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FDA clears IND application of Biohaven’s lead drug candidate BHV-0223

The US Food and Drug Administration (FDA) has completed its review of Biohaven Pharmaceutical's investigational new drug (IND) application for BHV-0223 which will see the start of initial clinical studies in humans.

Canada-based Portage Biotech holds 54% equity interest in Biohaven Pharmaceutical Holding Company.

With the completion of FDA review, Biohaven now plans to immediately proceed with a Phase I trial designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of BHV-0223 in healthy volunteers.

The company said that data from this Phase I trial will be used to design Phase III trials in subjects who suffer from treatment-resistant anxiety disorders and planned to be initiated in early 2016.

BHV-0223 is a glutamate modulating agent formulated using the Zydis orally disintegrating tablet (ODT) fast-dissolve technology under an exclusive worldwide agreement with Catalent, a provider of drug development technology.

The Zydis ODT fast-dissolve is a freeze-dried oral solid dosage form that disperses instantly in the mouth and no water is required.

BHV-0223 is also protected by methods of use intellectual property licensed from Yale University School of Medicine.

The company is developing BHV-0223 for eventual commercialization in treatment-resistant anxiety disorders, focusing initially on generalized anxiety disorder (GAD).

Biohaven chief medical officer Dr Robert Berman said: "Clearance by the FDA on the IND filing for BHV-0223 will allow us to begin testing our novel formulation of this glutamate modulating agent in humans.

"While it has been 15 years since the first reports of the rapid and profound antidepressant effects of ketamine, ketamine and agents of related mechanisms have yet to be approved for use in affective disorders.

"BHV-0223 has significant potential to deliver efficacy without the psychotomimetic effects that have been reported with ketamine."