(RxWiki News) In a new clinical trial, Teva Pharmaceutical Industries Ltd. said its experimental oral multiple sclerosis (MS) drug laquinimod reduced relapses of the disease.
The late-stage study found that patients who took the drug were less likely to have disease "flare-ups" (relapses) than those who took a placebo.
Multiple sclerosis is a progressive autoimmune disease that affects the central nervous system (the brain and spinal cord). MS episodes result in the body's immune system attacking the protective lining around nerves known as the myelin sheath. When this inflammation occurs, a host of symptoms can appear, including loss of balance, muscle spasms, numbness or abnormal sensation in any part of the body, tremor, weakness, vision loss, urinary incontinence, dizziness and sexual disturbances.
There are four different forms of MS: relapsing/remitting (in which symptoms come and go), secondary-progressive (the gradually worsening form of the disease, which those with relapsing/remitting MS sometimes advance to), progressive-relapsing (a gradual worsening form of the disease with periods of slight recovery) and primary-progressive (a gradually worsening variation of the disease with no periods of remission).
MS usually compromises a person's ability to function as they once had before being diagnosed, but many patients with the disease live full lives with little or no permanent disability.
Some 1,106 patients were enrolled in Teva's two-year clinical trial with results that will be submitted for publication in the first half of 2011.
The U.S. Food and Drug Administration (FSA) fast-tracked laquinimod last year. Drugs designated for fast track are intended to treat serious conditions and have demonstrated ability to address previously unmet medical needs.
"If this agent continues to prove safe and effective, it would be a welcome new treatment option available to people with multiple sclerosis," said Dr. John Richert, Executive Vice President, Research and Clinical Programs of the National MS Society.
Laquinimod is an orally administered, once-daily immunomodulatory compound designed to treat the relapsing-remitting form of MS (RRMS). Makers are also looking to use the drug to treat other autoimmune diseases and disorders such as Crohn's disease, rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barré syndrome, and lupus.
Teva also manufactures Copaxone, which the company says is the most prescribed MS drug in the world.