KENILWORTH, New Jersey, April 27 /PRNewswire/ --
- European Commission Approves AERIUS (R) Orodispersible Tablets (2.5 mgand 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 symptomsassociated 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 ofsymptoms associated with allergic rhinitis and CIU in adults and children oneyear of age and older. The EC approval results in Marketing Authorizationwith 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 takenonce-daily for 24-hour relief, and comes in a "tutti frutti" flavor. This newformulation allows patients the option to take the product with or withoutwater. The new formulation is available in both a 2.5 mg strength foradministration of one tablet once daily for children 6 to 11 years of age anda 5 mg strength tablet for once daily administration for adults andadolescents 12 years of age and older. The new once-daily AERIUS OralSolution is a unique sugar-free, dye-free and preservative-free formulationthat provides relief of allergic rhinitis and CIU symptoms.
"It is important that physicians have allergy treatments in a variety offormulations to best suit the needs of individual patients," said JeanBousquet, 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 theirmedicine 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 anddevelopment. Additional products from the company's research efforts includethe 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 andrunny nose, and itchy, redness and/or watery eyes.(1) Symptoms can have animpact on everyday activities at work, school and leisure time. There also isa growing body of evidence that points to a possible association betweenallergies and other respiratory conditions, such as asthma.(1)
Survey data show that symptoms are most severe in the morning, and abouttwo-thirds of respondents reported that morning suffering affects the rest ofthe day.(2) Allergy sufferers should minimize early morning activity whenpollen is usually emitted -- between 5 a.m. and 10 a.m.(3)
The survey also showed that even though allergies are frequently aself-diagnosed condition, patients rely on medical experts to help properlymanage their symptoms.(2)
About AERIUS
AERIUS (desloratadine) is a nonsedating prescription antihistamine forthe treatment of symptoms associated with allergic rhinitis (includingintermittent and persistent allergic rhinitis) and chronic idiopathicurticaria (CIU) -- hives of unknown cause. AERIUS Tablets is approved totreat symptoms of allergic rhinitis (including intermittent and persistentallergic rhinitis) and CIU in patients 12 years of age and older. Now, AERIUSOrodispersible Tablets 2.5 mg and 5 mg are approved to treat these symptomsin patients 6 years of age and older.(4) AERIUS Syrup and now AERIUS OralSolution are both approved to treat these symptoms in patients 1 year of ageand older.(4)
The most common side effects in adults and adolescents with allergicrhinitis and CIU were fatigue, dry mouth and headache.(4) In clinical trialsin a pediatric population (children aged 6 months through 11 years), theoverall incidence of adverse events in children 2 through 11 years of age wassimilar for the AERIUS syrup and placebo groups.(4) In infants and toddlersaged 6 to 23 months, the most frequent adverse events reported in excess ofplacebo were diarrhea, fever and insomnia.(4)
Research shows AERIUS provides powerful morning symptom relief. In astudy of 346 people with moderate-to-severe seasonal allergic rhinitis,patients receiving AERIUS experienced significant improvement in morningscores versus placebo for both nasal and non-nasal symptoms.(5) AERIUS offersdemonstrated efficacy at the end of the dosing interval.(4) AERIUS also has ahalf-life of approximately 27 hours.(4)
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company withleading prescription, consumer and animal health products. Through internalresearch and collaborations with partners, Schering-Plough discovers,develops, manufactures and markets advanced drug therapies to meet importantmedical needs. Schering-Plough's vision is to earn the trust of thephysicians, patients and customers served by its approximately 33,500 peoplearound the world. The company is based in Kenilworth, N.J., and its Web siteis http://www.schering-plough.com.a>
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 http://www.aaaai.org/patients/publicedmat/tips/outdoorallergens.stma> . 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: http://www.schering-plough.com
Schering-Plough Corporation
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