Meda (STO:MEDAA) announced today positive results of three studies of MP29-02 (tentatively called Dymista), a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate. The first study demonstrated that continuous treatment with MP29-02 for 1 year was well tolerated in patients with chronic allergic or non-allergic rhinitis, only 2.7% of patients treated with MP29-02 and 2.9% of patients treated with fluticasone propionate discontinued the study due to an adverse event. MP29-02 also provided sustained efficacy over the one-year study period. MP29-02-treated patients experienced consistently greater relief from their nasal symptoms than fluticasone treated patients over the course of the study. Statistically significant (P<.05) differences favoring MP29-02 over fluticasone were observed at months 1 through 7 and at months 9 and 11.
The second and third studies in patients with seasonal allergic rhinitis (SAR) provided evidence that MP29-02 demonstrated significantly more effective relief of nasal symptoms (P<.05 vs. azelastine, fluticasone, and placebo) and significantly greater ocular benefits compared to placebo (P<.05) over a 2-week study period. The new data was the subject of platform presentations on Sunday, March 4, 2012 at the annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in Orlando, Florida. MP29-02 is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of SAR.
"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," said William E. Berger, MD, FAAAAI, FACAAI, Asthma & Allergy Associates of Southern California, lead author of the first study.
In the United States, ocular symptoms linked to allergies, also known as "allergic conjunctivitis" or "ocular allergy", are known to affect more than 20 percent of the population[i] and can have a negative effect on visual function, daily activities, and quality of life. It is common for patients with allergic rhinitis to suffer from bothersome ocular symptoms in addition to nasal symptoms, with a high prevalence and pattern that correlate with season, region, and environmental triggers.
"In addition to nasal congestion, runny nose and sneezing, ocular symptoms such as watering and red, itchy eyes are particularly prevalent in seasonal allergic rhinitis sufferers and can be extremely irritating and distressing", said Paul H. Ratner, M.D., M.B.A., Sylvana Research, San Antonio, TX, principal investigator and lead author of the second and third studies. "The potential for more complete relief of the constellation of symptoms would represent a significant benefit to patients and a major advance in the treatment of seasonal allergic rhinitis."