FDA Approvals: New Combo Nasal Spray for Seasonal Allergies

Clinical Context

The US Food and Drug Administration (FDA) approved a new combination nasal spray for seasonal allergic rhinitis (SAR), which will alleviate the need for patients requiring both components to take them separately. Clinical trials leading to approval showed that the combination of fluticasone and azelastine was significantly more effective than each of the 2 drugs given alone for relieving rhinorrhea, nasal congestion, sneezing, and nasal itching. Another advantage is early onset of action, occurring 30 minutes after the initial dose.
Study Synopsis and Perspective

The FDA approved a new combination drug for seasonal allergies that spares patients from having to take its 2 components separately.

Dymista nasal spray combines fluticasone propionate (Flonase) and azelastine hydrochloride (Astepro, Astelin). It is indicated for patients 12 years of age and older with SAR who require both drugs for symptom relief.

In 3 clinical trials involving 853 patients with SAR, the combination of fluticasone and azelastine significantly outperformed each of the 2 drugs by itself as well as a placebo in relieving rhinorrhea, nasal congestion, sneezing, and nasal itching, according to the drug’s FDA-approved label. “Onset of action was observed as early as 30 minutes following the initial dose,” the label states.

A spokesperson for the Asthma and Allergy Foundation of America emailed Medscape Medical News that “this new nasal spray combination of 2 proven therapies into one will be welcome news for many doctors and their patients.”

The “Warnings and Precautions” section of the drug’s label lists risks commonly associated with antihistamines and corticosteroids, more so with the latter. These risks include the development of glaucoma or posterior subcapsular cataracts and hypercorticism and adrenal suppression. Clinicians should use caution prescribing the drug to patients with tuberculosis, ocular herpes simplex, and other infections because the drug could cause these conditions to worsen. Patients should be monitored for adverse effects on the nasal mucosa. And pediatric patients should be watched for a possible slowdown in growth.

The common adverse reactions during the clinical trials were a metallic taste in the mouth, nosebleeds, and headache, according to the FDA.

Dosage and Administration

The fluticasone-azelastine combination is for intranasal use only. Each 0.137-mL spray contains 137 µg of azelastine hydrochloride and 50 µg of fluticasone propionate. For adults and adolescents 12 years and older, the recommended dose is 1 spray per nostril twice daily. The spray pump should be primed before first use and when it has not been used for 14 or more days.

Other Warnings and Precautions

Because of possible somnolence, patients taking the nasal spray should avoid driving, operating machinery, or participating in other potentially hazardous activities requiring complete mental alertness. They should also avoid concurrent use of alcohol or other central nervous system depressants.

Patients should be periodically monitored for signs of adverse effects on the nasal mucosa, such as nosebleeds, nasal ulcerations, nasal septal perforation, impaired wound healing, and Candida albicans infection. The nasal spray should be avoided in patients with recent nasal ulcers, nasal surgery, or nasal trauma.

Patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts should be closely monitored.

The nasal spray may be associated with potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex; or chickenpox or measles.

At very high dosages or at the regular dosage of the fluticasone-azelastine nasal spray in susceptible individuals, hypercorticism and adrenal suppression may occur. If so, the nasal spray should then be slowly discontinued.

Use in Special Populations

The fluticasone-azelastine nasal spray is pregnancy category C and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Although there are no adequate and well-controlled clinical trials of the nasal spray or its components, animal reproductive studies of azelastine hydrochloride and fluticasone propionate showed evidence of teratogenicity as well as other developmental toxic effects.

Because many drugs are excreted in human milk, caution is recommended when the nasal spray is given to a breast-feeding woman, although it is unknown whether this drug is excreted in human breast milk.

In children younger than 12 years, safety and effectiveness of the fluticasone-azelastine nasal spray have not been determined. Clinical trials did not include enough patients at least 65 years old to determine whether they respond differently than younger patients. However, cautious dose selection is recommended for elderly patients, usually starting at the low end of the dosing range, because of increased likelihood of reduced hepatic, renal, or cardiac function, and of comorbid conditions or other drug treatment.

Meda Pharmaceutical said the drug will become available in the United States in the second half of 2012.

More information on the combination fluticasone-azelastine drug is available on the FDA Web site.
Clinical Implications

A new combination nasal spray approved by the FDA contains fluticasone propionate and azelastine hydrochloride, eliminating the need to use these drugs separately. It is indicated for patients who are at least 12 years old and who require both drugs for symptom relief of SAR. It is intended for intranasal use only, at a recommended dose of 1 spray per nostril twice daily.
Risks associated with use of combination fluticasone-azelastine nasal spray include those commonly associated with antihistamines and corticosteroids. These include development of glaucoma or posterior subcapsular cataracts; hypercorticism and adrenal suppression; adverse effects on the nasal mucosa; and possible worsening of tuberculosis, ocular herpes simplex, and other infections. Common adverse effects include metallic taste in the mouth, nosebleeds, and headache.
The combination fluticasone-azelastine nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is recommended when the nasal spray is given to a breast-feeding woman.