Clinical Trial Resource Center


Clinical Trial Resource Center

FDA Approved Drugs » 2012
Medical Areas: Otolaryngology (Ear, Nose, Throat) | Pulmonary/Respiratory Diseases | Family Medicine | Infections and Infectious Diseases

View By:Year | Company | Conditions | Therapeutic Areas | Drug Names

Dymista (azelastine hydrochloride and fluticasone propionate)

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

Company: Meda Pharmaceuticals Inc
Approval Status: Approved May 2012
Treatment Area: seasonal allergic rhinitis

General Information

Dymista (azelastine hydrochloride and fluticasone propionate) is a novel formulation of azelastine hydrochloride, an antihistamine, and fluticasone propionate, a corticosteroid.

Dymista is specifically indicated for the relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.

Dymista is supplied as a sprayed suspension designed for intranasal administration. The recommended dose of Dymista is one spray per nostril twice daily. Spray should be primed once prior to administration if not used in 14 days.

Clinical Results

FDA Approval
The FDA approval of Dymista was based on the results of one long term safety study and the results of a set of three shorter-term safety studies in adults 12 years of age or older.
Two Week Trials
This series of 3 double-blind placebo-controlled studies enrolled 3411 adults with SAR for a duration of two weeks. Subjects were treated twice daily with 1 spray per nostril of Dymista Nasal Spray, azelastine hydrochloride nasal spray, fluticasone propionate nasal spray, or placebo. The azelastine hydrochloride and fluticasone propionate nasal sprays utilize the same administration vehicle and device as Dymista and are not commercially marketed. Adverse reactions in the Dymista, azelastine hydrochloride and fluticasone propionate spray treatment groups were 16%, 15% and 13%, respectively. Adverse reactions were reported in 12% of subjects in the placebo group. In both the placebo group and Dymista group, 1% of subjects discontinued use due to adverse reactions.
Twelve Month Trial
This open-label study enrolled 611 adults with perennial allergic rhinitis or vasomotor rhinitis who were grouped 2:1 to receive one spray of Dymista per nostril twice daily or two sprays of fluticasone propionate nasal spray per nostril once daily. Overall adverse reactions were 47% in the Dymista treatment arm and 44% in the fluticasone propionate treatment arm. In both groups, 3% of subjects discontinued treatment due to adverse reactions.

Side Effects

Adverse reactions associated with the use of Dymista may include, but are not limited to, the following:

  • dysgeusia
  • epistaxis
  • headache

Mechanism of Action

Dymista contains azelastine hydrochloride and fluticasone propionate, individual drugs which represent two different classes of drugs and exhibit different mechanisms of action. Azelastine hydrochloride is a a phthalazinone derivative histamine H1-receptor antagonist that demonstrates no difference in function as a racemic mixture in Dymista. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity. Fluticasone propionate is a synthetic trifluorinated corticosteroid that exhibits anti-inflammatory activity. The precise mechanism of action is not known. Corticosteroids have been shown to have a wide range of anti-inflammatory effects on multiple cell types and mediators.

Literature References

Hampel FC, Ratner PH, Van Bavel J, Amar NJ, Daftary P, Wheeler W, Sacks H Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol 2010 Aug;105(2):168-73

Additional Information

For more information regarding the use of Dymista Nasal Spray or seasonal allergic rhinitis, please visit the Meda Pharmaceuticals< web page.