7:01AM Horizon Pharma begins initial commercial launch of RAYOS delayed-release tablets in the United States (HZNP) 2.59 : Co announces that RAYOS delayed release tablets are now available to U.S. physicians to treat a broad range of diseases, including rheumatoid arthritis, polymyalgia rheumatic, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease. The focus of the commercial launch will be in rheumatologic diseases, such as RA and PMR. The co will initially target ~1000 rheumatologists in the U.S. with thirteen rheumatology sales specialists. The full launch to the majority of U.S. rheumatologists and high-value primary care physicians with Horizon's entire sales force of ~150 representatives will begin in late January 2013.
Specific results from CAPRA-2 demonstrated:
A statistically significant improvement in ACR20 response criteria, the primary study endpoint, for patients who were treated with RAYOS compared to the placebo group (47% vs. 29%).
A statistically significant improvement in ACR50 response compared to placebo (22% vs. 10%) and an improvement in the more stringent ACR70 response criteria (7% vs. 3%). Both ACR50 and ACR70 were pre-specified secondary endpoints.
The relative change from baseline in the duration of morning stiffness at 12 weeks was assessed as a pre-specified secondary endpoint. Patients treated with RAYOS had a median decrease in the duration of morning stiffness of 55 minutes compared to 33 minutes in placebo-treated patients (20 minute estimated median difference between treatment groups with 95% confidence interval.
The safety of RAYOS was based on the evaluation of 375 RA patients in two controlled trials. Patients treated with RAYOS ranged in age from 20 to 80 years (median age 56 years). Patients were predominantly Caucasian and 85% were female.
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