Taro Pharmaceutical Industries of Israel has obtained an Investigational New Drug exemption from the US Food and Drug Administration (FDA) for a clinical trial of its T2000 drug for the treatment of essential tremor.
Taro generally develops generic versions of existing drugs. T2000, a non-sedating barbiturate compound, is the company’s first branded drug.
Essential tremor is involuntary trembling, most often in the arms, which occurs with movements, such as holding a glass or writing.
The exemption was partly based on the results of Phase I and II clinical trials of the drug in Canada. Taro’s initial study will be 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.
Information was provided by Globes, Israel’s leading online business daily.