FDA Expands Approval of Oral Agent for Migraine | Stem Cell, PRP, Acupuncture in Queens & Long Island, New York

FDA Expands Approval of Oral Agent for Migraine
FDA Expands Approval of Oral Agent for Migraine


Atogepant is added to the growing class of CGRP receptor antagonists to prevent episodic and chronic migraine in adults.

People living with chronic migraine have a new oral option in the form of atogepant tablets. The FDA has approved an expanded indication of atogepant (Qulipta) to include the prevention of chronic migraine in adults, according to a statement from manufacturer AbbVie.

Atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is the first drug of its kind to receive approval for both episodic and chronic migraine, according to the company. CGRP inhibitors work to prevent migraine by blocking the action of CGRP, which is involved in pain transmission.

Chronic migraine is defined as experiencing headaches at least 15 days a month, with at least 8 headache days associated with migraine. Atogepant was previously FDA-approved for the treatment of episodic migraine in September 2021. Atogepant is available in 10 mg, 30 mg, and 60 mg doses; FDA has indicated the single 60 mg dose for chronic migraine.

The FDA approval offers patients with chronic migraine “a new, safe and effective treatment option in a convenient, once-daily pill,” said Peter McAllister, MD, director of the New England Center for Neurology and Headache, in the company statement. He added that evidence of improved function and sustained efficacy are important considerations for neurologists and headache specialists who prescribe treatments for patients with chronic migraines.

The expanded approval of atogepant was based on data from a Phase 3 study known as the PROGRESS trial. In that study, 778 individuals with chronic migraine were randomized to 60 mg of atogepant in pill form once daily, 30 mg twice daily, or a placebo for 12 weeks. The primary outcome was a reduction in the mean monthly migraine days. The study population included adults with at least a 1-year history of chronic migraine and a mean of 19 days of headache per month at baseline.

At 12 weeks, those in the atogepant group showed a significant reduction in the mean monthly migraine days from baseline compared to placebo patients. The mean change in migraine days from baseline was -7.13 in the twice-daily atogepant group, -7.27 in the once-daily group, and -4.13 in the placebo group. Individuals who took atogepant also experienced significant improvements after 12 weeks in measures of function and physical activity based on the Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities and Physical Impairment domain scores, according to the manufacturer statement.

Additionally, participants in the atogepant groups reported significant improvement in quality of life from baseline, as measured by the Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score after 12 weeks of treatment.

Safety Information

Atogepant is contraindicated for individuals who have kidney problems, liver problems, or who are on dialysis, as well as those who are planning to become pregnant or those who are pregnant or breastfeeding, according to the manufacturer. The drug also is contraindicated for those with a hypersensitivity to atogepant or any components of the medication; some patients have reported hypersensitivity reactions of anaphylaxis and shortness of breath.

The most frequently reported side effects in the clinical trial were nausea, constipation, and fatigue/sleepiness.

Other CGRP Receptor Antagonists on the Market

Additionally approved oral CGRP receptor antagonists (gepants) for migraine include ubrogepant (Ubrelvy) and rimegepant (Nurtec ODT)

Other large-molecule, injectable CGRP monoclonal antibodies include erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab-jjmr (Vyepti).

Precision Pain Care and Rehabilitation has two convenient locations in Richmond Hill – Queens and New Hyde Park – Long Island. Call the Queens office at (718) 215-1888, or (516) 419-4480 for the Long Island office, to arrange an appointment with our Interventional Pain Management Specialist, Dr. Jeffrey Chacko.

Love this Post? Spread the World

A Trusted Name for Pain Management Treatment Using Today’s Most Advanced Medical Treatments Including No Medication and No Surgery.