Thursday, October 15, 2009
Another Round of Trials for Vigabatrin
Firm secures funding for anti-craving tests.
A Florida pharmaceutical company has secured financing for additional testing of the anti-addiction drug vigabatrin, despite the drug’s poor performance in earlier trials. Patrick J. McEnany, chairman and CEO of Catalyst Pharmaceuticals (CPRX) in Coral Gables, said the company would continue developing CPP-109 , its version of vigabatrin, for the treatment of cocaine and methamphetamine addiction.
Vigabatrin garnered early publicity on the basis of early trials suggesting it might be effective against stimulant addiction. Unlike alcohol and heroin, cocaine and speed have proven particularly resistant to treatment with other drugs designed to diminish craving. A drug that effectively reduced craving in abstinent cocaine and methamphetamine addicts would open up a potentially large and lucrative market.
Catalyst said it raised $3.97 million in a recent common stock offering from a group of investors including Federated Kaufmann Funds. Catalyst owns exclusive licensing rights to several patents related to vigabatrin from Brookhaven National Laboratory, reports Genetic Engineering and Biotechnology News. The company also owns patents or patent applications in more than 30 countries. Catalyst recently acquired worldwide rights to a related patent held by Northwestern University.
Earlier, the U.S. Food and Drug Administration (FDA) had given Fast Track designation to vigabatrin. The drug increases brain levels of GABA, an inhibitory transmitter. However, CPP-109 failed in a mid-stage treatment for cocaine addiction. Brian Bandell of the South Florida Business Journal reported that during the 12-week study, the drug did not help addicts stay cocaine-free, compared to a placebo group. In July, the company’s stock was trading at a 52-week low of 39 cents.
Last week, Catalyst said its decision to renew testing and development efforts with vigabatrin was due to a reanalysis of data from the earlier test. The company said the review showed that overall test subject compliance rates during the clinical trial may have been as low as 40 %. The company also said that early results with methamphetamine addiction were promising, but not statistically significant due to the small number of test subjects.
Last year, there was also a flurry of interest in vigabatrin as a weight loss drug. (See my earlier post). The FDA has yet to approve the drug for use in the U.S., citing concerns about reports of retinal damage in patients overseas. Catalyst said it had not uncovered any clinically significant visual abnormalities in its CPP-109 testing programs.
Vigabatrin, or gamma vinyl-GABA, is marketed in Europe as Sabril, and has existing clinical uses for the treatment of specific types of epilepsy and infant spasms.
Graphics Credit: www.dosewatch.com