NURTEC FDA Approval Supported by DelRicht Research

FDA Approves NURTEC™ ODT for the Acute Treatment of Migraine in Adults

FDA Approves NURTEC™ ODT for the Acute Treatment of Migraine in Adults

NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved NURTEC ODT (rimegepant) for the acute treatment of migraine in adults, offering a fast-acting, single-dose oral therapy in a convenient, quick-dissolve tablet. This marks the first FDA-approved product for Biohaven Pharmaceuticals and introduces a new class of CGRP receptor antagonists for migraine relief.

Dr. Patrick Dennis, Principal Investigator at Touro Medical Center in New Orleans, LA, contributed to the pivotal clinical trials leading to approval, in partnership with DelRicht Research. Dr. Dennis has led numerous clinical trials across a range of therapeutic areas with DelRicht since 2016, with a consistent focus on advancing neurologic and pain-related care.

NURTEC OCT’s Fast Relief in a Single, Dissolvable Dose

Migraine affects nearly 40 million Americans, disrupting daily life and causing significant disability. NURTEC ODT addresses an unmet need with its quick-dissolve formulation, which provides relief without water and begins working within one hour, offering up to 48 hours of sustained relief for many patients. The medication is not indicated for preventive treatment, but it gives patients a powerful new option to respond to migraine attacks as they happen.

In a pivotal Phase 3 trial, NURTEC ODT showed statistically significant improvement in pain freedom and freedom from the most bothersome symptom two hours post-dose. Benefits also included faster return to normal function and lower reliance on rescue medications. With only a 2% incidence of nausea as the most common side effect, NURTEC ODT offers a well-tolerated alternative for patients unable to use or respond to triptans.

“Helping bring fast, effective therapies like NURTEC to patients is exactly why we do this work,” said Marshall Morris, Partner at DelRicht Research. “This approval represents a meaningful advancement for the migraine community, and we’re proud of Dr. Dennis and the New Orleans team for their role in supporting this trial.”

“Helping bring fast, effective therapies like NURTEC to patients is exactly why we do this work. This approval represents a meaningful advancement for the migraine community, and we’re proud of Dr. Dennis and the New Orleans team for their role in supporting this trial.”

— Marshall Morris, Partner at DelRicht Research

Empowering Patients with a More Accessible Option

Dr. Dennis’s site was among those that contributed to Biohaven’s data on both short-term efficacy and long-term safety, which included more than 3,100 patients and over 113,000 doses administered. The trial results demonstrated not just fast relief but also a high level of patient satisfaction and minimal need for additional medications.

“For patients who’ve struggled with limited options or intolerable side effects, NURTEC offers a convenient and effective way to take back control during a migraine,” said Dr. Patrick Dennis, Principal Investigator. “We’re proud to support treatments that put patients first.”

“For patients who’ve struggled with limited options or intolerable side effects, NURTEC offers a convenient and effective way to take back control during a migraine. We’re proud to support treatments that put patients first.”

— Dr. Patrick Dennis, Principal Investigator at DelRicht Research

A New Era in Migraine Treatment

NURTEC ODT is the first FDA-approved CGRP receptor antagonist in a quick-dissolve tablet, combining speed, portability, and sustained relief in a single dose. Its approval signals the beginning of a new era in migraine care, one focused on convenience, efficacy, and patient experience.

With experienced investigators like Dr. Dennis and site partners like DelRicht Research helping to shape the future of neurological treatment, therapies like NURTEC are poised to improve the lives of millions living with migraine.

Read the full press release on Biospace.

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