In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ (Rimegepant) for the acute treatment of migraines in adults. In May 2021 the FDA also approved Nurtec™ for the prevention of migraine. Nurtec™ was approved in the European Union (EU) for both prevention and acute migraine treatment in April 2022.
Nurtec™ is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting, orally disintegrating tablet (ODT). Nurtec is also the only migraine medication approved to treat and prevent migraine, all in one medication.
In this case study, we look at the drug development journey that brought Nurtec™ to its ultimate destination: the patient. We also hear how the treatment has greatly improved one patient’s quality of life.
The need for migraine drug development
A very effective migraine treatment involves inhibition of calcitonin gene-related peptide (CGRP) activity. Inhibition of CGRP decreases pain transmission, dilation of dural arteries, and blocks neurogenic inflammation, all of which contribute to migraine.
Migraine headaches are a debilitating neurological disorder affecting approximately 15% of the adult population in the US; that’s approximately 38 million adults. A migraine is a pulsating headache that can last from 4 to 72 hours. Sounds, smells, and routine physical activity are just some of the things that can trigger a migraine. Migraines rank as the third most prevalent disease worldwide and the seventh highest specific cause of disability worldwide.
How Certara’s clin pharm services helped in Nurtec™ drug development
In 2017, Biohaven needed clinical pharmacology and pharmacometrics expertise to supplement their in-house drug development team working on Nurtec™.
They called on Certara for that expertise. We began by performing a gap analysis to provide strategic direction and assess benefit/risk for the Rimegepant development program. More than 20 scientists and regulatory experts at Certara partnered with Biohaven scientists to advance NurtecTM’s path to approval.
Certara scientists provided expertise in clinical pharmacology, pharmacometrics, regulatory strategy, Physiologically Based Pharmacokinetic Model (PBPK) modeling, Medical Affairs and Scientific Communications Services and project management. These continued collaborative efforts led to FDA and EU approval of NurtecTM ODT for acute treatment and prevention of episodic migraine.
Biohaven also needed support to plan and execute their Phase 1 migraine publication plan. Certara’s Medical Affairs and Scientific Communication Services team supported this aspect of Nurtec™ development. We worked with Biohaven to build a publication plan that included recommended journals, iterative review processes, quality checks, and journal submission.
We helped to develop, publish and present high quality manuscripts, abstracts, and posters adhering to journal/target venue specifications, including Good Publication Practice (GPP 2022) and ICMJE guidelines. We provided written responses to reviewers as required and helped generate publication quality figures and graphics. As of July 2024, 9 manuscripts have been published along with 16 abstracts and posters to support this important work.
Approval of Nurtec™ by the European Medicines Agency used PBPK modeling using Simcyp that negated the need for a dedicated Phase I clinical pharmacology study. The modeling work showed that high gastric pH did not significantly affect Nurtec™ bioavailability with the ODT formulation. This modeling effort saved time and cost and helped to speed this pivotal migraine medication to patients.
“Certara’s contribution to the drug development program for Nurtec™ ODT was substantial. 他们的临床药理学代表与 Biohaven 开发团队紧密合作。Certara’s considerable expertise in clinical pharmacology and pharmacometrics and flawless execution supported Nurtec™’s clinical development team and helped to prepare the clinical pharmacology NDA components.”
– Richard Bertz, PhD, Senior Vice President, Clinical Pharmacology & Pharmacometrics at Biohaven Pharmaceuticals
The impact of drug development from a patient’s perspective
Medicine is about restoring hope, dignity, and quality of life to the patients. It is about listening to the patients’ voices, respecting their autonomy, and making sure their needs and preferences are at the heart of decision making. Each treatment carries profound significance to those who entrust their wellbeing to the healthcare system.
The impact of Nurtec™ on patient quality of life is epitomized in the story of US army veteran Gregory Peterman. In May 2024, we were delighted to welcome Greg to CERTAINTY, our inaugural client summit, where he told his story.
Greg was born at Fort Devins Massachusetts and raised by an army special forces officer. He joined the army at age 18 and spent 21 years in army special operations starting with the 1st ranger battalion. His last 14 years were spent with 5th special forces group at Fort Campbell Kentucky as a Green Beret. Greg conducted 7 combat deployments and was awarded numerous combat action awards.
Greg developed migraines as a result of his combat. He tried numerous medications but could not find relief from the pain, photophobia, and phonophobia. His migraines, which he had to ride out in a darkened closet, affected his everyday life and his ability to be a parent and husband. When his doctor suggested he try Nurtec™, Greg finally found relief. Greg was so happy with Nurtec™ that he contacted the CEO of Biohaven to thank him. As a result, Greg became the spokesperson for Nurtec™ and was able to share his inspirational message of hope with people across the country.
我们可为您提供哪些帮助？
我们将临床药理学与基于模型的药物开发相结合，帮助您做出决策并取得项目成功。The involvement of clinical pharmacology with the support of model-informed drug development (MIDD) approaches will help you to achieve this objective.
Learn more about how modeling can help you identify optimal dosing regimens for new drug candidates and gain insights into the scientific communications process for publishing drug development research in this on demand webinar.
Authors
This article was originally written in August 2020, and was updated in August 2024 for accuracy and comprehensiveness.
