Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
KENILWORTH and WHITEHOUSE STATION, N.J., Aug. 28 -- Schering-Plough/Merck Pharmaceuticals (SPM) today 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 and Merck & Co., Inc. .
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.
About Allergic Rhinitis
Allergic rhinitis affects more than 50 million people in the United States (1,2) and accounts for more than 14 million physician office visits each year.(3) It is one of the most costly chronic illnesses in the United States (4) and is estimated to cause 100 million days of lost work per year.(5)
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.(6)
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.(7) 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.(8)
In clinical trials, side effects were similar to placebo and included headache, fatigue and dry mouth. In clinical trials supporting the NDA, the combination product provided a consistent and clinically relevant effect on congestion that was not demonstrated with the individual components.
Schering-Plough received U.S. Food and Drug Administration (FDA) approval on November 27, 2002, for the over-the-counter (OTC) sale of the original prescription strength of CLARITIN Tablets.
SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. In clinical studies for both SAR and PAR, SINGULAIR was generally well tolerated. Adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased ALT. SINGULAIR is contraindicated in patients with hypersensitivity to any of its components.
About Schering-Plough/Merck Pharmaceuticals
Schering-Plough/Merck Pharmaceuticals is a joint venture between Schering- Plough Corporation and Merck & Co., Inc. formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast.
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 loratadine/montelukast. 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 and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in the company's second quarter 2007 10-Q.
Merck forward-looking statement: This press release contains "forward- looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.