KENILWORTH, New Jersey, April 27 /PRNewswire/ --

- European Commission Approves AERIUS (R) Orodispersible Tablets (2.5 mg and 5 mg) and AERIUS (R) Oral Solution (0.5 mg per 1ml)

Schering-Plough Corporation today announced the European Commission (EC) has adopted its Decisions approving AERIUS (R), AZOMYR (R), and NEOCLARITYN (R) (desloratadine) Orodispersible Tablets for the treatment of symptoms associated with allergic rhinitis and chronic idiopathic urticaria (CIU) -- hives of unknown cause -- in adults and children six years of age and older, and AERIUS, AZOMYR and NEOCLARITYN Oral Solution for the treatment of symptoms associated with allergic rhinitis and CIU in adults and children one year of age and older. The EC approval results in Marketing Authorization with unified labeling that will be valid in the current European Union (EU) 27 member states as well as in Iceland and Norway.

The new Orodispersible Tablet, which disintegrates orally, is taken once-daily for 24-hour relief, and comes in a "tutti frutti" flavor. This new formulation allows patients the option to take the product with or without water. The new formulation is available in both a 2.5 mg strength for administration of one tablet once daily for children 6 to 11 years of age and a 5 mg strength tablet for once daily administration for adults and adolescents 12 years of age and older. The new once-daily AERIUS Oral Solution is a unique sugar-free, dye-free and preservative-free formulation that provides relief of allergic rhinitis and CIU symptoms.

"It is important that physicians have allergy treatments in a variety of formulations to best suit the needs of individual patients," said Jean Bousquet, MD, PhD, Professor, Montpellier Medical School, Head, Allergy & Clinical Immunology, Montpellier University Hospital, Montpellier, France. "Convenient once-daily treatment options allow my patients to take their medicine anytime and wherever they want."

Schering-Plough markets desloratadine under the brand names AERIUS, AZOMYR and NEOCLARITYN in Europe and as CLARINEX (R) in the United States. The brands build upon Schering-Plough's heritage as a leader in discovery and development. Additional products from the company's research efforts include the CLARITIN(R) (loratadine) family of nonsedating antihistamines and NASONEX (R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg.

About Allergic Rhinitis

Symptoms of allergic rhinitis may include sneezing, congestion, itchy and runny nose, and itchy, redness and/or watery eyes.(1) Symptoms can have an impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to a possible association between allergies and other respiratory conditions, such as asthma.(1)

Survey data show that symptoms are most severe in the morning, and about two-thirds of respondents reported that morning suffering affects the rest of the day.(2) Allergy sufferers should minimize early morning activity when pollen is usually emitted -- between 5 a.m. and 10 a.m.(3)

The survey also showed that even though allergies are frequently a self-diagnosed condition, patients rely on medical experts to help properly manage their symptoms.(2)

About AERIUS

AERIUS (desloratadine) is a nonsedating prescription antihistamine for the treatment of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria (CIU) -- hives of unknown cause. AERIUS Tablets is approved to treat symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis) and CIU in patients 12 years of age and older. Now, AERIUS Orodispersible Tablets 2.5 mg and 5 mg are approved to treat these symptoms in patients 6 years of age and older.(4) AERIUS Syrup and now AERIUS Oral Solution are both approved to treat these symptoms in patients 1 year of age and older.(4)

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache.(4) In clinical trials in a pediatric population (children aged 6 months through 11 years), the overall incidence of adverse events in children 2 through 11 years of age was similar for the AERIUS syrup and placebo groups.(4) In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhea, fever and insomnia.(4)

Research shows AERIUS provides powerful morning symptom relief. In a study of 346 people with moderate-to-severe seasonal allergic rhinitis, patients receiving AERIUS experienced significant improvement in morning scores versus placebo for both nasal and non-nasal symptoms.(5) AERIUS offers demonstrated efficacy at the end of the dosing interval.(4) AERIUS also has a half-life of approximately 27 hours.(4)

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 approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

    
    References:
    1. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket
       Guide.  2001.
    2. "Understanding the Dynamics Surrounding Allergy Suffering and
       Treatment" Forbes Consulting Group. 2005.
    3. "Tips to Remember: Outdoor Allergens." American Academy of Allergy,
       Asthma and Immunology. 6 Nov. 2006
       www.aaaai.org/patients/publicedmat/tips/outdoorallergens.stm .
    4. AERIUS [NEOCLARITYN] (summary of product characteristics). Schering
       Corporation.
    5. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group.
       Efficacy and tolerability of once-daily 5mg desloratadine, and H1-
       receptor antagonist, in patients with seasonal allergic rhinitis:
       assessment during the spring and fall allergy seasons. Clin Drug
       Invest. 2001; 21:25-32.

Web site: www.schering-plough.com

Source: Schering-Plough Corporation