John Harsh, PhD: The Future of Oxybate Therapy for Narcolepsy, Sleep Disorders

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The next step for investigating sodium oxybate is to examine the safety and efficacy with other sleeping populations, primarily, hypersomnia.

John Harsh, PhD, is the clinical research director of Comprehensive Care for Sleep Disorders at the Colorado Sleep Institute. At SLEEP 2023 in Indianapolis, IN, he detailed the recently discovered data on sodium oxybate therapy for adults with narcolepsy.

“Any sleep clinician will say their ultimate goal is to improve normal daytime functioning,” he said in an interview with HCPLive, “and that's kind of hard to achieve.”

The efficacy and safety of once-nightly sodium oxybate, also known as ON-SXB or FT218, for treating adults with narcolepsy was featured at the conference. Harsh and his team evaluated the investigational extended-release formulation of the therapy, which successfully met its coprimary endpoints.

He explained the adverse events associated with the treatment are well-established and the team didn’t observe anything shocking as compared with the twice-nightly dose.

“With this once-a-night dosing, it was much the same,” Harsh said. “Nausea was an issue, dizziness–not with high frequency, but it was there–somnambulism, anxiety, somnolence, but no new signals with the once-a-night dosing.

The next step for investigating sodium oxybate is to examine the safety and efficacy with other sleeping populations, primarily, hypersomnia to see how the therapy works among those patients.

“There's a lot of people with sleepiness that is secondary to their primary condition,” he explained, “the neurodegenerative disorders, some cases of depression where people have sleepiness, and this is just me talking, but maybe in the pediatric population.”

While there’s no research evaluating oxybate therapy in children with sleep disruption, to Harsh’s knowledge, at the last annual SLEEP 2022 meeting, groundbreaking data were shared by Amy Licis on how sleep affects children with ADHD and Autism Spectrum Disorder (ASD).1

“Children with autism spectrum disorder can have horrendous sleep difficulties, which impacts not only their functioning but their family functioning also,” Harsh continued.

References:

  1. Grossi G. Amy Licis, MD: Biological Markers of Sleep Disruption in Children with ADHD or Autism. HCPLive. Jun 10, 2022. https://www.hcplive.com/view/amy-licis-biological-markers-sleep-disruption-children-adhd-autism
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