Did you know the FDA has approved 27 novel drugs so far in 2019, and two of those are for narcolepsy?! How amazing is that?! The diversification of treatment approaches and new therapies under development and gaining FDA-approval for narcolepsy in the U.S. is SO EXCITING! In this post, I will provide an update on the narcolepsy drug development space and report back highlights from World Sleep 2019. This is Part II, Part I on hypocretin/orexin agonists is here.
Recent FDA Approvals:
- Background: Solriamfetol (trade name Sunosi) is a wake-promoting agent, a dual-action dopamine and nonrepinephrine reuptake inhibitor to treat excessive daytime sleepiness in people with narcolepsy and obstructive sleep apnea. Clinical and preclinical data suggested that the wake-promoting effects of solriamfetol differ from medications such as modafinil and amphetamine.
- Research Findings: Approval of Sunosi was based on data from clinical trials including:
- One study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2)
- Two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4),
- An open-label long term safety and maintenance of efficacy for the treatment of excessive sleepiness in patients with narcolepsy or OSA (TONES 5).
- FDA APPROVAL & Available Now: On March 20, 2019, Jazz Pharmaceuticals announced here that the FDA approved solriamfetol/Sunosi for the treatment of excessive sleepiness in adults with narcolepsy or obstructive sleep apnea. As of July 2019, Sunosi is now commercially available for healthcare professionals and patients in the U.S.
- Background: Pitolisant is a histamine H3 receptor inverse agonist that activates histamine neurons, which is an exciting advancement because pitolisant works via a different mechanism of action than any other treatment options currently available for narcolepsy. This article offers some neat ideas about how the treatment may work.
- Pitolisant has been on the market in Europe since 2016 when approved by the European Medicines Agency. In Europe, pitolisant is known by its trade name “Wakix”. In October 2017, Harmony Biosciences, LLC acquired the rights to develop, register and market the drug in the United States.
- Research Findings:
- Phase 3 study results focused on