TULSA, OK – The U.S. Food and Drug Administration (FDA) has approved VYEPTI™ (eptinezumab-jjmr), the first and only intravenous preventive treatment for migraine in adults. Developed by Lundbeck, VYEPTI offers a new option for patients suffering from episodic or chronic migraines and is administered quarterly via IV infusion. The approval is based on robust clinical evidence from the PROMISE-1 and PROMISE-2 trials, which showed sustained migraine reduction with results visible as early as day one. Rachel Hastings, Managing Partner at DelRicht Research, emphasized the significance of this milestone and recognized Dr. Melita Tate for her leadership in the pivotal clinical trial.

Dr. Melita Tate, Principal Investigator at Grassroots Healthcare in Tulsa, OK, played a key role in the pivotal clinical trials through her partnership with DelRicht Research. Dr. Tate has conducted multiple studies with DelRicht since 2019 across a range of therapeutic areas, including neurology and pain management.

Rachel Hastings on a Sustained Approach to Migraine Prevention

Migraines affect more than 39 million people in the U.S. and are one of the leading causes of disability among adults under 50. VYEPTI is a humanized monoclonal antibody that targets CGRP (calcitonin gene-related peptide), a key protein involved in migraine attacks. Unlike oral therapies or injectables, VYEPTI is delivered directly into the bloodstream, allowing for rapid onset and consistent dosing every 3 months.

In clinical studies, VYEPTI demonstrated statistically significant reductions in monthly migraine days (MMD) compared to placebo. Patients experienced meaningful improvement as early as day one post-infusion, with many achieving at least a 75% reduction in migraine frequency over the first three months. Results were sustained through the second dose at six months.

“We’re proud to support breakthrough therapies like VYEPTI that truly shift the standard of care for chronic conditions,” said Rachel Hastings, Managing Partner at DelRicht Research. “Dr. Tate and the Tulsa team’s contributions to this trial underscore the important role local investigators play in expanding access to migraine solutions.”

“We’re proud to support breakthrough therapies like VYEPTI that truly shift the standard of care for chronic conditions. Dr. Tate and the Tulsa team’s contributions to this trial underscore the important role local investigators play in expanding access to migraine solutions.”

— Rachel Hastings, Managing Partner at DelRicht Research

Community-Based Research Driving Innovation

VYEPTI’s approval highlights the power of clinical collaboration between sponsors and experienced site networks like DelRicht Research. Dr. Tate’s ongoing involvement in neurology-focused trials reflects her commitment to improving care for patients who face frequent, debilitating migraines.

“For many of my patients, migraines are more than headaches; they disrupt work, relationships, and daily life,” said Dr. Melita Tate, Principal Investigator. “Being part of the VYEPTI trial gave us a chance to explore a new, fast-acting option that may offer relief where other treatments have fallen short.”

“For many of my patients, migraines are more than headaches; they disrupt work, relationships, and daily life. Being part of the VYEPTI trial gave us a chance to explore a new, fast-acting option that may offer relief where other treatments have fallen short.”

— Dr. Melita Tate, Principal Investigator at DelRicht Research

Meeting Patients Where They Are – With Options That Work

As the first FDA-approved IV therapy for migraine prevention, VYEPTI opens the door for patients who may have struggled with adherence or efficacy using other medications. The quarterly dosing schedule offers added convenience, and the early onset of action sets it apart from other preventive options.

With experienced investigators like Dr. Tate leading the way, and DelRicht Research continuing to support therapeutic advancements, treatments like VYEPTI represent a meaningful step forward in reducing the burden of migraine for patients across the country.

Read the full press release on Biospace.