FDA’dan yavaş salınımlı ağrı kesiciye yeşil ışık…


FDA OKs Horizon Pharma’s Time-Release Painkiller

Chicago Tribune (IL) – Jul. 27, 2012

CHICAGO, July 26, 2012–The Food and Drug Administration on Thursday gave the suburban biotech company Horizon Pharma Inc. the thumbs up on a new anti-inflammatory drug, the second the company will bring to market.

Deerfield-based Horizon won approval to sell Rayos, a delayed-release version of the corticosteroid drug prednisone, which is sold in Europe under the brand name Lodotra by Horizon’s Swiss-based partner Mundipharma.

Although Horizon sought FDA approval for rheumatoid arthritis, the FDA’s ruling allows the drug to be sold for treatment of a broad range of indications.

“This is a huge milestone for the company, with two launches in one year,” said Timothy Walbert, president and chief executive officer. “Not many big companies can get two products approved in a year.”

Rayos was designed for patients to take before they go to bed. The drug’s proprietary outer layer dissolves slowly in the digestive system, releasing the common pain-relieving steroid prednisone after four hours when patients need it most. Patients with rheumatoid arthritis often experience pain in the overnight hours and stiffness in the morning.