CBD Under FDA Review, Rimegepant Meets Endpoint, Sleep-Disordered Breathing Associated With Alzheimer Disease

This week's Neurology News Network details the FDA review of CBD for tuberous sclerosis complex, as well as the newly FDA approved rimegepant and a study assessing sleep-disordered breathing with risks of Alzheimer disease.

Marco Meglio: 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.

Cannabidiol is officially under review by the FDA for the treatment of seizures associated with tuberous sclerosis complex, according to an announcement from GW Pharmaceuticals. The drug, marketed as Epidiolex, has received priority review and has been assigned a PDUFA date of July 31, 2020. Epidiolex was previously approved in June 2018 for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients age 2 and older. The phase 3 trial included 224 patients, 75 of whom were randomly assigned to receive 25 mg CBD, 73 who recieved 50 mg CBD, and 76 to placebo. Median baseline monthly TSC-associated seizure frequency was between 54 and 61 across the 3 groups. Additionally, compared with placebo, 36% of patients in the 25 mg group and 40% in the 50 mg group experienced a ≥50% reduction in seizures.

Biohaven has announced that its FDA-approved migraine treatment, rimegepant, met its primary end point in the preventive treatment of migraine in both episodic and chronic migraine patients. Patients who received oral rimegepant 75 mg every other day experienced a statistically significant 4.5-day reduction from baseline in monthly migraine days, compared to a 3.7-day reduction in placebo group. Additionally, researchers noted at least a 50% reduction from baseline in mean number of moderate to severe migraine days per month in 48% of the rimegepant group. Biohaven plans to engage the FDA and European Medicines Agency to submit a sNDA and an MAA, respectively, for rimegepant for the indication of preventive treatment of migraine.

New study results on the brain changes associated with sleep-disordered breathing in older adults without cognitive impairment suggest that screening for and treating SDB in older adults—particularly those who are asymptomatic—may be able to reduce the risk of Alzheimer disease. Amyloid burden was notably greater in those with SDB than those without, as well as gray matter volume. In addition to those, perfusion and metabolism were greater and overlapped primarily over the posterior cingulate cortex and precuneus. Investigators wrote, “We believe that these overlapping patterns reinforce the likelihood of common underlying mechanisms. Indeed, it has been demonstrated that higher neuronal activity is associated with increased β-amyloid production.”

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