Potential oral drug for rheumatoid arthritis

Sep 26 2005

A potential oral drug for rheumatoid arthritis (RA) may encourage women to treat their condition earlier rather than later because it is less arduous than currently available treatments. Early treatment is important because RA most often develops between the ages of 35 and 50 and is two- to three times more prevalent in women.

In an effort provide a suitable solution, Chelsea Therapeutics, a pharmaceutical company specializing in treatment for RA and other immunological diseases is developing an oral anti-inflammatory medication and is currently conducting Phase I clinical trials in the U.K.

The potential therapy known as CH-1504, was initially developed by Dr. M. Gopal Nair, a professor and vice-chairman at the department of Biochemistry and Molecular Biology at the University of South Alabama. Dr. Nair's extensive 25-years of research and published results indicate that CH-1504 may have a much better safety profile because it is not metabolized nor is toxic to the kidney and liver -- such as in the case methotrexate, the most widely prescribed RA treatment.

Because RA affects women in the prime of their lives, RA may become a nightmare-come-true for many women because most often the harsh side effects of existing therapies may out weigh the benefits, thus delaying medical attention until symptoms are much worse.

"While many people initially experience relief by using one or a combination of these therapies, in some instances, the medications may stop working over time. Raising the dose poses considerable risk for the patient," says Dr. Simon Pedder, CEO of Chelsea Therapeutics.

RA attacks cells in the joint capsules, leading to pain, stiffness and swelling of joints in the hands, arms, legs and neck limiting motion and functionality. It is a difficult disease to diagnose since its cause is unknown and symptoms fluctuate.

An early RA diagnosis and aggressive treatment is important because bone damage happens as early as the first year following onset of the disease. If left untreated, the condition destroys joints -- eventually causing permanent disability.

Current treatment options for RA include over-the-counter oral nonsteroidal anti-inflammatory drugs (NSAIDs) and other pain relievers; oral steroids; but the gold standard for treatment is still methotrexate, a drug that been used for nearly 30 years. Newly available compounds known as biologic response modifiers, such as etanercept and infliximab are used when the disease progresses (mostly in combination with methotrexate) but have to be injected and are very expensive.

While methotrexate is often effective, long-term chronic doses of the drug can be toxic to the liver, kidneys and other organs. Short-term tolerability issues such as nausea, vomiting and diarrhea also often limit its use.

"Given the problems that many patients have tolerating methotrexate along with its long-term safety concerns, a drug candidate that is proven to be as effective or more effective than with fewer side effects would be a major breakthrough in the treatment of RA. This may prompt patients to treat their condition earlier and continue treatment longer," says Dr. Pedder.

According to Dr. Pedder, with rheumatoid arthritis plaguing millions of American women, the hope is that drug candidates such as CH-1504 can help younger women comply with early treatment for RA and significantly improve their outlook in managing their condition even into their later years.