To: Anthony Wong who wrote (1043 ) 11/13/1998 12:11:00 PM From: Anthony Wong Respond to of 1722
ACR MEETING: Celebrex Relieves Arthritis Pain As Well As NSAIDs SAN DIEGO, CA -- Nov. 13, 1998 -- Results from Phase III studies of Searle and Pfizer's investigational drug Celebrex™ (celecoxib) show that the drug relieved the signs and symptoms of arthritis as effectively as the full therapeutic dose of two of the most widely-prescribed non-steroidal anti-inflammatory (NSAID) pain relievers, but with a gastrointestinal (GI) safety profile similar to placebo. The results were presented at the American College of Rheumatology's 62nd national scientific meeting. Celebrex is currently undergoing priority review by the United States Food and Drug Administration for the treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) and for the management of pain. In one of the largest clinical development programs in arthritis, celecoxib was tested in more than 14,000 patients and subjects world-wide. Celebrex is a member of a proposed new class of agents known as specific COX-2 inhibitors, which are designed to block the COX-2 enzyme activated in inflammation while sparing the activity of the COX-1 enzyme that protects the lining of the GI tract. The COX-1 enzyme also plays a role in blood clotting and kidney functions. Common side effects of NSAIDs, which are non-specific inhibitors of COX-1 and COX-2, include GI ulceration and bleeding, inhibition of platelet aggregation and interactions with other drugs. In clinical studies, celecoxib was as effective as the widely-used NSAID naproxen in both RA and OA, but with a superior GI safety profile. One of the Phase III studies, a 12-week trial involving 1,149 RA patients in an active disease (flared) state, showed that celecoxib (100 mg, 200 mg, 400 mg BID) was as effective as naproxen (500 mg BID) in relieving joint tenderness, pain and swelling and was superior to placebo. In addition, the upper GI safety profile of celecoxib was not significantly different than placebo and was superior to naproxen. Another 12-week study involving 1,004 patients with OA showed that celecoxib (100 mg or 200 mg BID) worked as well as naproxen (500 mg BID) in relieving OA symptoms and better than placebo. In a different trial, celecoxib at 600 mg BID had no effect on platelet aggregation while naproxen at a full therapeutic dose (500 mg BID) reduced platelet aggregation by 95 percent. In another study, celecoxib worked as well as the widely-used NSAID diclofenac, but with significantly fewer GI complaints and a four-fold reduction in ulcers as detected by endoscopy. This 24-week double blind study involving more than 600 RA patients demonstrated that, over the course of therapy, celecoxib (200 mg BID) was as effective in the treatment of pain and swelling of RA as diclofenac SR (75 mg BID). Post-study endoscopic exams found the incidence of gastroduodenal ulcers was nearly four times lower in celecoxib patients than those treated with diclofenac. The overall incidences of GI complaints (for example, diarrhea, abdominal pain, dyspepsia) were 33 percent higher in the diclofenac group than in the celecoxib group. In addition, more patients were able to continue taking celecoxib than diclofenac. This was due to a higher number of withdrawals based on adverse GI events in the diclofenac group. The Phase III study findings also showed that celecoxib showed no significant drug interaction when taken with methotrexate or warfarin -- two drugs often prescribed to arthritis patients.