BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that it is initiating a Phase 2 study of BCX4208 for the treatment of gout. The primary objective of BioCryst's Phase 2 study is to determine the effect of different doses of orally administered BCX4208 on serum uric acid levels in patients with gout. The gout trial is expected to enroll up to 120 subjects. "Over the last few decades gout has markedly increased in incidence and prevalence, both in the U.S. and elsewhere. This includes a greater number of difficult cases of chronic or frequently recurrent gout in patients who are intolerant or refractory to the currently approved uric acid lowering drugs, " stated Robert Terkeltaub, M.D., VA Rheumatology Section Chief, San Diego Professor of Medicine. "The longstanding unmet need for innovative therapies to reduce hyperuricemia is now being addressed by novel agents, among them BCX4208, that act as novel therapeutics affecting uric acid formation or elimination.
Parkinson disease progresses more slowly in patients who have higher levels of urate, a chemical that at very high level is associated with gout, scientists have found. While it's unknown whether the high levels actually somehow protect patients or simply serve as a marker of protection, the finding supports the idea that patients and doctors may one day be able to better predict the course of the illness. The study, led by scientists at Massachusetts General Hospital and the Harvard School of Public Health and including physicians at the University of Rochester Medical Center, was published online in the Archives of Neurology. The new findings are based on biological samples, primarily blood and cerebrospinal fluid, collected from people with Parkinson disease who participated in a landmark study known as DATATOP, which was conducted two decades ago.
Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to ULORIC ® (febuxostat) treatment. A subset of subjects from the CONFIRMS trial who received prior urate-lowering therapy for up to five years achieved sUA gout flares than patients who had not received prior long-term urate-lowering therapy. According to Michael Becker, M.D., professor emeritus of medicine, rheumatology section, The University of Chicago School of Medicine, gout associated with hyperuricemia is a chronic condition that requires long-term management. "One of the hallmarks of gout is the painful and disabling acute flare of arthritis that patients experience. The results of the CONFIRMS trial suggest that by achieving and maintaining sUA < 6.
New Data Presented At ACR Meeting Demonstrates Colcrys TM Colchicine, USP Significantly Reduces Pain Of Acute Gout Flare Within 24 Hours
URL Pharma, Inc., announced data from a pivotal Phase III study demonstrating that Colcrys(TM) (colchicine, USP), a low-dose colchicine, reduced the pain of gout flares within a 24-hour period as effectively as high-dose colchicine with a side effect profile statistically indistinguishable from placebo. These data and two other Colcrys studies were presented this week at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting in Philadelphia. "These studies confirm that Colcrys offers patients effective relief of gout flares with significantly reduced side effects and a greater margin of safety, " said Robert A. Terkeltaub, M.D., Section Chief, Rheumatology-Allergy, VA Medical Center San Diego, and Professor of Medicine and Rheumatology Training Program Director, University of California San Diego.
URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare. Colcrys is an oral, branded form of colchicine that has been formulated for optimal efficacy and tolerability. It is the only single-ingredient colchicine to be approved by the FDA for the prophylaxis and treatment of gout flares. Colcrys provides a formulation with the efficacy of colchicine while avoiding most of the toxicity of the unapproved products historically on the market. Colcrys is also indicated for the treatment of Familial Mediterranean Fever (FMF) in adults and children 4 years of age or older.