Stage: Phase III, may apply for approval in early 2009.
Why It MattersOsteoarthritis is by far the most common form of arthritis, affecting nearly 21 million people in the U.S. In osteoarthritis, the cartilage covering the ends of bones in joints degenerates, causing pain and stiffness as bone rubs against bone.
Millions of people rely on nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen to treat chronic pain related to osteoarthritis and other conditions, but these are linked to gut ailments such as heartburn, ulcers and bleeding, as well as high blood pressure. In addition, one of the most popular painkillers prescribed for osteoarthritis, Vioxx, was withdrawn in 2004 after reports suggesting it doubled the risk of cardiovascular events such as heart attack or stroke. Since then, the FDA now cautions that all NSAIDs may be associated with an increased risk for cardiovascular disorders.
How It WorksNaproxcinod grafts nitric oxide onto the painkilling NSAID naproxen. Nitric oxide helps dilate blood vessels and control blood pressure. Nitroglycerin is another example of a nitric oxide donor with medicinal effects. According to NicOx chief executive officer Michele Garufi, unlike nitroglycerin, Naproxcinod leads to a sustained, gentle release of nitric oxide.
Clinical trials suggest Naproxcinod treats pain, is tolerated well by the gut, and actually improves blood pressure. As a result, the FDA declared that at this time a large study into the cardiovascular safety of Naproxcinod is unnecessary.