoms and is not for children under the age of 4.
Asmanex Twisthaler is available in two dose strengths, 110 mcg for children between 4 and 11 years old, and 220 mcg for patients 12 and older.
Important Safety Information for Asmanex Twisthaler
Asmanex Twisthaler 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 greater than or equal to 12 years old include headache, allergic rhinitis, sore throat, and upper respiratory infection.
Please see additional important product information for Asmanex Twisthaler.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088
Foradil Aerolizer is for the maintenance treatment of asthma in those 5 years and older when taken on a long-term, twice-daily basis. Foradil Aerolizer should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.
Foradil Aerolizer is not indicated for patients whose asthma can be managed by occasional use of fast-acting rescue inhalers. Foradil Aerolizer is also for the acute prevention of exercise-induced bronchospasm (EIB) in those 5 years of age and older when administered on an occasional, as-needed basis at least 15 minutes before exercise.
Foradil Aerolizer is for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.
Important Safety Information for Foradil Aerolizer
Foradil belongs to a class of medications known as long-acting beta2-adrenergic agonists or LABAs. In patients with asthma, LABAs may increase the chance of asthma related death. Therefore, Foradil should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.
In asthma clinical trials, the most common adverse events reported with Foradil Aerolizer were viral infection, bronchitis, and chest infection.
In COPD clinical trials, the most common adverse events reported with Foradil Aerolizer were upper respiratory infection, back pain, and sore throat.
Foradil capsules should only be inhaled orally using the Aerolizer inhaler. The capsules should not be swallowed.
Foradil Aerolizer should not be used to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Do not use more than one capsule twice daily. Foradil Aerolizer should be used with caution in patients with cardiovascular disorders. Foradil Aerolizer is not a substitute for inhaled or oral corticosteroids and, in the treatment of asthma, they should not be stopped or reduced at the time Foradil Aerolizer is initiated.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see additional important product information for Foradil Aerolizer.
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 the potential market for investigational mometasone furoate/formoterol fumarate MDI. 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 Item 1A. "Risk Factors" in Schering-Plough's first quarter 2009 10-Q, filed May 1, 2009
1. IMS Midas data, 2003-2008.
2. "Asthma Facts and Figures." Asthma and Allergy Foundation of America, 2005. Available at: http://www.aafa.org/display.cfm?id=8?=42.
3. "What is asthma?" National Heart Lung and Blood Institute. National Institutes of Health, September 2008. Available at http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html
Source: Schering-Plough Corporation
CONTACT: Media, Julie Lux, +1-908-298-4774, or Investors, Janet M. Barth
or Joe Romanelli, +1-908-298-7436, all of Schering-Plough Corporation
Web Site: http://www.schering-plough.com/
Posted: July 2009
- FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older - June 24, 2010