Signifier Medical Technologies LLC today released the results of an analysis of real-world patient adherence data for its lead product, eXciteOSA, the first daytime therapy indicated to treat primary snoring and mild obstructive sleep apnea (OSA).

The data demonstrated that real-world patients in the United States prescribed eXciteOSA used therapy on over 80% of days over the first six weeks of treatment. In a release, Signifier notes that clinical trials and observational studies indicate 25% to 46% of patients are not adherent to PAP for sleep apnea, and there is also evidence those with mild OSA are 34% less likely to be adherent to PAP than those with moderate/severe OSA.

In the white paper, “A descriptive analysis of objectively monitored real-world adherence to eXciteOSA,” Signifier analyzed data from 3,561 individual patients in the United States up until June 2022. The results demonstrate that patients have used eXciteOSA therapy on over 80% of days during the first six weeks of treatment. Signifier reported that real-world patients use therapy for an average of 680 minutes (11:20 hh:mm) within the first six weeks, representing over 80% of the total duration prescribed (840 minutes). The dataset represents the entire population of US-based patients who started therapy on eXciteOSA over the 15-month period from April 2021 to June 2022. 

“The real-world data released today suggests eXciteOSA patients adhere strongly to the therapy. Sleep apnea is a serious condition, and adherence to treatment is both a challenge and a requirement. We’re delighted that eXciteOSA appears to become a part of a patient’s daily routine, and we’re thrilled to provide a treatment that is easy-to-use and allows patients to get a good night’s rest without hoses and masks. We understand patients’ desire for effective treatments that fit their lifestyle,” says Jessie Bakker, MS, PhD, executive vice president of Medical Affairs at Signifier, in a release. 

Past studies have shown eXciteOSA is associated with reductions in both objectively-measured and bed-partner reported snoring, along with significant improvements in disease severity, the Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index. Clinical trial participants experienced an average 33% reduction in their AHI overall, with a 52% reduction evident in the responder subset. Following a successful FDA submission through the de novo pathway, eXciteOSA was launched in the United States in early 2021 as the first daytime therapy product indicated for treatment of primary snoring and mild OSA. 

“The body of evidence regarding the efficacy and adherence of eXciteOSA is growing and we continue to evaluate and learn about the utility and impact this therapy can have on the lives of those patients living with sleep apnea and their partners. We’re looking forward to the results of our ongoing clinical trials including a study of patients with moderate OSA,” said Phil Hess, chief operating officer of Signifier, in a release.

Signifier has randomized trials in progress to understand the potential placebo effect, the impact of therapy relative to usual care without treatment, and the impact of therapy amongst those with moderate obstructive sleep apnea.