Horizon Pharma RAYOS (prednisone) delayed-release tablets have received the US Food and Drug Administration (FDA) approval.
The approved drug is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD) .
Horizon Pharma chairman, president and CEO Timothy Walbert said the company will focus on the launch of RAYOS in rheumatologic diseases such as RA and polymyalgia rheumatica in the fourth quarter of 2012.
"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," Walbert added.
The FDA approval was based on the study bridging the pharmacokinetics of RAYOS to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials.
University of Colorado School of Medicine Rheumatology division clinical professor of medicine Michael Schiff said 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.
"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," Schiff added.
RAYOS utilizes SkyePharma's proprietary Geoclock technology and is known as LODOTRA in Europe.
