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news.FDA has granted IND exemption to permit clinical studies on this non-sedating barbiturate drug in the US
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Taro Pharmaceutical Industries (Taro) has initiated phase I clinical trials in Canada with T2007, the second in the company’s class of proprietary non-sedating barbiturate compounds to be approved for studies in humans.
T2007 is the sodium salt of diphenylbarbituric acid (DPB). Reportedly, in previous phase II studies conducted in Canada, T2000, a prodrug (precursor) of DPB, has produced functional improvement in patients with essential tremor.
The company has said that the FDA has granted an Investigational New Drug (IND) exemption to permit clinical studies on T2000 in the US. Taro expects that its experience with T2000 is likely to facilitate its development of T2007.
Taro said that the plans for T2007 are currently directed at its use as an antiepileptic agent. In animal models, DPB has efficacy comparable to phenobarbital, a long-established clinical treatment for epilepsy.