PARIS ¿ DrugAbuse Sciences (DAS) has embarked on Phase I clinical trials of Naltrel, its slow-release version of Naltrexone, a heroin antagonist used for treating both drug abuse and alcoholism. The FDA gave the go-ahead for clinical trials on the strength of the results of preclinical studies.
Naltrel is a ¿cage¿ formulation of Naltrexone that enables the drug to enter the organism slowly and regularly by means of a single monthly injection . DAS claims this mode of administration is more efficacious and above all more suited to patients than the current formulation of Naltrexone, which has to be taken daily and thus poses problems of observance.
The Phase I trials are being carried out in the U.S., and DAS said it has enrolled 36 healthy volunteers so far. It plans to move on to Phase II/III clinical trials next year, which will be carried out in both the U.S. and Europe. If the product lives up to expectations, the company hopes to obtain marketing approval for Naltrel in 2001. ¿ James Etheridge