FDA Approves Intranasal Diazepam, Rimegepant and Erenumab Effectively Treats Refractory Migraine, MS Treatments Double Since 2011

This week Neurology News Network covered the FDA approval of intranasal diazepam for seizure clusters, as well as a study on rimegepant and erenumab as treatment options for refractory migraine. Additionally, we touch the rise in prices for disease-modifying therapies for multiple sclerosis over the past decade.

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

The US FDA has approved intranasal diazepam for the treatment of acute, intermittent, stereotypic episodes of frequent seizure activity, otherwise known as seizure clusters or acute repetitive seizures. The drug, which is a schedule IV controlled substance, is the first intranasal rescue formulation approved for patients age 6 and older. Notably, the FDA has granted the drug 7 years of Orphan Drug Exclusivity. An interim analysis of data from the phase 3 open-label study showed a good safety and tolerability profile consistent with what is expected for diazepam, regardless of usage frequency.

Recently published data from 2 patients with migraine experiencing suboptimal response to medication suggests that concomitant use of rimegepant and erenumab can effectively treat refractory migraine. The work, conducted by Kathleen Mullin, medical director, clinical research, New England Institute for Clinical Research, and colleagues, is the first clinical report documenting that 2 calcitonin gene-related peptide therapies can be used this way. Additionally, Biohaven submitted a new drug application to the FDA for rimegepant in the second quarter of 2019, with a PDUFA date upcoming in the first quarter of 2020.

The findings of a report from Daniel M. Hartung, PharmD, MPH, and colleagues has revealed that the spending in the US Medicaid program on disease-modifying therapies for the treatment of multiple sclerosis (MS) more than doubled from 2011 to 2017. All told, the gross annual expenditures on DMTs increased from $453 million in 2011 to $1.32 billion in 2017. Another recent study from 2019 corroborates these data, suggesting that the price of DMTs for MS patients has persistently risen over a 10-year period, with the introduction of additional therapies failing to contain out-of-control costs. Additional research suggests that clinical and financial considerations have already blurred, given out-of-pocket costs rank higher in priority for patient decision-making around DMTs than efficacy or safety.

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