The U.S. Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) of Biohaven Pharmaceuticals’ BHV-0223, a sublingual (dissolved under the tongue) form of riluzole, as a treatment for amyotrophic lateral sclerosis (ALS). Biohaven has begun enrollment of ALS patients for its Phase 2/3…

Biohaven Pharmaceuticals has established an expanded access program (EAP) for patients with amyotrophic lateral sclerosis (ALS) for its investigational treatment candidate, BHV-0223, the company recently announced. The United States Food and Drug Administration regulates the expanded access program to help provide access to therapies that are currently in development and have…

A dissolving tablet version of riluzole called BHV-0223 has shown positive bioequivalence when compared to the oral form of the therapy, Rilutek, developer Biohaven Pharmaceuticals announced. The dissolving tablet, placed under the tongue, is easier to administrate to patients with amyotrophic lateral sclerosis (ALS) who have trouble swallowing. BHV-0223 also was found…

Biohaven Pharmaceutical has dosed the first amyotrophic lateral sclerosis (ALS) patient with its sublingual formulation of riluzole, BHV-0223, in a pivotal Phase 2/3 trial. The trial aims to demonstrate that BHV-0223’s effects are at least equivalent to Rilutek, an approved tablet formulation of riluzole. The trial initiation was supported by…

The U.S. Food and Drug Administration (FDA) has given the green light to Biohaven Pharmaceuticals to advance sublingual BHV-0223, which regulates glutamate communication between neurons, into clinical trials for amyotrophic lateral sclerosis (ALS) patients. The FDA’s  permission to go ahead with the study followed Biohaven’s submission of an investigational new drug…

Biohaven Pharmaceuticals is pushing hard for regulatory approval and development of its two investigational drugs for amyotrophic lateral sclerosis (ALS): BHV-0223, a sublingual form of Rilutek (riluzole), and BHV-4157, a compound that modulates the neurotransmitter glutamate. After more than 20 years, Rilutek remains the only approved treatment for people with…

Portage Biotech and Biohaven Pharmaceuticals recently announced they have received positive feedback from the U.S. Food and Drug Administration (FDA) on their Pre-Investigational New Drug Application (PIND) interaction regarding Biohaven’s investigative drug BHV-0223, intended for treatment of amyotrophic lateral sclerosis (ALS). BHV-0223 is the glutamate modulating compound riluzole, contained in the tablet…

Portage Biotech, Inc. together with privately-held Biohaven Pharmaceutical Holding Company Ltd. has just acquired global intellectual property rights to an extensive 300-product portfolio by ALS Biopharma, LLC. These prodrugs included in the line up, most of which are classified as New Molecular Entities (NMEs), were originally designed and prepared by…