Rayos (Delayed-Release Prednisone) Launched in U.S.
Drug is approved for rheumatologic diseases and other indications (Dec. 3)
Rayos (prednisone delayed-release tablets, Horizon Pharma) has been launched in the U.S. for the treatment of 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 focus of the commercial launch will be on rheumatologic diseases, such as RA and PMR.
The FDA approved the new drug application (NDA) in July of this year. The agency’s decision was based on data from the Circadian Administration of Prednisone in RA (CAPRA-1 and -2) trials. The CAPRA-1 study supported the overall safety of Rayos. In the CAPRA-2 study, patients with moderate to severe RA treated with Rayos showed a significant improvement in ACR20 response criteria compared with placebo, in addition to their non-biologic disease-modifying antirheumatic drug (DMARD) therapy.
Key results from the CAPRA-2 trial included the following:
- Patients treated with Rayos showed a statistically significant improvement in ACR20 response criteria — the primary study endpoint — compared with those given placebo (47% vs. 29%, respectively; P = 0.001).
- Patients treated with Rayos showed a statistically significant improvement in ACR50 response criteria versus the placebo group (22% vs. 10%, respectively; P = 0.007) and a non-significant improvement in ACR70 criteria (7% vs. 3%; P = 0.0984).
- At 12 weeks, patients treated with Rayos experienced a median decrease in the duration of morning stiffness of 55 minutes compared with a decrease of 33 minutes in placebo-treated patients (P = 0.001).
Results from the CAPRA-2 trial were published online in Annals of the Rheumatic Diseases.
Rayos — known as Lodotra in Europe — is a delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of Rayos differs from that of immediate-release prednisone formulations, with a lag time of approximately 4 hours. In clinical trials of Rayos in patients with RA, the drug was administered at 10 p.m. with food. The drug’s delayed-release profile helps to achieve therapeutic blood levels of prednisone at a time point when cytokine levels start increasing 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.
Source: Horizon Pharma; December 3, 2012.