Schering-Plough announces European approval of new formulations of AERIUS (Desloratadine)

Apr 30 2007

European Commission approves AERIUS Tablets (2.5 mg and 5 mg) and AERIUS Oral Solution (0.5 mg per 1ml).

Schering-Plough Corporation has announced the European Commission (EC) has adopted its Decisions approving AERIUS, AZOMYR, and NEOCLARITYN (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 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 (loratadine) family of nonsedating antihistamines and NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg.

Symptoms of allergic rhinitis may include sneezing, congestion, itchy and runny nose, and itchy, redness and/or watery eyes. 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.

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. Allergy sufferers should minimize early morning activity when pollen is usually emitted -- between 5 a.m. and 10 a.m.

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.