Geert Mayer, MD

“I think it [solriamfetol] does a great reduction and the number of patients who are responders is extremely high."

Over the years, sleep medicine has undergone a great deal of advancement in therapeutics, but one disorder particularly lacking good, safe and effective treatments is excessive sleepiness with narcolepsy or obstructive sleep apnea. Solriamfetol, a dopamine and norepinephrine reuptake inhibitor with wake-promoting effects, is one such entity under investigation. In March, the FDA accepted an application for solriamfetol as a treatment for excessive sleepiness associated with narcolepsy or obstructive sleep apnea and has a PDUFA action date set for Dec. 20, 2018.

 Congress of European Sleep Research Society in Basel, Switzerland, Geert Mayer, MD, neurologist and sleep specialist, Philipps University of Marburg, sat down with 

 to discuss the results of a long-term study observing the safety and maintenance of efficacy of solriamfetol (JZP-110) for treatment of excessive sleepiness associated with narcolepsy or obstructive sleep apnea.

Mayer noted that the study proved solriamfetol, an additional wake-promoting agent, to be an efficacious medication that has good safety and long-term data and does not impact nighttime sleep. Long-term maintenance of efficacy was demonstrated after 1 year of treatment and the safety profile was consistent with prior placebo-controlled studies.

Future studies, Mayer concluded, need to be conducted to best determine long-term data and determine if the safety profile stays the same in say 5 or 10 years. Additionally, Mayer suggested that solriamfetol could possibly be used in other fields of excessive daytime sleepiness or even perhaps other neurodegenerative disorders.

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Long-term maintenance of efficacy was demonstrated with solriamfetol for treatment of excessive sleepiness with narcolepsy or obstructive sleep apnea.

Geert Mayer, MD: Safety, Efficacy of Solriamfetol for Excessive Sleepiness In Narcolepsy, OSA

“This was only one part, but you can conclude it has a good profile concerning [the] side effects, and it doesn’t have an impact to the adherence of OSA therapy, which is very important."

 Congress of the European Sleep Research Society in Basel Switzerland, Geert Mayer, MD, a neurologist and sleep specialist at Philipps University of Marburg, sat down with 

 to discuss one of the many presentations studying solriamfetol (JZP-101), a selective dopamine and norepinephrine reuptake inhibitor, in treatment of excessive sleepiness in narcolepsy and obstructive sleep apnea.

The phase III 12-week study aimed to evaluate whether solriamfetol had a different effect in participants adherent or nonadherent to primary obstructive sleep apnea devices and whether treatment with solriamfetol had an impact on primary therapy use.

The results concluded that there was no impact of the use of solriamfetol on the adherence in both the nonadherent and adherent groups, with no clinically significant changes in device usage throughout the study period. The study did report an Increased sleep latency on the MWT, dose-dependently as seen before, and reduced the score of the Epworth Sleepiness Scale. 

To conclude, solriamfetol has proven to be efficacious, is reported with a good safety profile and doesn’t have an impact on the adherence to the obstructive sleep apnea therapy. The FDA will review an application for solriamfetol (JZP-110) in December.

The neurologist and sleep specialist spoke about data from one of many studies investigating solriamfetol for treatment of narcolepsy and obstructive sleep apnea with remaining excessive daytime sleepiness.

Geert Mayer, MD

Articles

Geert Mayer, MD: Safety, Efficacy of Solriamfetol for Excessive Sleepiness In Narcolepsy, OSA

Geert Mayer, MD: Solriamfetol As Potential Therapy for Excessive Sleepiness in Narcolepsy, Obstructive Sleep Apnea