Taro Pharmaceutical Industries Ltd. (“Taro,” the “Company,” Pink Sheets: TAROF) announced that it has been granted an Investigational New Drug (“IND”) exemption by the United States Food and Drug Administration, (“FDA”), to permit clinical studies on T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid), one of a class of non-sedating barbiturate compounds currently in development by the Company. The approval of the IND followed FDA review of all relevant preclinical data generated by the Company, as well as the results of Phase I and Phase II trials conducted in Canada. To date, a total of 199 subjects have received T2000, including 9 patients who have been treated for periods of 3 to 18 months.
The initial study approved by the FDA under this IND is a drug interaction study to assess the safety and tolerability of T2000 and the beta-blocking drug, propranolol, when taken together in healthy human subjects. In previous Phase II studies, T2000 produced a functional improvement in patients with essential tremor. Since many patients with essential tremor obtain some limited benefit from propranolol, it is important to establish the safety of the administration of these two drugs together prior to beginning more definitive Phase III studies.
Taro Pharmaceutical Industries Ltd.