New Combo Allergy Drug Approved by FDA


May 03, 2012

May 3, 2012 —The US Food and Drug Administration (FDA) approved a new combination drug for seasonal allergies on Tuesday that spares patients from having to take its 2 components separately.

Dymista (Meda Pharmaceuticals) nasal spray combines fluticasone propionate (Flonase, GlaxoSmithKline) and azelastine hydrochloride (Astepro, Astelin, Meda Pharmaceuticals). It is indicated for patients 12 years of age and older with seasonal allergic rhinitis (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.

Warner Carr, MD, principal investigator in the clinical development of the drug, said in a Meda Pharmaceutical press release that “Dymista has the potential to help reduce the number of allergy medications patients may need to take and offers greater efficacy than traditional first-line agents, which in turn can lead to greater compliance and more efficient use of health system resources.”

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.

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 can be found on the FDA Web site.


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