LAKE FOREST, Ill., Dec. 15 /PRNewswire-FirstCall/ -- TAP Pharmaceutical Products Inc. announced today that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for febuxostat 80 mg and 120 mg for the management of hyperuricemia in patients with chronic gout.
Hyperuricemia, elevated uric acid levels in the body, is associated with gout, a painful type of arthritis. Febuxostat, an oral, once-daily medication, is a novel non-purine, selective inhibitor of xanthine oxidase (NP-SIXO) studied for its effects on lowering levels of serum uric acid (sUA) in patients with gout. TAP licensed febuxostat from Teijin Pharma Limited, based in Tokyo, Japan.
"It's been almost 40 years since a new oral treatment for chronic gout has been approved in the United States, so we're pleased to be filing an NDA for a compound that could present these patients with a new option," said Alan MacKenzie, president of TAP. "Additionally, this filing represents an important milestone toward our commitment to rheumatology."
The NDA submission includes one of the largest Phase III studies of chronic gout patients in the United States to date. This randomized, controlled, 52-week study involved 760 patients with diagnosed gout and sUA level greater than or equal to 8.0 mg/dL. Febuxostat 80 mg daily (53 percent, n=255) and 120 mg daily (62 percent, n=250) reached the study's primary endpoint of lowering sUA levels to below 6 mg/dL for three consecutive months, compared to treatment with allopurinol 300 mg daily (21 percent, n=251), the most commonly used treatment in chronic gout. Experts recognize that the standard goal in the treatment of chronic gout is the reduction and maintenance of sUA levels of less than 6 mg/dL.
"In addition to treating acute attacks of arthritis, the management of chronic gout includes control of the serum urate level. In the clinical studies, more patients taking febuxostat than allopurinol achieved the target level of less than 6.0 mg/dL," said Michael A. Becker, M.D., professor of medicine, University of Chicago.
The overall incidence of adverse reactions in clinical studies was similar among treatment groups. The most commonly reported adverse reactions were: liver function test abnormalities, diarrhea, headache and nausea. Adverse events among trial participants were generally self-limiting and mild to moderate in severity.
Uric Acid and Gout
Gout is the most common inflammatory arthritis in men older than 40 years. According to the National Health and Nutrition Examination Survey III 1988- 1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition characterized by attacks, or "flares," marked by intense pain, redness, inflammation, and warmth in the affected joint. These attacks often occur at night, waking the patient from sleep. Typically, symptoms begin in the big toe but may involve other joints. These symptoms are the result of an acute inflammatory response to the presence of crystallized uric acid in the joint(s). As the disease progresses, these attacks may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi, that can eventually lead to joint deformity.
Uric acid is a by-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when this process results in elevated uric acid levels, either through overproduction or underexcretion of uric acid or a combination of the two. Hyperuricemia is a precursor to gout; the higher a person's urate level, the greater the risk for developing gout.
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott, headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited, of Osaka, Japan. TAP markets Prevacid(R) (lansoprazole) and Lupron Depot(R) (leuprolide acetate for depot suspension). For more information about TAP Pharmaceutical Products Inc., and its products, visit the company's Web site at http://www.tap.com/ .
TAP Pharmaceutical Products Inc.