Lumiracoxib (Prexige)
Lumiracoxib is a COX-2 inhibiting drug designed as a pain relief medication. This drug was developed by Novartis, a Swiss drug company, and is marketed under the brand name Prexige.
Prexige was approved for clinical use in the United Kingdom in September of 2003. Novartis submitted lumiracoxib for approval by the United States Food and Drug Administration. In September 2003, the FDA requested a final report of the TARGET study as well as additional clinical data before considering final approval of the Prexige for clinical use.
The TARGET study (Therapeutic Arthritis Research and Gastrointestinal Events Trial) was initiated by Novartis as a means to establish the efficacy of lumiracoxib for reducing pain while limiting gastrointestinal side effects. In response to criticisms of the clinical data of the initial TARGET study in August 2001, Novartis initiated an additional 18,000-patient study to directly ascertain the impact of Prexige on the cardiovascular system. This study should be able to determine if Prexige causes the same type of heart attack, stroke and blood clot side effects as Vioxx (rofecoxib).
The FDA request for additional information caused Novartis to delay the U.S. launch of the drug until 2005. In addition to the United Kingdom, lumiracoxib is approved for sale in 16 other countries including Australia and several Latin American countries such as Brazil, Mexico and Argentina.
Like other COX-2 drugs, lumiracoxib was developed to target the inhibition of the COX enzymes inducing pain and swelling. In order to reduce stomach irritation, bleeding ulcers and other intestinal side effects of traditional pain relief medications, Bextra was designed to selectively inhibit the COX-2 enzyme and leave, as much as possible, the COX-1 enzyme unaffected. COX-1 enzymes are known to be important for the maintenance of stomach lining and other mucus membranes in the intestine.
Lumiracoxib is considered to be the most potent of the COX-2 drugs in terms of COX-1 versus COX-2 selectivity. The selectivity ratio is the highest for any of the COX inhibiting drugs, at 400. However, lumiracoxib has a unique chemical make-up that hypothetically allows it to focus on inflammatory sites within the body, and not have the cardiovascular side effects similar to the other COX-2 inhibiting drugs. This hypothesis is yet to be proven.