Planned U.S. Launch of Osteoarthritis Drug Lumiracoxib Delayed Until 2005

Novartis does not plan to launch its new osteoarthritis drug Lumiracoxib in the United States until sometime in 2005 now that federal regulators have asked the drug manufacturer for additional data on the effectiveness and safety of the drug.

Lumiracoxib is a novel COX-2 selective inhibitor.

Novartis officials said they would submit a full report from an ongoing clinical trail as well as additional data requested by the Food and Drug Administration as soon as possible.

"We will work very closely with the FDA to provide all necessary data and are committed to making this medicine available to patients," said Novartis spokesman Jorg Reinhardt.

Regulators in the United Kingdom recently approved lumiracoxib under the brand name of Prexige® for use in relieving the symptoms of osteoarthritis and providing short-term relief of acute pain associated with dysmenorrhea, dental surgery and orthopedic surgery.

Other sources: Novartis Pharmaceuticals