Clinical Trials | DYMISTA (azelastine HCl/fluticasone propionate) Nasal Spray for Seasonal Nasal Allergies

In Patients 12 years and older, 3 pivotal clinical studies of total nasal symptom scores showed

Superior efficacy

vs azelastine HCI or fluticasone propionate comparators

Dymista demonstrated significantly greater improvement in reflective total nasal symptom relief in patients 12 years and older.^1-3

The azelastine HCI and fluticasone propionate comparators used the same device and vehicle as Dymista and are not commercially marketed.¹

Study objective

Data shown are from pivotal study MP 4004. Across all 3 pivotal clinical trials, Dymista provided a significant improvement in rTNSS, ranging from 43% to 67% relative to azelastine HCI or fluticasone propionate comparators, as presented in the Full Prescribing information.^1-3

Change from baseline in the placebo-subtracted mean rTNSS for each day (maximum score 24), averaged over the 14-day study period. Percent difference represents the improvement in rTNSS with Dymista relative to azelastine HCI or fluticasone propionate comparators.^1-3

References: 1. Dymista [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc., a Mylan Company; 2015. 2. Data on file. Meda Pharmaceuticals Inc., a Mylan Company. 3. Carr W, Bernstein J, Lieberman P, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012;129(5):1282-1289.e10.

More IMPORTANT SAFETY INFORMATION

Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA.

Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with DYMISTA because further decreased alertness and impairment of CNS performance may occur.

Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.

Glaucoma or posterior subcapsular cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.

Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DYMISTA slowly.

Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving DYMISTA.

Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate.

Ritonavir: Coadministration is not recommended.

Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.

The most common adverse reaction (≥2% incidence) are dysgeusia, epistaxis, and headache.

INDICATIONS

DYMISTA contains an H1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptom relief.

Superior efficacy

vs azelastine HCI or fluticasone propionate comparators

More IMPORTANT SAFETY INFORMATION

INDICATIONS

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