For patients on obstructive sleep apnea therapy who still experience excessive sleepiness, a phase 3 study of the norepinephrine-dopamine reuptake inhibitor shows promise.
JZP-110, a norepinephrine-dopamine reuptake inhibitor from Jazz Pharmaceuticals plc currently under evaluation for its effect on excessive sleepiness in adults with obstructive sleep apnea (OSA), could significantly improve function and work productivity, according to an abstract published in the journal Sleep. The results, presented in a poster session at the SLEEP 2017 conference, indicate the efficacy of JZP-110 in treating these symptoms of excessive sleepiness in OSA patients.
JZP-110 has already shown promising results for patients with narcolepsy and will also be evaluated for its efficacy in treating symptoms for Parkinson’s patients.
During this phase 3 study, functional status was measured using the Functional Outcomes of Sleep questionnaire and work productivity/overall activity impairment were assessed using the Work Productivity and Activity Impairment questionnaire for Specific Health Problems questionnaire.
The results are encouraging news for those with OSA who struggle with daily activities and low work performance seeking additional options in treating their excessive sleepiness—in particular, those patients who still experience daytime sleepiness while being compliant with an OSA therapy such as CPAP.
“Of course, when we initiate the CPAP we hope the patient gets better, but that isn’t always the case for various reasons,” says Richard Bogan, MD, FCCP, FAASM, medical director, SleepMed of South Carolina, an author of the abstract. “It may be anywhere north of 10% of patients who are treated with CPAP that still experience daytime sleepiness.”
According to Bogan, who is also associate clinical professor, University of South Carolina School of Medicine and associate clinical professor, Medical University of South Carolina, this trial was one of the first times the researchers have had a chance to really look at improving downstream effects of excessive sleepiness like workplace performance, absenteeism, presenteeism, functional improvement, and quality of life. “Those measures did reach statistical significance,” he says, “and what we think is clinical relevance in terms of improving these individuals—not only their sleepiness, but to where workplace performance and functional quality of life improve.”
Bogan emphasizes the need for clinicians to be striving for more effective therapeutic solutions for the sake of their patients who are suffering in spite of their current treatment. “Clinicians are constantly looking for therapeutic options because some of the current ones we use to treat our patients are not always effective,” he says. “Sleepy individuals are very difficult to treat, so we’re always looking for improvement in terms of effect size.”
As for the future of JZP-110, Bogan is hoping to continue evaluating its efficacy in other areas of a patient’s quality of life. “We’d like to investigate the effect on mood and cognition. We’d be very interested in knowing what the downstream effects on those areas would be from improving patients’ sleepiness.”
Dillon Stickle is associate editor for Sleep Review.