Biopharmaceutical company Horizon Pharma, Inc., has received the US Food and Drug Administration (FDA) approval for Rayos (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).  

The US FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials.  The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response  criteria compared to placebo.  The CAPRA-1 trial supported the overall safety of Rayos.

"We are extremely pleased the FDA has approved Rayos for a broad range of indications, including RA and polymyalgia rheumatica," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma.  "Our initial focus will be on the launch of Rayos in rheumatologic diseases such as RA and polymyalgia rheumatica in the fourth quarter of this year.  Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for Rayos in key IL-6 mediated diseases, including asthma and COPD."

The efficacy of Rayos in the treatment of RA was assessed in the CAPRA-2 trial, a double-blind, placebo-controlled, randomized, 12-week trial in patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria. Enrolled patients were not currently being treated with corticosteroids but had received non-biologic disease-modifying antirheumatic drug (DMARD) therapy for at least 6 months prior to receipt of study medication, with an incomplete response to DMARD therapy alone.  Patients were randomized in a 2:1 ratio to treatment with Rayos 5 mg (n=231) or placebo (n=119) administered at 10 p.m. in addition to their DMARD therapy.  A total of 350 patients were enrolled and ranged in age from 27 to 80 years (median age 57 years).  Patients were predominantly Caucasian and 84% were female.

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.

Outside the United States, Lodotra  is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in 16 European countries and Israel.  Horizon has granted commercialization rights for Lodotra  in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited.

Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases.