By Pat Anson, PNN Editor

Competition has grown intense between pharmaceutical companies in the $2 billion U.S. migraine market.

You’ve probably seen their TV commercials. Eli Lilly hired Olympic athletes to pitch Emgality, an injectable migraine preventative, while reality star Khloé Kardashian is appearing in commercials for Nurtec, an oral medication made by Biohaven Pharamceuticals

Lilly is now taking the competition a step further, with an unusual head-to-head clinical study – rare in the pharmaceutical industry – that pits Emgality against Nurtec. The company is enrolling 700 adults with episodic migraine in a randomized, double-blind, placebo-controlled trial. The so-called CHALLENGE-MIG study will directly compare the efficacy and safety of the two drugs.

“Lilly’s CHALLENGE-MIG study will help us understand how different types of preventive medications may help people achieve the goals that matter most to them. It’s exciting that insights generated in this first-of-its-kind head-to-head trial will be able to spark treatment plan discussions between people with migraine and their health care providers,” Shivang Joshi, MD, a trial investigator at Dent Neurologic Institute, said in a Lilly press release.

Emgality and Nurtec both inhibit calcitonin gene-related peptides (CGRP), a protein that causes migraine pain, but their delivery systems are very different. Emgality is injected once a month, while Nurtec is taken in a pill every other day.

Emgality was one of the first CGRP inhibitors to be approved by the FDA in 2018, while Nurtec is a relative newcomer, first approved in 2020. Nurtec’s label was recently expanded to include both migraine prevention and treatment.

The primary goal of the Lilly study is to see which drug gives patients a greater reduction in monthly headache days, with a secondary goal of measuring quality of life improvements.

“We believe patients should expect more and get more from medications that can help prevent migraine. Therefore, we look forward to sharing the findings from our Emgality versus Nurtec ODT head-to-head trial,” said Anne White, senior vice president of Eli Lilly and president of Lilly Neuroscience.

Biohaven’s CEO welcomes the study and sees it as an affirmation of Nurtec’s growing share of the market. Since it was introduced last year, Nurtec has generated about $200 million in revenue for Biohaven, with over 750,000 prescriptions filled. 

"This new head-to-head trial affirms that Nurtec ODT is perceived as the new standard of care.  The dual-therapy action of Nurtec ODT is unique and provides clear advantages to both treat and prevent migraine attacks.  Since the launch of oral acute CGRP agents, the performance of injectable CGRP (inhibitors) is now negligible to flat,” Vlad Coric, MD, CEO of Biohaven Pharmaceuticals, said in a statement to PNN. 

“Regardless of this Emgality study outcome, the Nurtec ODT value proposition will not be matched. And Nurtec ODT will have an impressive and entrenched market penetration by the completion of the proposed head-to-head study.  We continue to hear from patients, who want oral over needle-based therapies.” 

Regardless of whether it’s a pill or injection, both drugs are expensive. A supply of eight Nurtec tablets costs about $941, depending on insurance coverage. The listed price for Emgality is $627 for a single injection or about $7,524 annually.

If you’d like to know more about the study or possibly enroll in it, call the Lilly Answers Center at 1-800-545-5979.