Meda's Dymista approved as treatment for seasonal allergy symptoms
Wednesday, May 02 2012 | Comments
The Food and Drug Administration
approved Meda AB
's Dymista (fluticasone propionate/azelastine hydrochloride) nasal spray for the treatment of seasonal allergic rhinitis (SAR).
Specifically, the spray, which is administered twice-daily in each nostril, is approved for the relief of SAR symptoms in patients aged 12 years or older who require treatment with both of the drug's active ingredients to achieve symptomatic relief.
According to Meda, the efficacy and safety of Dymista have been established in multiple studies involving more than 4,000 patients, including a long-term safety study that included more than 600 patients. In multiple studies, the company added, the spray "consistently showed rapid and more complete symptom relief than standard treatment."
Last June, Meda reported data from three Phase III randomized trials--MP4001, MP4002 and MP4004--that included more than 2,200 patients. The combined trial data indicated that Dymista is more effective as a treatment for allergic rhinitis than nasal sprays containing either of the individual ingredients alone.
Meda said that Dymista would be available in the United States in the second half of this year.
Fluticasone propionate nasal spray is available as GlaxoSmithKline Plc
's Flonase, and azelastine hydrochloride nasal spray is available as Meda's Astelin and Astepro. Both drugs are also available as generics.