Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Immunology | Pulmonary/Respiratory Diseases | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved February 2002
Treatment Area: Allergic rhinitis; Chronic ideopathic urticaria
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
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.
Adverse events associated with the use of Clarinex may include
(but are not limited to) the following:
- Dry mouth
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.