Date: 2012-03-05
Type of information:
phase:
Announcement: results
Company: Meda (Sweden)
Product: Dymista® MP29-02
Action mechanism: MP29-02 (tentatively called Dymista®) is an intranasal formulation of azelastine hydrochloride and fluticasone propionate.
Disease: seasonal allergic rhinitis
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details: Long-Term Safety Study: In study MP4000, presented by Dr. Berger, the long-term safety of MP29-02 was evaluated in 612 patients with chronic allergic or non-allergic rhinitis over the course of one year. In this randomized, open-label, active-controlled, parallel-group study, patients were treated with either MP29-02 one spray per nostril twice daily (total daily doses of azelastine and fluticasone were 548 mcg and 200 mcg, respectively) or fluticasone propionate two sprays per nostril once daily (total daily dose 200 mcg). Safety and tolerability assessments were conducted at regular intervals during the one-year study and efficacy was assessed as a secondary endpoint by the 12-hour reflective total nasal symptom score (rTNSS) scored once daily in the evening each day of the study.
Latest
news: * On March 5, 2012, Meda has announced 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 FDA for the treatment of SAR.Long-Term Safety Study: In study MP4000, patients were treated with either MP29-02 one spray per nostril twice daily (total daily doses of azelastine and fluticasone were 548 mcg and 200 mcg, respectively) or fluticasone propionate two sprays per nostril once daily (total daily dose 200 mcg). Safety and tolerability assessments were conducted at regular intervals during the one-year study and efficacy was assessed as a secondary endpoint by the 12-hour reflective total nasal symptom score (rTNSS) scored once daily in the evening each day of the study. The results showed that MP29-02 was well tolerated. The most common treatment-related adverse events were headache in 4.3 percent of patients taking fluticasone and dysgeusia in 2.5 percent of patients taking MP29-02. There were no clinically relevant nasal examination findings, in particular no evidence of nasal ulceration or perforations in either group. Ocular examinations were also unremarkable. No appreciable changes in laboratory values were observed during the study and there were no significant changes from baseline in serum cortisol levels in either treatment group.In addition, based on the rTNSS, the efficacy of MP29-02 was sustained over the one-year duration of the study.Ocular Symptoms Studies: In an analysis of two pivotal studies (MP4002 and MP4004), presented by Dr. Ratner, MP29-02 was evaluated for the treatment of ocular symptoms associated with SAR, a key secondary endpoint in the MP29-02 clinical development program. These key clinical efficacy and safety studies of MP29-02 were randomized, double-blind, placebo- and active-controlled two week trials conducted in more than 1600 patients with moderate-to-severe SAR. While the primary endpoint was change from baseline in the 12-hour reflective total nasal symptom score (rTNSS), the key secondary endpoint was the 12-hour reflective total ocular symptom score (rTOSS), consisting of itchy eyes, watery eyes, and eye redness. All patients were treated with one spray per nostril twice daily using the same vehicle and delivery device.In addition to more effective relief of nasal symptoms, results demonstrated MP29-02 significantly (P<.05) improved the total ocular symptom score (TOSS) compared to placebo. In a post-hoc analysis, significantly (P<.05) more patients treated with MP29-02 experienced a clinically important 50 percent improvement in ocular symptoms than patients treated with fluticasone or azelastine in study MP 4004, and, in a second post-hoc analysis, MP29-02 appeared to be particularly effective in patients with more severe symptoms. MP29-02 was well tolerated in these two-week studies and the incidence of adverse events in the MP29-02 group generally was similar to the azelastine and fluticasone treatment groups.
