Merck says trials show Vioxx to be safe, effective
Wednesday December 9, 6:07 pm Eastern Time
By Ransdell Pierson
WHITEHOUSE STATION, N.J., Dec 9 (Reuters) - Merck & Co. (NYSE:MRK - news) on Wednesday said several clinical trials indicated its experimental drug Vioxx was about as safe to take as placebos and as effective as some current therapies now used by millions of people to treat pain and arthritis.
Merck last month sought marketing approval from the U.S. Food and Drug Administration for Vioxx, a member of a promising new class of painkillers that work by inhibiting the so-called Cox-2 enzyme linked to inflammation.
Analysts have predicted Vioxx and a related rival experimental product from Monsanto Co. (NYSE:MTC - news) called Celebrex could become multibillion-dollar blockbusters if approved by the FDA.
Dr. Edward Scolnick, Merck's head of research, disclosedresults of two six-month safety studies of Vioxx at the company's annual business briefing Wednesday attended by hundreds of Wall Street analysts.
Samuel Isaly, a drug analyst for New York research firm OrbiMed Advisors, said the Vioxx data reassured him that the product was able do what it is supposed to do -- relieve pain as well as current therapies with a marked safety advantage.
''It was a powerful presentation, showing that Vioxx is a once-a-day drug that has very favorable side effect comparisons. Vioxx looks like a big winner,'' he said.
The two drugs are designed to inhibit the Cox-2 enzyme without also inhibiting the so-called Cox-1 enzyme which protects the stomach lining.
Thousands of patients taking standard current treatments, which block both enzymes, die each year of ulcers and other gastrointestinal problems.
Monsanto filed a new drug application with the FDA for Celebrex earlier this year to treat osteoarthritis and rheumatoid arthritis and expects to receive marketing approval by early 1999.
Merck is seeking permission to use Vioxx to treat acute pain and osteoarthritis -- a painful disease caused by natural wear and tear on the joints. It is expected to seek approval later for rheumatoid
arthritis, a less common but more serious genetic autoimmune disease.M/b>
Vioxx and Celebrex will attempt to displace popular non-steroidal anti-inflammatory drugs, or NSAIDs, that include aspirin, ibuprofen, naproxen and diclofenac.
Scolnick said the studies, which evaluated 1,427 osteoarthritis patients, showed the cumulative rate
of ulcers for those taking a once-daily dose of Vioxx was similar to the rate of patients taking
placebos and significantly less than the rate of those taking ibuprofen.
Ulcers were observed by using an endoscope, a device which allows doctors to view the
esophagus, stomach and small intestine.
At the end of the first three months, 7.3 percent of patients on placebo had ulcers compared to 4.7 percent taking a 25 milligram dose of Vioxx and 8.1 percent taking a 50 mg dose of Vioxx, he said.
By contrast, about 28.5 percent of patients taking ibuprofen during the first three months had ulcers, he added.
At the end of six months, the ulcer rates for Vioxx patients were 9.7 percent for those taking the 25 mg dose and 13.5 percent for the 50 mg dose. That compared with 46.4 percent of patients taking ibuprofen, Scolnick said.
Scolnick added that Vioxx was shown in two other studies to be equally effective as prescription NSAIDs and superior to placebo in relieving dental pain and pain following orthopedic surgery.
He said a 50 mg dose of Vioxx in the dental pain study was comparable with a 400 mg dose of ibuprofen in providing relief and superior to placebo within eight hours, adding that pain relief continued for 24 hours.
In the study of post-orthopedic surgery pain, Scolnick said a single 50 mg dose of Vioxx was comparable to a 550 mg dose of naproxen and superior to placebo at eight hours, with pain relief sustained at 12 hours.
Scolnick said Vioxx in both the dental-pain and post-orthopedic surgery studies began providing pain relief about as quickly as NSAIDs, within 45 minutes.
The Merck research chief said that after one year of continuous use of Vioxx, osteoarthritis patients had equivalent pain relief as patients taking diclofenac for the same period of time.
''When you add all the data up, they show that Vioxx is equivalent in effectiveness as the leading NSAIDs and its safety for the gastrointestinal track is much better than NSAIDs,'' Scolnick told
Reuters.
He predicted Vioxx, if approved, would have a package insert label clearly indicating its safety advantages over current pain treatments -- giving the new drug a powerful marketing advantage.
biz.yahoo.com |
