Lemborexant and Ozanimod Available, Migraine and Stroke During Pregnancy, NDA Accepted for Amantadine

This week Neurology News Network reviewed the announced availability of lemborexant and ozanimod, as well as a study that dives into the association of migraine and stroke in pregnant women, and the accepted new drug application of amantadine in patients with Parkinson disease.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Early this month, both Eisai, with its launch of lemborexant, and Bristol Myers Squibb, with its launch of ozanimod, announced the availability of their respective newly FDA-approved agents. Lemborexant was approved for the treatment of insomnia in adults in late December 2019. The drug, which will be available in 5- and 10-mg doses, is a small molecule orexin receptor antagonist that binds to both orexin receptor 1 and 2. The approval of lemborexant was decided based on data from 2 pivotal phase 3 studies, SUNRISE 1 and SUNRISE 2, that assessed lemborexant versus placebo for 1 and 6 months. Ozanimod, on the other hand, was given the regulatory go-ahead in late March 2020, for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.

Results from a retrospective birth cohort of 3 million singleton, live births between January 2007 to December 2012, revealed an increased risk of having a hypertensive disorder, a stroke during pregnancy, or post-partum stroke in women with migraines during pregnancy. Overall, the study found 26,440 women with a diagnosis of migraine and 843 women who suffered from stroke. More specifically, 58% of all stroke events were ischemic, 11 women had strokes during pregnancy and at delivery, and 29 women had strokes during pregnancy/delivery at the post-partum period. Study authors concluded, “Approximately one-fourth of the excess cases of maternal stroke associated with migraine were attributable to hypertensive disorders. This suggests that other pathways exist between migraine and stroke during the perinatal period, potentially through pathophysiologic changes, such as increased blood volume and cerebral circulation.”

Adamas Pharmaceuticals has announced that the FDA accepted for review the company’s supplemental new drug application for its amantadine extended-release capsules as a treatment for off episodes in patients with Parkinson disease who are receiving levodopa-based therapy. The agency has set a PDUFA action date of February 1, 2021. The agent is a weak uncompetitive antagonist of the NMDA receptor, and was originally granted the regulatory go-ahead in August 2017 as the first and only medicine indicated for the treatment of dyskinesia in those receiving levodopa-based therapy with or without concomitant dopaminergic medications. Neil McFarlane, chief executive officer of Adamas went on to say, “If approved, the indication would reflect the full spectrum of GOCOVRI’s therapeutic benefit in PD motor complications and better support physicians to identify appropriate treatments for their patients,

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