Biohaven Wins FDA Approval for NURTEC ODT

Biohaven Pharmaceutical Holding Co. received approval from the U.S. FDA for NURTEC ODT (rimegepant) for the acute treatment of migraine in adults. NURTEC ODT has been developed in partnership with Catalent using its Zydis orally disintegrating tablet (ODT) technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water. NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting ODT.

Zydis technology offers advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience. A single oral dose of NURTEC ODT 75 mg can provide pain relief within one hour, while delivering sustained efficacy that lasts up to 48 hours for many patients. NURTEC ODT is the first FDA-approved product for Biohaven, a company dedicated to advancing innovative therapies for neurological diseases.

"Since rapid onset of relief is consistently ranked among the most important attributes of acute migraine medications, along with the benefits of easier administration without water, Zydis is an ideal platform for the delivery of acute migraine treatments," commented Jonathan Arnold, President, Oral and Specialty Delivery at Catalent. He added, "We are pleased to have partnered with Biohaven on the formulation, and now commercial manufacture, of this important treatment for such a debilitating condition."

Catalent’s 250,000 sq. ft. site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces over one billion ODTs annually.

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