FDA Approved Drugs » 2012
Medical Areas: Immunology | Musculoskeletal | Pulmonary/Respiratory Diseases | Rheumatology | Family Medicine | Orthopedics/Orthopedic Surgery
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Horizon Pharma
Approval Status: Approved July of 2012
Treatment Area: certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions
Rayos is an orally active modified-release formulation of prednisone, a corticosteroid. Corticosteroids are primarily used for their potent anti-inflammatory effects in disorders of many organ systems and they modify the body’s immune responses to diverse stimuli.
Rayos is specifically indicated for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation.
Rayos is supplied as a delayed release tablet for oral administration. The dose of Rayos should be individualized according to the severity of the disease and the response of the patient. The initial dosage of Rayos may vary from 5 to 60 mg per day depending on the specific disease. Rayos should be taken daily with food.
FDA ApprovalThe FDA approval of Rayos was based in part on one multicenter, double-blind, placebo-controlled, randomized, 12-week trial in patients with rheumatoid arthritis. This trial enrolled 350 adults not currently treated with corticosteroids but had received non-biologic DMARD therapy for at least 6 months and had an incomplete response to DMARD therapy alone. The subjects were randomized to Rayos 5 mg or placebo administered at 10 pm. The primary endpoint was the percentage of subjects with improvement in rheumatoid arthritis at 12 weeks using ACR response criteria (ACR20). In the Rayos arm, 47% of subjects reached ACR20 versus 29% in the placebo arm. In addition, subjects treated with Rayos had a median decrease in the duration of morning stiffness of 55 minutes compared to 33 minutes in the placebo arm.
Adverse events associated with the use of Rayos may include, but are not limited to, the following:
Rayos is an orally active modified-release formulation of prednisone, a corticosteroid. Corticosteroids are primarily used for their potent anti-inflammatory effects in disorders of many organ systems and they modify the body’s immune responses to diverse stimuli. The pharmacological effects of prednisone which are due to its corticosteroid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion.
Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, Jeka S, Krueger K, Szechinski J, Alten R Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial. Lancet 2008 Jan 19;371(9608):205-14
For additional information regarding Rayos or inflammatory disorders, please visit the Rayosrx web page.