Meda has announced positive results from three studies of its Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. The company filed both an NDA for the product, currently known as MP29-02, and an MAA in 2011. One long-term study showed that the product is well tolerated, with fewer than 3% of patients dropping out due to an adverse event after continuous treatment for a year and that patients using MP29-02 got better relief from nasal symptoms than those treated with fluticasone alone. The other two studies showed improved relief from symptoms over the individual components and placebo and significantly greater improvement in ocular symptoms compared to placebo over a 2-week period.
“These data show support for the safety and efficacy of this novel nasal spray formulation, especially for patients who have persistent symptoms of seasonal allergic rhinitis that may require longer-term treatment,” commented the lead author of the long-term study, William E. Berger of Asthma & Allergy Associates of Southern California.
Meda CEO Anders Lönner commented, “We are very pleased about the continuous flow of strong results from our Phase III pivotal studies supporting the unique clinical profile of Dymista. These data provide additional important evidence that Dymista can offer significant benefits to patients and may play a critical role in the future treatment of patients with SAR.”
Read the Meda press release.
