AHS Statement on CGRP Inhibitors, NDA Submitted for Lemborexant, Dabigatran Assessed in Alzheimer


Neurology News Network for the week of January 19, 2019.

This week, Neurology News Network covered the American Headache Society's consensus statement on introducing calcitonin gene-related peptide (CGRP) inhibitors into clinical practice, Eisai submitting a New Drug Application (NDA) for its investigational insomnia treatment, lemborexant, and the news that a team from the University of Rhode Island will be conducting a proof-of-concept trial with dabigatran to assess its effect on patients with Alzheimer disease. Additionally, the network included a conversation with Paula E. Voinescu, MD, about her research into epilepsy's impact on pregnant and postpartum women. (Transcript below.)


Welcome to Neurology News Network. I’m Jenna Payesko.


And I’m Matt Hoffman. Let’s get into the news from this week.

The American Headache Society released its position on the integration of the newly approved preventive migraine therapies into clinical practice, with the goal of providing guidance to the health care professionals who will encounter them.

The guidance laid out a set of 5 circumstances which must be met in order to use the CGRP monoclonal antibodies, which included that it is prescribed by a licensed medical provider to a patient who is at least 18 years of age with a diagnosis of migraine with or without aura according to the ICHD-3. As well, the patient must have failed 6 weeks of at least 2 therapies and has at least moderate disability, as defined by a MIDA score of greater than 11 or a HIT-6 score of greater than 50.


Eisai has announced the submission of an NDA to the FDA for lemborexant for the treatment of insomnia.

The NDA is backed by results of 2 phase 3 clinical trials, SUNRISE 1 and SUNRISE 2, which enrolled roughly 2000 participants, in addition to important safety studies, such as the assessment of postural stability after awakening in the middle of the night and a next-morning driving study. The full data from the 12-month SUNRISE 2 trial will be presented at upcoming medical meetings this year.


A research team at the University of Rhode Island will be undertaking a phase 1 clinical trial evaluating the effects of dabigatran—known commercially as Pradaxa—on the vascular system’s role in Alzheimer disease.

Dabigatran, a direct thrombin inhibitor, is currently indicated for the reduction of the risk of stroke and systemic embolism in patients with non-vascular AFib, and the treatment and prevention of deep venous thrombosis and pulmonary embolism. Results of the trial are anticipated to read out in late 2020.


In a conversation with NeurologyLive, Dr. Paula E. Voinescu, an attending neurologist at Brigham and Women's Hospital, spoke about how seizure frequency during pregnancy and postpartum varies by epilepsy type. She shared some insight gained from a study of seizure frequency in pregnancy and postpartum.

Let’s take a look.

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.

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