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Prednisone Delayed-Release Tablets Approved for RA


July 27, 2012 — The US Food and Drug Administration has approved prednisone delayed-release tablets (Rayos, Horizon Pharma) at the 1-, 2-, and 5-mg doses for rheumatoid arthritis (RA).
The agency also approved Rayos for polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.
The approval was based on new data indicating that the pharmacokinetics of delayed-released prednisone tablets are comparable to those of immediate-release prednisone.
According to a company written release, the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials helped demonstrate the efficacy of this agent. The trials were reported on by Medscape Medical News in November 2010.
"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 company states, while the overall safety of this agent was established in the CAPRA-1 trial.
"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," said Timothy P. Walbert, chairman, president, and chief executive officer of Horizon Pharma. "Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for [prednisone delayed-release tablets] in key IL-6 mediated diseases, including asthma and COPD," he added.
According to the company, patients can take prednisone delayed-release tablets immediately prior to going to sleep. The prednisone is released over about 4 hours, which corresponds to the time many patients with rheumatoid arthritis begin experiencing discomfort and stiffness.

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