Merck & Co. will seek U.S. Food and Drug Administration approval for a narrower use of painkiller Arcoxia than it had previously sought, the drug maker said.
FDA approval of Arcoxia has been delayed for several years in the wake of safety concerns about the class of drugs to which it belongs, known as selective Cox-2 inhibitors. Arcoxia, which is approved for sale in 62 other countries, is Merck's follow-up to Vioxx, the Cox-2 inhibitor it pulled from the market in 2004, after a study showed it elevated heart-attack risk.
Merck, of Whitehouse Station, N.J., plans for now to seek FDA approval of two dose levels of Arcoxia to treat symptoms of osteoarthritis. Previously, it had sought a range of other uses, including treatment of rheumatoid arthritis and other conditions. The company said it would continue efforts to seek FDA approval for other doses and uses of Arcoxia.
Merck said Friday that it submitted a formal response to previous FDA communications about Arcoxia, which is expected to set in motion an FDA review lasting until April 2007.
Merck first applied for FDA approval of Arcoxia in 2001, submitting data from studies for uses such as relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis, and management of acute and chronic pain. The company later withdrew its original application, because it wanted to resubmit one that sought an additional use -- treating a spinal disorder known as ankylosing spondylitis -- which it did in 2003.
In October 2004, just weeks after Merck withdrew Vioxx from the market, the FDA issued an "approvable letter," saying it needed additional safety and efficacy data before it could approve Arcoxia.
That additional safety data include a group of studies known as the Multinational Etoricoxib and Diclofenac Arthritis Long-Term program, or Medal. In August, Merck said preliminary Medal data showed that the rate of confirmed thrombotic cardiovascular events such as heart attack was similar between Arcoxia and diclofenac, an older painkiller sold as Voltaren by Novartis AG of Switzerland.
But the preliminary data also showed that people on Arcoxia discontinued the drug as a result of the side effect of high blood pressure at a greater rate than those on diclofenac.
Heart specialists and other experts have criticized the design of the Medal studies, because diclofenac itself has been linked to a higher risk for cardiovascular events than some other painkillers.
Merck has insisted the comparison to diclofenac was appropriate, because it is a widely used treatment.
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