The FDA has approved Biohaven Pharmaceutical Holding Co. Ltd.’s Nurtec ODT (rimegepant) for treatment of acute migraine in adults, the first calcitonin gene-related peptide (CGRP) receptor antagonist on the market as an orally disintegrating tablet.

Nurtec, New Haven, Conn.-based Biohaven’s first FDA-approved product, is the second oral small-molecule CGRP antagonist to be approved. It was narrowly beaten by Ubrelvy (ubrogepant, Allergan plc), which received FDA approval in December.

Nurtec was touted by Cortellis Drugs to Watch as one of 11 drugs that could become blockbusters, garnering annual sales of more than $1 billion, within five years. It, along with ozanimod (RPC-1063) from Bristol-Myers Squibb and Co., of Princeton, N.J., and ofatumumab (OMB-157) from Novartis AG, of Basel, Switzerland, was one of three CNS drugs to make the list.

The migraine market is massive. More than 25 million people in the U.S. get migraines and the World Health Organization labeled the indication as one of the top four neurological causes of disabling conditions. Anticipated sales could soar to $1.03 billion in 2024, according to a Cortellis analysis, although Nurtec would compete with Ubrelvy and orals from other classes, such as the 5-HT 1f agonist Reyvow (lasmiditan, Eli Lilly and Co.), approved by the FDA in October 2019.

Other competitors could include Trokendi XR (topiramate, Supernus Pharmaceuticals Inc.) and Botox (botulinum toxin type A, Allergan plc).

Biohaven management told analysts a Nurtec sales force of more than 200 representatives (but not more than 1,000) have been marshalled while the FDA made its decision. The marketing is to target Nurtec’s timing, taking effect in under an hour, a single tablet that dissolves in the mouth and provides relief for up to 48 hours. The company expects to make it available in early March.

The drug blocks CGRP receptors, thought to be the core cause of migraine. CGRP is a peptide expressed in the peripheral and the central nervous system. It’s not known if Nurtec will cross the blood-brain barrier.

The company noted Nurtec is not indicated for preventive migraine treatment, however it does have a migraine prevention clinical trial underway with topline results expected by the end of March.

In the two phase III trials that put Nurtec in place for FDA approval, patients tolerated the treatment well, with 19.2% and 19.6% vs. 14.2% and 12% for placebo becoming pain free at two hours. The next category, achieving pain freedom from the most bothersome symptom were 36.6% and 37.6% compared with 27.7% and 25.2% for placebo. The most common adverse reaction was nausea, found in 2% of patients and 0.4% of those taking placebo.

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