Research & Development
US FDA Accepts Biohaven's Supplemental New Drug Application of Nurtec ODT for the Preventive Treatment of Migraine
15 October 2020 - - The US Food and Drug Administration has filed and accepted for review US-based Biohaven Pharmaceutical Holding Company Ltd's (NYSE: BHVN) recently submitted supplemental New Drug Application for Nurtec ODT (rimegepant) for the preventive treatment of migraine, the company said.

The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.

Migraine is a debilitating neurological disease that affects approximately 15% of the adult population in the US, comprising nearly 40 m adults.

Migraine ranks as the third most prevalent disease worldwide, and the seventh highest specific cause of disability worldwide.

It is a disabling and recurrent disease characterized by attacks lasting 4 to 72 hours with multiple symptoms, often including: pulsating, unilateral headaches of moderate to severe pain intensity that can be associated with nausea and/or vomiting, sensitivity to light (photophobia) and sound (phonophobia), aggravated by or causing avoidance of routine physical activity, and may occur with or without aura.

Nurtec ODT 75 mg was launched in March 2020 for the acute treatment of migraine, and is the first and only CGRP receptor antagonist available in an orally disintegrating tablet designed for rapid onset of action.

Biohaven also reported positive results from its pivotal study in prevention of migraine that formed the basis of the company's sNDA filing submitted to the US FDA.

The prevention trial showed that migraine patients who received rimegepant 75 mg, administered every other day, experienced a statistically significant 4.3 day reduction from baseline in monthly migraine days.

Nurtec ODT (rimegepant) is the first and only calcitonin gene-related peptide receptor antagonist available in a quick-dissolve ODT formulation that is approved by the US Food and Drug Administration for the acute treatment of migraine in adults.

The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. Nurtec ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide.

The recommended dose of Nurtec ODT is 75 mg, taken as needed, up to once daily.

The sNDA filing was based on the outcomes of a pivotal migraine preventive treatment trial of people with migraine (Study 305) as well as the rimegepant long-term, open-label safety study (Study 201) that supported the approval of Nurtec ODT for the acute treatment of migraine.

Study 305 achieved its primary endpoint demonstrating a statistically significant reduction from baseline in monthly migraine days in people treated with rimegepant compared with placebo during the third month of treatment.

Those receiving rimegepant 75 mg every-other-day (n=348) experienced a 4.3 day reduction from baseline in monthly migraine days, compared to a 3.5 day reduction in the placebo group (n=347; p
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