A small molecule CGRP receptor antagonist for migraine prevention is expected to be approved next year
Release time:
2020-10-15
Biohaven Pharmaceutical announced today that the U.S. FDA has accepted the company's recently submitted Supplemental New Drug Application (sNDA) for the preventive treatment of migraine for Nurtec ODT (rimegepant), with a response expected in the second quarter of next year. Nurtec is a small molecule CGRP receptor inhibitor. According to the press release, Nurtec is expected to be a unique treatment that can be used for both preventive treatment and acute migraine treatment.
Migraine is a debilitating neurological disorder that is the third most common disease worldwide and the seventh leading cause of disability worldwide. It is a disabling and recurrent disease that can last up to 4 to 72 hours and is accompanied by a variety of symptoms, including: throbbing, unilateral headache of moderate to severe pain intensity, which may be accompanied by nausea and/or vomiting, photophobia, and photophobia.
Nurtec ODT is the first CGRP receptor antagonist with a rapidly dissolving dosage form, and it has been approved by the US FDA for the acute treatment of adult migraine. The activity of neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraine. Nurtec inhibits the bioactivity of CGRP neuropeptides by reversibly blocking CGRP receptors.
The sNDA application is based on the results of a pivotal migraine prevention treatment trial in patients with migraine (Study 305) and a long-term, open-label safety study supporting approval of Nurtec for the acute treatment of migraine (Study 201).
Study 305 met its primary endpoint, and at 3 months of treatment, the Nurtec group had a statistically significant reduction in migraine days per month from baseline compared to placebo, with patients (n=348) having 4.3 fewer migraine days per month from baseline compared to the placebo group (n=347; p<0.05). Importantly, 49.1% of patients in the Nurtec group had at least a 50% reduction in the average number of days of moderate to severe migraine per month from baseline, compared with 41.5% in the placebo group (p<0.05).
Migraine is a debilitating neurological disorder that is the third most common disease worldwide and the seventh leading cause of disability worldwide. It is a disabling and recurrent disease that can last up to 4 to 72 hours and is accompanied by a variety of symptoms, including: throbbing, unilateral headache of moderate to severe pain intensity, which may be accompanied by nausea and/or vomiting, photophobia, and photophobia.
Nurtec ODT is the first CGRP receptor antagonist with a rapidly dissolving dosage form, and it has been approved by the US FDA for the acute treatment of adult migraine. The activity of neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraine. Nurtec inhibits the bioactivity of CGRP neuropeptides by reversibly blocking CGRP receptors.
The sNDA application is based on the results of a pivotal migraine prevention treatment trial in patients with migraine (Study 305) and a long-term, open-label safety study supporting approval of Nurtec for the acute treatment of migraine (Study 201).
Study 305 met its primary endpoint, and at 3 months of treatment, the Nurtec group had a statistically significant reduction in migraine days per month from baseline compared to placebo, with patients (n=348) having 4.3 fewer migraine days per month from baseline compared to the placebo group (n=347; p<0.05). Importantly, 49.1% of patients in the Nurtec group had at least a 50% reduction in the average number of days of moderate to severe migraine per month from baseline, compared with 41.5% in the placebo group (p<0.05).
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图片ALT信息： Ruichen Kangda Biopharmaceutical (Wuhan) Co., Ltd.
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