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Horizon Pharma Announces FDA Approval Of RAYOS® (prednisone) Delayed-Release Tablets For Rheumatoid Arthritis And Multiple Additional Indications

Results from CAPRA-2 are published in Annals of the Rheumatic Diseases. 1 

"Prednisone is a common therapy for patients with various inflammatory diseases, including RA, and the delayed-release enhancement offered with RAYOS is an important treatment advance," said Michael Schiff, M.D., Clinical Professor of Medicine at the University of Colorado School of Medicine, Rheumatology Division.  "RAYOS is engineered to benefit the underlying patterns of inflammatory diseases.  RAYOS, as studied in its clinical trials with ten p.m. dosing, reduces the overnight rise of inflammatory mediators, which results in less pain and stiffness for patients as they begin their day."

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.

Included in these safety results were data from the CAPRA-1 trial, a 12 week, double-blind, placebo-controlled study that evaluated 288 RA patients.  CAPRA-1 compared 10 p.m. administration of RAYOS with the morning administration of immediate-release prednisone at the same individual dose (average dose of 6.7 mg).  Following the 12-week CAPRA-1 study, patients were followed in a 9-month, open-label extension study, which included 249 RA patients, 219 of whom completed the extension study.  Patients received RAYOS 3 mg to 10 mg once daily at 10 p.m.; the majority (84%) received 5 mg or less. 

The clinical trial experience did not raise any safety concerns beyond those already established for immediate-release prednisone.

Results from the CAPRA-1 12-week study and the 9-month open-label extension are published in The Lancet and Annals of the Rheumatic Diseases, respectively. 2,3

About RAYOS RAYOS, known as LODOTRA ® in Europe, is a proprietary delayed-release formulation of low-dose prednisone.  The pharmacokinetic profile of RAYOS is different with an approximately four-hour lag time from that of immediate-release prednisone formulations.  In clinical trials studying use of RAYOS in RA, patients were administered RAYOS at 10 p.m. with food.  Given RAYOS delayed-release profile, this helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night.  While the pharmacokinetic profile of RAYOS differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable

RAYOS utilizes SkyePharma's proprietary Geoclock™ technology.

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