Sodium Oxybate Approved, ANAVEX 2-73 Shows Positive Results, Ubrogepant for Acute Migraine Care, and Stroke Risk with Migraine
Neurology News Network for the week of November 3, 2018.
PUBLISHED November 03, 2018
This week, Neurology News Network covered the FDA approval of sodium oxybate (Xyrem) oral solution to include pediatric narcolepsy patients aged 7 years and older with cataplexy or excessive daytime sleepiness, the findings from a phase 2a clinical trial of ANAVEX 2-73, an investigational therapy for Alzheimer disease, a conversation with Dr. Richard Lipton about ubrogepant, and an interview with Dr. George Koshy Vilanilam to discuss the findings of a study he conducted to assess the trends and identify the risk factors for patients with migraine of developing ischemic stroke (Transcript below).
Welcome to Neurology News Network. I’m Matt Hoffman.
And I’m Jenna Payesko. Let’s get into the news from this week.
Jazz Pharmaceuticals announced that the FDA approved its supplemental new drug application, expanding the currently approved indication for 0.5 g per mL sodium oxybate (Xyrem) oral solution to include pediatric narcolepsy patients aged 7 years and older with cataplexy or excessive daytime sleepiness.
The efficacy and safety of Xyrem for treatment of cataplexy or excessive daytime sleepiness in pediatric patients with narcolepsy were established in EXPRESS, a phase 2/3 pivotal study. In EXPRESS, participants randomized to placebo and withdrawn from the therapy experienced increased weekly cataplexy attacks in comparison to those who continued treatment.
Anavex Life Sciences announced findings from a phase 2a clinical trial of ANAVEX 2-73, an investigational therapy for Alzheimer disease and Rett syndrome, which revealed a positive effect for the patients with Alzheimer treated with the higher concentration therapy.
Presented at the 11th CTAD conference in Barcelona, Spain, the late-breaking data showed a better ADCS-ADL evaluation score and a better MMSE performance for the patients on the higher concentration compared to those on the lower concentration, through 148 weeks.
Additionally, a significant impact on the drug response levels of both the SIGMAR1 and COMT genomic biomarkers was observed. These biomarkers were identified and specified at week 57, and significance was confirmed at week 148. The therapy also displayed a consistent safety profile through this 148-week period.
Although the approval of preventive CGRP inhibitors for migraine has changed the treatment landscape, there are still a need for acute migraine care. Additionally, this need often leads to other issues, such as treatment with opioids and the development of medication overuse headache.
To get some insight into this need, Dr. Richard Lipton, the Edwin S. Lowe Chair in Neurology at the Albert Einstein College of Medicine and director of the Montefiore Headache Center spoke about the lingering challenges for migraine despite the introduction of CGRP inhibitors into the fold of treatment.
Lipton tied this assessment into the recently announced positive results from a couple of trials examining the safety of a member of another newly developed class of migraine therapies: the gepants. According to Lipton, with Allergan recently reporting these positive results for its agent, ubrogepant, the therapeutic landscape looks bright.
It has been documented that the risk of ischemic stroke is twice as high in patients with migraine with aura compared to patients without aura, however, they found that there has been a significant increasing trend in patients with migraine, irrespective of aura status, having an ischemic stroke.
Let’s take a look.
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