Schering-Plough/Merck Pharmaceuticals (SPM) announced that the New Drug Application filing for loratadine/montelukast has been accepted by the U.S. Food and Drug Administration (FDA) for standard review.
Schering-Plough/Merck Pharmaceuticals is seeking U.S. marketing approval of loratadine/montelukast for treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion. If approved the medicine would be marketed as a prescription treatment by Schering-Plough/Merck Pharmaceuticals, a joint venture between Schering-Plough Corporation (NYSE: SGP) and Merck & Co., Inc. (NYSE: MRK) .
The medicine is a single tablet that contains the active ingredients of CLARITIN (R) (loratadine) and SINGULAIR (R) (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.
Allergic rhinitis affects more than 50 million people in the United States and accounts for more than 14 million physician office visits each year. It is one of the most costly chronic illnesses in the United States and is estimated to cause 100 million days of lost work per year.
There are two forms of allergic rhinitis: seasonal and perennial. Seasonal allergic rhinitis occurs only during certain times of the year and is commonly caused by allergies to tree, grass and weed pollen (often referred to as “hay- fever”). Perennial allergic rhinitis tends to last throughout the year and is caused by continuous exposure to allergens such as animal dander, indoor mold spores or house dust mites.
Allergic rhinitis is activated when the immune system comes in contact with an allergen, such as dust, dander or pollen, and mistakenly identifies it as an intruder. An allergic reaction results, involving the body’s release of various inflammatory mediators, including histamine and leukotrienes, as a defense against the allergens, causing symptoms such as sneezing, nasal congestion, runny nose, and itching of the palate, eyes and nose.