Orally disintegrating tablet (ODT)
Calcitonin gene-related peptide receptor antagonist
Central nervous system (CNS)
Approved in the US
NURTECTM (Rimegepant) is the only calcitonin gene-related peptide (CGRP) receptor antagonist indicated for acute treatment of migraine in adults.
Formerly known as BHV-300, NURTECTM is the first available orally disintegrating tablet (ODT) developed by Biohaven Pharmaceutical.
The company submitted two new drug applications (NDAs) to the US Food and Drug Administration (FDA) in June 2019.
FDA granted approval for NURTECTM (Rimegepant) for the treatment of migraine with or without aura in adults, in February 2020.
NURTECTM (Rimegepant) is available as a fast-acting orally disintegrating tablet (ODT) with the recommended dose of 75mg once daily. The drug will be available in the market in eight tablet packs.
Migraine causes and symptoms
Migraine is a type of headache usually moderate or severe, or a throbbing pain felt in one side of the head. It can last for several hours or days if not treated properly.
The exact cause of the condition is unknown but thought to be the result of temporary changes in brain chemicals, blood vessels, and nerves.
It is a neurological disorder associated with nausea, feeling sick or being sick and higher sensitivity towards sound or light.
Common types of migraine are migraine with aura, migraine without aura, and silent migraine.
Rimegepant mechanism of action
Rimegepant reversibly blocks the CGRP receptor and inhibits the biological activity of CGRP neuropeptide.
It is the first and only FDA-approved calcitonin gene-related peptide receptor antagonist for the treatment of migraine.
NURTECTM inhibits pain transmission, reduces the neurogenic inflammation and minimises artery dilation without active vasoconstriction.
Rimegepant targets the novel CGRP receptors, playing a significant role in in the pathophysiology of migraine, and treats the root cause of migraine with a single dose.
NURTECTM (Rimegepant) is not used for the preventive treatment of migraine.
Clinical trials on NURTEC
FDA approval of NURTECTM (Rimegepant, BHV-3000) comes from positive results of Phase III randomised, multi-centre, double-blind and placebo-controlled study (study 1).
The study enrolled 1,351 migraine patients randomised to administer 75mg of NURTEC ODT (N=669) or placebo (N=682).
Patients treated with NURTECTM ODT versus placebo demonstrated significant improvements for the co-primary endpoints of freedom from pain (21% versus 11%) and freedom from the most bothersome symptom (MBS; selected from nausea, sound sensitivity or light sensitivity; 35% versus 27%).
NURTEC ODT, when compared to placebo, also showed relief from pain (37% versus 31%) and freedom from functional disability (37% versus 31%) within 60 minutes after treatment.
Within two to 48 hours, the endpoints for those with NURTEC ODT versus placebo were freedom from pain (14% versus 5%), freedom from functional disability (26% versus 15%) and relief of pain (42% versus 25%).
The most common adverse reactions found in study 1 were severe rash (in less than 1% of patients with NURTECTM ODT), nausea (in 2% patients with NURTECTM ODT versus 0.4% patients with placebo), dyspnoea and hypersensitivity.
Marketing commentary on Biohaven Pharmaceuticals
Biohaven is a clinical-stage biopharmaceutical company with a focus on innovative and late-stage compounds targeting neurological disorders, including rare diseases. Founded in 2013, its headquarters are New Haven, Connecticut, US.
The company currently includes multiple compounds in the clinical trial programme across myeloperoxidase inhibitor, glutamate modulation, and CGRP receptor antagonist.
Pipeline candidates are Vazegepant (nasal spray), Troriluzole (capsule), BHV-5000 (capsule) and BHV-3241 (tablet).
Biohaven Pharmaceuticals integrates its R&D with intellectual property licensed from companies and institutes such as AstraZeneca, ALS Biopharma, Bristol-Myers Squibb, Catalent, Rutgers University and Yale University.