Addiction drug trial halted because it works so well
Monday, June 10th 2002, 12:00 am
By: News On 6
WASHINGTON (AP) _ The clinical trial of a drug that helps people quit heroin by easing the withdrawal symptoms is being halted because the drug, BriLofex, works so well.
Since it exceeded the criteria to show it worked, it would have been unethical to subject those study participants receiving a dummy comparison drug to withdrawal, said Frank J. Vocci, director of the National Institute on Drug Abuses' treatment research and development division.
BritLofex, was as effective in reducing withdrawal symptoms as a dose of morphine, but is not addictive, Vocci said.
However, the success doesn't mean the drug will be on the market anytime soon.
Studies are still needed to determine the best dose and the minimum effective dose, Vocci said, as well as to see if it works as well in outpatient use as it did in clinics.
In addition, it must still go before the Food and Drug Administration for approval.
The end of the Phase 3 trial _ when drugs are tested for effectiveness _ was announced by Britannia Pharmaceuticals Limited in London, England, which makes BritLofex.
BritLofex has been available in the United Kingdom since 1991, where it is used for about 23,000 withdrawals a year, the manufacturer said.
The company said it is looking for an American firm to work as a partner in marketing the product, which has the chemical name Lofexidine hydrochloride.
The drug reduces such withdrawal symptoms as chills, sweating, stomach cramps, vomiting, diarrhea, muscle pain, and runny nose and eyes.
The trial that was halted began in January, 2001, and was stopped following a routine review of its results. It included studies at the UCLA Integrated Substance Abuse Program in Los Angeles, New York Psychiatric Institute and Philadelphia VA Medical Center.