Eptinezumab Improves Medication Overuse Headache, Submission for GTx-104 in Subarachnoid Hemorrhage, FDA Expands Indication for Vizamyl PET Imaging

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

Newly presented findings from the RESOLUTION trial (NCT05452239) showed that treatment with 100 mg doses of eptinezumab (Vyepti; Lundbeck) led to statistically significant reductions in frequency of migraine days and monthly acute medication use in patients with chronic migraine (CM) with medication-overuse headache (MOH). MOH has been a significant clinical challenge, as it arises paradoxically from the frequent use of acute migraine or headache treatments, including triptans, NSAIDs, and opioids. RESOLUTION was a large-scale trial of 608 patients with CM and MOH who were randomly assigned to eptinezumab 100 mg or placebo, using change in monthly migraine days (MMDs) over a 4-week period as the primary end point. Prior to infusion, all participants received a Brief Educational Intervention about MOH.

According to a new announcement, Grace Therapeutics has officially submitted a new drug application (NDA) for its investigational agent GTx-104, an injectable formulation of nimodipine, as a potential treatment for patients with aneurysmal subarchnoid hemorrhage (aSAH). GTx-104, considered a more convenient treatment, is delivered via intravenous (IV) administration, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. The agent, which most notably showed promise in a phase 3 study, has potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors, according to Grace. In addition, the company believes this therapy may perform better to manage hypotension in patients with aSAH.

The FDA has approved an expanded indication on GE Healthcare’s PET imaging agent Vizamyl to include both quantification of amyloid burden for patients with suspected Alzheimer disease (AD) and use in therapy monitoring. With the expanded indication, neurologists may better assess treatment response to anti-amyloid agents, select patients for disease-modifying therapy, and rely on objective amyloid PET metrics to guide diagnosis and care. A radioactive diagnostic agent otherwise known as flutemetamol F18 injection, Vizamyl was originally approved in 2013 as a way to estimate beta-amyloid (Aß) neuritic plaque density in adult patients with cognitive impairment suspected of AD.2 In the latest update, the tracer will now be used in a variety of different clinical settings, including to help determine whether the level of amyloid plaques has been significantly reduced for anti-amyloid therapy to be stopped.

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