FDA Approves CLARINEX-D(R) 12 HOUR (desloratadine 2.5mg/pseudoephedrine 120mg) Tablet Prescription Antihistamine With Decongestant

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Respiratory / Asthma;  Immune System / Vaccines
Article Date: 06 Feb 2006 - 13:00 PDT

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Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved CLARINEX-D® 12 HOUR (desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) Extended Release Tablets for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.

CLARINEX-D 12 HOUR will be available nationwide in March 2006, in time for the spring allergy season. The new treatment option addresses an important need for allergy sufferers, who indicate that nasal congestion is the most bothersome symptom of allergic rhinitis.(1) In addition, a survey of 1,000 adults with allergic rhinitis found nearly 85 percent experience nasal congestion when they first wake up, making it the most prevalent allergy symptom in the morning.(2)

"For my patients who report nasal congestion along with other allergy symptoms, an antihistamine and decongestant combination treatment provides safe and effective relief," said William Lumry, M.D., Allergy & Asthma Specialists, Dallas, Texas. "With CLARINEX-D 12 or 24 hour extended release tablets, I can now prescribe a 12- or 24-hour formulation that does not cause drowsiness and treats their nasal blockage effectively."

The new formulation uses a bi-layer tablet delivery system, which controls the release of the pseudoephedrine component for consistent delivery. The recommended twice-daily dosing of CLARINEX-D 12 HOUR will help patients control their nasal congestion, along with their sneezing, runny nose, itchy throat, or itchy and watery eyes, in the morning and throughout the day.

"Physicians now have a 12-hour formulation 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. "CLARINEX-D 12 HOUR provides physicians with another option for tailoring allergy treatment regimens based on patients' specific symptoms and needs."

The FDA approved CLARINEX-D 12 HOUR based on results from two clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received CLARINEX-D 12 HOUR. In both 2-week randomized, parallel group trials, the antihistaminic efficacy of CLARINEX-D 12 HOUR, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than that of pseudoephedrine alone during the treatment period. And the decongestant efficacy of CLARINEX-D 12 HOUR was significantly greater than that of desloratadine alone during the treatment period, based on nasal congestion scores. As the data show, CLARINEX-D 12 HOUR effectively treats nasal congestion, the most bothersome symptom of allergic rhinitis, in addition to relieving other nasal and non-nasal symptoms of allergic rhinitis.

The most commonly reported adverse events for CLARINEX-D 12 HOUR Extended Release Tablets compared with desloratadine alone are insomnia (10% vs. 3%), headache (8% vs. 8%), dry mouth (8% vs. 2%), fatigue (4% vs. 2%), somnolence (3% vs. 4%), pharyngitis (3% vs. 3%) and dizziness (3% vs. 2%).

CLARINEX-D 12 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.(3) There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.(4)

About the CLARINEX Family of Products

CLARINEX is the only branded prescription allergy treatment available in this diverse variety of formulations. CLARINEX® (desloratadine) 5 mg Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older. CLARINEX RediTabs® (desloratadine) 2.5 orally-disintegrating tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 6 years of age and older; a 5mg RediTabs tablet is available for patients 12 years and older. CLARINEX Syrup (desloratadine) 0.5 mg per 1 mL, available in a bubblegum flavor, is approved for the relief of symptoms of outdoor allergies in children 2 years and older, and indoor allergies and hives of unknown cause in children as young as 6 months. (5) CLARINEX-D® 24 HOUR (desloratadine 5 mg/pseudoephedrine USP 240 mg) Extended Release Tablets is a once-daily prescription antihistamine and decongestant combination treatment which provides 24-hour relief of nasal and non-nasal symptoms of outdoor allergies in patients 12 years of age and older.(6)

CLARINEX 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. 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.(5)

Due to its pseudoephedrine component, CLARINEX-D 12 Hour Extended Release Tablets should not be taken by patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, severe high blood pressure, or severe heart disease, or by patients who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen (14) days. Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver or kidney problems; or enlarged prostate should check with their healthcare provider before taking CLARINEX-D 12 HOUR. Care should be used if CLARINEX-D 12 HOUR is taken with other antihistamines or decongestants because combined effects on the cardiovascular system may be harmful. The most commonly reported adverse events for CLARINEX-D 12 HOUR Extended Release Tablets were, insomnia, headache, dry mouth, fatigue, drowsiness, sore throat, and dizziness.(7)

Visit www.CLARINEX.com for more information on preventing and treating seasonal nasal allergies. For additional important safety information, full prescribing information is available at: www.spfiles.com/piclarinex.pdf.

SSCHERING-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 statements related to CLARINEX and the potential market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statements. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these or other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.

References:
1. Roper Public Affairs and Media. Impact of nasal congestion among allergic rhinitis sufferers, 2004.
2. Roper Public Affairs and Media. Assessment of morning allergy suffering among adults with allergies, 2005.
3. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy Report, 2000.
4. Linneberg A, Henrik Nielsen N, Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study,. Allergy 2002; 57: 1048-52.
5. CLARINEX(R) Tablets, Syrup and RediTabs Product Information. Schering Corporation.
6. CLARINEX-D(R) 24 HOUR Product Information. Schering Corporation.
7. CLARINEX-D(R) 12 HOUR Product Information. Schering 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., USA.

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