August 26, 2003

FDC's Grand Venture into the Pain Segment:
FDC has made a grand foray in the nonsteroidal anti-inflammatory segment with the launch of its two new products - Cylorof and Valdez .

Cylorof contains rofecoxib, which belongs to the COX-2 selective inhibitor class of drugs while Valdez contains valdecoxib, which is a second-generation COX-2 selective inhibitor - the most advanced molecule in this class.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used class of medications for treating pain and inflammation because of their excellent analgesic and anti-inflammatory effects. However the use of conventional NSAIDs like aspirin, ibuprofen, naproxen and diclofenac is often associated with potentially life threatening gastrointestinal side effects. The adverse, as well as the therapeutic, effects of NSAIDs result from their non-selective inhibition of the cyclooxygenase (COX) enzyme that is represented by two isoforms: COX-1 and COX-2.

Selective inhibition of COX-2 results in superior GI safety along with retention of excellent efficacy seen with NSAIDs. Thus COX-2 selective inhibitors like rofecoxib and valdecoxib with their efficacy equivalent to NSAIDs but with fewer GI side effects live up to the expectation of an ideal therapy in the management of pain and inflammatory disease.

Various clinical trials have established the efficacy and superior GI safety of Cylorof (rofecoxib) in the following indications:

• Relief of rheumatoid arthritis in adults
• Relief of osteoarthritis.
• Management of acute pain in adults.
• Treatment of menstrual pain.

Valdez (valdecoxib) is the latest introduction in the COX-2 selective inhibitor class. Its highest selectivity for COX-2 enzyme makes Valdez (valdecoxib) a superior option in terms of efficacy and safety compared to conventional NSAIDs and other COX-2 selective inhibitors.

Study results suggest that Valdez (valdecoxib) is significantly less likely to cause ulcers than diclofenac and may be an option for the long-term treatment of the pain and inflammation of rheumatoid arthritis.

Valdez (valdecoxib) has faster onset of action than other agents and provides excellent results in the treatment of signs and symptoms of osteoarthritis, adult rheumatoid arthritis, primary dysmenorrhoea and surgical pain.

With their unique price advantage Cylorof and Valdez are all set to make massive inroads in the pain segment.