Seasonal Allergic Rhinitis - FDA Approves CLARINEX-D Gel 24 HOUR Prescription-Strength Once-Daily Nondrowsy Antihistamine

Main Category: Allergy
Article Date: 05 Mar 2005 - 11:00 PDT

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Unique Gel Control delivery system provides effective 24-hour relief - Schering-Plough Corporation (NYSE: SGP) today announced that the US Food and Drug Administration (FDA) has approved CLARINEX-D(R) 24 HOUR (desloratadine 5mg and pseudoephedrine sulfate USP 240 mg) Extended Release Tablets for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older. Available this April in time for spring allergy season, CLARINEX-D 24 HOUR will be the only once-daily prescription antihistamine and decongestant combination treatment on the market to provide 24-hour relief of nasal and non-nasal allergy symptoms.

"With the approval of CLARINEX-D 24 HOUR, physicians have a once-daily prescription allergy treatment that combines the proven efficacy and safety of CLARINEX with an established decongestant," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough.

According to a survey of 1,000 adults with allergies, 83 percent said they experience symptoms in the morning and more people indicated they suffer from nasal congestion, compared to other allergy symptoms, when they first wake up.(1)

CLARINEX-D 24 HOUR uses a Gel Control system to control the release of the pseudoephedrine component for consistent delivery. This ensures once-daily 24-hour efficacy, which allows people to wake up with their symptoms under control.

"My patients with allergies say that mornings are the toughest part of the day for dealing with their symptoms, and it often is their nasal congestion that finally makes them visit my office," said William R. Lumry, M.D. of Allergy and Asthma Specialists in Dallas, Texas. "That's why it is important for patients to have a one-dose option to help control their symptoms in the morning and all day long, even when congestion occurs."

The FDA approved CLARINEX-D 24 HOUR based on results from two 2-week randomized, parallel group clinical trials involving 2,852 patients 12 to 78 years of age with seasonal allergic rhinitis, 708 of whom received CLARINEX-D 24 HOUR. In both trials, the antihistaminic efficacy of CLARINEX-D 24 HOUR, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than pseudoephedrine or CLARINEX 5 mg alone during the treatment period. And the decongestant efficacy of CLARINEX-D 24 HOUR, when measured by nasal congestion, was significantly greater than desloratadine during the treatment period.

CLARINEX-D(R) 24 HOUR Extended Release Tablets is contraindicated in patients with narrow-angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment.

It should generally be avoided in patients with hepatic insufficiency. It should also be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Pseudoephedrine hydrochloride may produce arrhythmias and cardiovascular collapse with accompanying hypotension or central nervous system stimulation with convulsions. Care should be taken in the concomitant administration of other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.

The most commonly reported adverse events for CLARINEX-D(R) 24 HOUR Extended Release Tablets compared with desloratadine alone are dry mouth (8% vs 2%), headache (6% vs 5%), insomnia (5% vs 1%), fatigue (3% vs 3%), pharyngitis (3% vs 2%), and somnolence (3% vs 2%).

CLARINEX-D 24 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired.

About Allergies

Seasonal allergies affect an estimated 36 million people in the U.S. Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

About the CLARINEX Family

CLARINEX now is available in regular tablet, syrup and new decongestant combination tablet formulations.

CLARINEX Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older.(2)

CLARINEX Syrup provides relief from allergy symptoms caused by seasonal allergens such as ragweed, grass and tree pollens in patients 2 years of age and older and year-round allergens such as dust mites, animal dander and mold spores in patients 6 months of age and older. CLARINEX Syrup is also approved to treat the ongoing itching and rash due to hives from unknown causes in patients 6 months of age and older.(2)

Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue.(2)

Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.(2)

Please see full prescribing information at:
spfiles.com/piclarinex.pdf .

CLARINEX builds upon Schering-Plough's heritage as a leader in discovery and development. Products from the company's research efforts include the CLARITIN(R) (loratadine) family and NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg.*

About Schering-Plough Corporation

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people 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 Securities Litigation Reform Act of 1995, including the market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events and use words such as "may" and "estimate." Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering- Plough's forward-looking statements. These factors include market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, timing of trade buying, the regulatory process for new products and new indications, and matters impacting patents on Schering-Plough products. 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 the 2004 third quarter 10-Q.

References:

(1) Roper Public Affairs and Media. Assessment of morning allergy suffering among adults with allergies. An Internet survey of 1,000 adults with diagnosed allergies, 2005. Margin of error +/- 2 percentage points.

(2) CLARINEX(R) Product Information. Schering Corporation.

*Calculated on the anhydrous basis.

Schering-Plough Corporation
http://www.schering-plough.com