Nurtec ODT

The U.S. FDA has approved the marketing of Biohaven's CGRP receptor inhibitor Nurtec (rimegepant) orally disintegrating tablets (ODT) for the acute treatment of migraine attacks in adults. This is the first CGRP receptor small molecule antagonist available in a rapidly orally disintegrating tablet form. One ​​tablet of Nurtec ODT can return patients to normal function within 1 hour, and the effects last up to 48 hours in many patients.

NURTEC ODT is the first FDA-approved product from Biohaven, a company committed to advancing innovative treatments for neurological diseases. NURTEC ODT Fast Dissolving Tablets provide rapid pain relief and return to normal function within 1 hour, and provide sustained benefits for up to 48 hours in many patients. NURTEC ODT disperses instantly in a person's mouth with little to no water, providing migraine sufferers a convenient, discreet way to take their medication anytime, anywhere.

Biohaven CEO Vlad Coric, MD, said: "FDA approval of NURTEC ODT marks an important milestone for the migraine community and a transformative event for Biohaven. Millions of migraine sufferers are sometimes dissatisfied with their current acute treatments NURTEC ODT is an important new oral acute treatment for migraine that allows patients to quickly reduce and eliminate pain and regain their lives.

Approval date: February 27, 2020

Company: Biohaven Pharmaceuticals

NURTEC. ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use

Initial US approval: 2020

Mechanism of action

Rimegepant is a calcitonin gene-related peptide receptor antagonist.

Indications and uses

NURTEC ODT is a calcitonin gene-related peptide receptor antagonist, suitable for the acute treatment of migraine with aura in adults.

Use Limitations

NURTEC ODT is not indicated for the preventive treatment of migraine.

Dosage and Administration

• The recommended oral dose is 75 mg as needed.

• The maximum dose within 24 hours is 75 mg.

• Safety has not been established for the treatment of more than 15 migraines in 30 days.

Dosage Form and Strength

NURTEC ODT orally disintegrating tablets: 75mg.

Contraindications

Patients with a history of hypersensitivity to heptose, NURTEC ODT or any of its components.

Warnings and Precautions

Allergic Reactions: If a serious allergic reaction occurs, discontinue NURTEC ODT and initiate appropriate treatment. Severe hypersensitivity reactions, including difficulty breathing and rash, can occur several days after administration.

Adverse Reactions

Nausea was an adverse reaction in ≥1% of patients treated with NURTEC ODT.

Drug Interactions

• Strong CYP3A4 inhibitors: Avoid coadministration.

• Moderate CYP3A4 inhibitors: Avoid another dose within 48 hours of coadministration with a moderate CYP3A4 inhibitor.

• Strong and moderate CYP3A inducers Guide agents: Avoid coadministration.

• P-gp or BCRP inhibitors: Avoid coadministration

Use in certain populations

• Exposure levels are significantly higher in subjects with severe hepatic impairment (Child-Pugh). C).

Packaging Supply/Storage and Handling

Supply

NURTEC ODT 75 mg orally disintegrating tablets are white to off-white, round, with a symbol debossed, and are supplied in a carton containing a blister pack of 8 orally disintegrating tablets. Each ODT contains 75 mg of rimegepant

NDC: 72618-3000-2

Storage and Handling

Store NURTEC ODT at controlled room temperature, 20°C to 25°C (68°F to 77°F); Allowable offset range is 15°C to 30°C (59°F to 86°F) [see USP Room Temperature Control]