The FDA has approved Biohaven Pharmaceutical Holding Co Ltd’s (NYSE: BHVN) dissolvable, Nurtec ODT (rimegepant), for preventive treatment in people who experience episodic migraines or fewer than 15 days of headaches per month.
The move makes Nurtec ODT the first oral anti-CGRP drug approved for the preventive treatment of migraine and the only migraine medication approved as a dual therapy for both acute and preventive use.
Biohaven’s 75 mg pill can be taken up to once daily to stop migraine attacks, or it can be taken every other day to help prevent pain and reduce the number of attacks per month.
A single dose of Nurtec can deliver fast pain relief that lasts up to 48 hours for many patients.
The FDA based its decision on Nurtec ODT’s Phase 3 trial results that showed the drug beat placebo and led to a 4.3-day reduction in monthly migraine days after three months of treatment.
The main side effect was nausea, which occurred in 2.7% of those in the Nurtect ODT arm versus less than 0.8% on placebo.
Price Action: BHVN shares closed at $82.54 on Thursday.
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