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New Wonder Drug

Safe and Effective

In late October of 2008, United States medical researchers told the world about a spanking new drug that mimics an enzyme that human beings lack. The enzyme clears the blood of excess uric acid, the primary cause of gout. Researchers say that they can now state with certainty that the drug is safe and effective.

Pegloticase, the new Savient Pharmaceuticals drug, assists in the removal of uric acid, preventing sharp crystals from forming around joints such as fingers and toes, and which can cause excruciating pain and disability. In a phase III trial of pegloticase, the uric acid levels of gout patients fell to optimal levels within 6 hours of receiving an intravenous infusion of the drug. Phase III is the final stage of drug testing that must be accomplished before a pharmaceutical company may request United States FDA (Food and Drug Administration) approval. Phase III trials are performed on human beings.

After Forty Years

Researchers reported at a gathering of the American College of Rheumatology in San Francisco that a single infusion of pegloticase kept uric acid levels down for a minimum of half a year in a full 40 percent of patients in the trial. Lead author of the study, rheumatologist Dr. John Sundy, of North Carolina's Duke University Medical Center stated, "There hasn't been a new drug for gout in the U.S. for over 40 years."

Sundy explained that while most gout patients do well with the standard drug for gout, known as allopurinol, there exists some 50,000 patients in the U.S. alone, who either don't respond or are intolerant to the medication. Until now, these patients had no alternative medical treatment available to them. It is this group of patients who might receive the most benefit from the development of this new therapeutic option.

In history and in literature, gout has been depicted as a disease of excess—not excess uric acid blood levels, but of too great an indulgence in food and drink. While there are some lifestyles that can be linked as factors in developing the disease, it's important to remember that heredity plays a large role in who gets gout.

Some two to three million people in the United States are afflicted with gout. "The typical patient is male, probably in his 40s or 50s, who suddenly develops searing pain in one of his big toes," Sundy said.

Most other mammals possess a gene that helps produce the enzyme known as uricase. This enzyme helps break down uric acid. Humans lack the gene that serves this purpose. When uric acid levels build up in humans, their bodies have a hard time breaking up and removing the substance.

Pegloticase has some reported side effects, including headaches, nausea, chest pain, back pain, and chills. Savient Pharmaceuticals intends to market the drug under the brand name Puricase, once it receives approval and licensing. Drug market analysts believe that some of the large drug companies, including Pfizer Inc., Johnson & Johnson, Amgen Inc., and Roche Holding AG may try to buy Savient or at least become partners in the production of Puricase.