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Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Immunology | Pulmonary/Respiratory Diseases | Infections and Infectious Diseases

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Clarinex

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Schering-Plough
Approval Status: Approved February 2002
Treatment Area: Allergic rhinitis; Chronic ideopathic urticaria

General Information

Clarinex, in an oral tablet formulation, was approved for the treatment of seasonal allergic rhinitis (SAR)in adults and children over 12 years of age in December 2001. In February 2002, Clarinex tablets were additionally approved for the treatment of perennial allergic rhinitis (PAR) and for symptomatic relief of chronic idiopathic urticaria (CIU) in adults and children over 12 years old. Clarinex is a once-daily non-sedating antihistamine that provides 24 hour relief.

An estimated 45 million Americans are affected by allergies. Allergic rhinitis (AR) is the most common allergic disorder in the United States, affecting up to 30% of the population.SAR is considered a response to outdoor allergens, while PAR pertains to indoor allergens. AR symptoms impact daily functioning at work, school and during leisure time, resulting in millions of absentee days each year.

Urticaria, known commonly as hives, affects an estimated 20% of Americans at some point in their lives. The condition results from a reaction to a substance, most commonly food, drugs or a topical agent. Urticaria is characterized by itchy, swollen welts on the skin.

Clinical Results

Approval of Clarinex for AR treatment is supported by four double-blind, placebo-controlled studies that enrolled over 2,300 SAR sufferersand two double-blind, placebo-controlled trials with over 1,000 subjects with PAR Results show that a single 5 mg dose of Clarinex provides 24 hours of relief from nasal and non-nasal SAR symptoms. During trials, Clarinex provided significantly greater relief than placebo.

Approval for CIU is based on two double-blind, placebo-controlled studies involving 416 subjects. Treatment with Clarinex significantly reduced the severity of pruritis when compared to placebo. Clarinex also performed superior to placebo at reducing the number and size of hives.

Side Effects

Adverse events associated with the use of Clarinex may include (but are not limited to) the following:

  • Pharyngitis
  • Dry mouth
  • Nausea
  • Dizziness
  • Somnolence
  • Fatigue
  • Myalgia

Mechanism of Action

Clarinex (desloratadine) is a long-acting tricyclic histamine antagonist with selective H-1 receptor histamine antagonist activity that offers clinically proven benefits for the management of AR and CIU.

Additional Information

For additional information on Clarinex, please visit Schering-Plough.