NDA For INP104 Submitted, Sodium Oxybate Improves Nocturnal RBD, Health-Deficit Accumulation Leads to Cognitive Impairment

This week Neurology News Network covered the new drug application submission for INP104, an acute migraine agent, more results on the efficacy of sodium oxybate in patients with type 1 narcolepsy, and a study that evaluated the effects of health-deficit accumulation on cognitive impairment.

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.

According to a recent announcement, Impel NeuroPharma has submitted a new drug application (NDA) to the FDA for its investigational migraine treatment, INP104. The therapy is delivered by Impel’s precision olfactory delivery (POD) platform. The NDA is supported by the phase 3, open-label STOP-301 study that included 360 patients with acute migraine, with or without aura, at 36 sites. The study included more than 5650 migraine attacks treated over the course of either 24 or 52 weeks. Over the entire 52 weeks, there were no reported drug-related serious AEs. In the Full Safety Set, 66.3% of patients achieved pain relief and 38% of patients achieved pain freedom at 2 hours following their first dose of INP104.The Primary Safety Set, which included 185 patients, showed that 33.1% of patients who took an average of 2 or more doses of INP104 per the 28-day period during the 24-week treatment phase achieved pain freedom at 2 hours. Initial onset of pain relief began as early as 15 minutes for 16.3% of patients and continued to improve over time.

Sodium oxybate, a first-line treatment of type 1 narcolepsy (NT1), has the ability to improve nocturnal rapid eye movement sleep behavior disorder (RBD) and REM sleep without atonia (RSWA) in patients with NT1, according to a newly published study.The study evaluated 19 children and adolescents with NT1 who underwent 3 months of stable treatment with SO. RSWA, automatically computed by means of the validated REM sleep atonia index (RAI) was significantly improved in patients who received the drug compared to baseline. Study author Giuseppe Plazzi, MD, director, Sleep Laboratory, Department of Neurological Sciences, University of Bologna, and colleagues noted that the treatment “remarkably” reduced complex movements during REM sleep. They wrote that the improvements on RBD and RSWA point to a direct role of the drug in modulating motor control.

Newly published data suggests health-deficit accumulation, specifically among older Americans, affects the likelihood of progressive cognitive impairment, as well as the likelihood of cognitive improvement independent of the APOE ε4 allele. Investigators calculated a frailty index score using the deficit-accumulation approach in participants aged 50 years and older from the National Alzheimer’s Coordinating Center. Among those not cognitively impaired, each 0.1 increment increase in score were associated with a higher risk of developing mild cognitive impairment and a higher risk of developing dementia. In total, there were 14,490 participants in the study with a mean age of 72.2 years. In the MCI subsample (n = 4717) at baseline, there was a higher degree of frailty that was associated with a lower probability of being reclassified as NCI from MCI, a higher risk of returning to MCI in those who were reclassified as NCI, and a higher risk of progressing to dementia.

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