FDA to Review Intranasal Zavegepant for Migraine Treatment
The NDA submission includes data from 2 pivotal studies that evaluated zavegepant in adults with at least a 1-year history of migraine and migraine attacks.
The NDA submission includes data from 2 pivotal studies that evaluated zavegepant in adults with at least a 1-year history of migraine and migraine attacks.
The PROGRESS study compared the efficacy and safety of atogepant to placebo in 778 adults with at least a 1-year history of chronic migraine.
Lauren R. Natbony, MD, takes us on a deep dive into the association between nutrition and dietary patterns in migraine, including proposed mechanisms, and the remaining needs in patient education and research.
The HER-MES trial included 777 adults with episodic or chronic migraine (at least 4 migraine days/month) who were treatment-naïve, not suitable for, or had previously failed up to 3 prophylactic migraine treatments.
An expert roundtable of headache specialists helps outline chronic migraine as its own entity, disparities and barriers to treatment, and a need for better research and education.
The analysis included 64 randomized clinical trials with a total of 46,442 patients.
Trudhesa uses proprietary technology to deliver a lower dose (0.725mg per spray) of dihydroergotamine mesylate to the upper nasal space.
The application is supported by data from the phase 3 MOMENTUM and INTERCEPT trials.
The approval is supported by data from the phase 3 STOP 301 study, which evaluated the safety and tolerability of Trudhesa in 354 adults with migraine.
Nerivio is a wireless remote electrical neuromodulation device approved for the acute treatment of episodic or chronic migraine in patients 12 years of age and older.