Meda's MP29-02 (Dymista) was found to be well tolerated and effective in three clinical trials conducted in patients with chronic allergic or non-allergic rhinitis.
MP29-02 is an intranasal formulation of azelastine hydrochloride and fluticasone propionate, and is under review by the US Food and Drug Administration (FDA) for the treatment of seasonal allergic rhinitis (SAR).
In the randomised open-label active-controlled parallel-group first study, 612 patients were treated with either MP29-02 one spray per nostril twice daily or fluticasone propionate two sprays per nostril once daily.
During the one-year period, the study evaluated safety and tolerability, and also assessed efficacy by measuring the 12-hour reflective total nasal symptom score (rTNSS) scored once daily.
The first study demonstrated that continuous treatment with MP29-02 was well tolerated and showed greater relief from nasal symptoms than fluticasone-treated patients over the one-year study period.
Lead author of the first study William Berger said: "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."
The randomised double-blind placebo and active controlled two week pivotal trials, MP4002 and MP4004, conducted in more than 1600 patients with moderate-to-severe SAR evaluated MP29-02 for the treatment of ocular symptoms associated with SAR, a key secondary endpoint in the MP29-02 clinical development programme.
The primary endpoint of the trials was change from baseline in the 12-hour reflective total nasal symptom score (rTNSS), and the secondary endpoint was the 12-hour reflective total ocular symptom score (rTOSS), including itchy eyes, watery eyes, and eye redness.
In the second and third studies, patients with SAR demonstrated considerable relief from nasal symptoms and also improved TOSS compared to placebo over a two-week study period.
Meda CEO Anders Lönner said: "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."