esponses rangefrom “very much improved” to “very much worse.” The co-primary efficacy endpoints werechange from baseline in MWT and ESS at Week 12. A pre-specified secondary endpoint waspercentage of subjects reported as improved (minimally, much, or very much) at Week 12 byPGIc.
A total of 239 patients with narcolepsy were randomized to receive SUNOSI 75 mg, 150 mg, or300 mg (two times the maximum recommended daily dose), or placebo once daily. Patientsrandomized to the 150-mg dose received 75 mg for the first 3 days before increasing to 150 mg.
Demographic and baseline disease characteristics were similar for the SUNOSI and placebo
groups. Median age was 34 years (range 18 to 70 years), 65% were female, 80% were Caucasian,14% were African American, and 3% were Asian. Approximately 51% of patientshad cataplexy. Compared to the placebo group, patients randomized to 150 mg SUNOSI showed statisticallysignificant improvements on the MWT (treatment effect difference: 7.7 minutes, Table 6) and onthe ESS (treatment effect difference: 3.8 points, Table 7) at Week 12. These effects wereapparent at Week 1 and consistent with the results at Week 12. The change on percentage ofsubjects reported as improved by PGIc was also statistically significant compared with placebo.
There were trends toward improvement in the SUNOSI 75-mg treatment group (Tables 6 and 7);however, these changes were not statistically significant. There was no evidence of differentialefficacy in patients with cataplexy and patients without cataplexy. Examination of subgroups byage, race, and sex did not suggest differences in response.
At Week 12, 150 mg of SUNOSI demonstrated improvements in wakefulness compared toplacebo as assessed in test sessions 1 (approximately 1 hour post-dose) through 5 (approximately9 hours post-dose) of the MWT (Figure 2). Nighttime sleep as measured with polysomnographywas not affected by the use of SUNOSI in Study 1.
Figure 2: Maintenance of Wakefulness Test Improvements in Test Sessions 1through 5 in Patients with Narcolepsy in Study 1 at Week 12
14.2 Obstructive Sleep Apnea (OSA)
The efficacy of SUNOSI in improving wakefulness and reducing excessive daytime sleepiness inpatients with OSA was demonstrated in a 12-week multi-center, randomized, double-blind,placebo-controlled study (Study 2; NCT02348606) in adults diagnosed with OSA according toICSD-3 criteria. The co-primary efficacy endpoints were change from baseline in MWT and ESSat Week 12; A pre-specified secondary endpoint was percentage of subjects reported asimproved (minimally, much, or very much) at Week 12 by PGIc.
A total of 476 patients with OSA were randomized to receive SUNOSI 37.5 mg, 75 mg, 150 mg,or 300 mg (two times the maximum recommended daily dose), or placebo once daily. Patientsrandomized to the 150-mg dose received 75 mg for the first 3 days before increasing to 150 mg.Demographic and baseline disease characteristics were similar for the SUNOSI and placebogroups. Median age was 55 years (range 20 to 75 years), 37% were female, 76% were Caucasian,19% were African American, and 4% were Asian.
Compared to the placebo group, patients randomized to 37.5 mg, 75 mg, and 150 mg SUNOSIshowed statistically significant improvements on the MWT (treatment effect difference: 4.5minutes, 8.9 minutes, and 10.7 minutes respectively; Table 6) and ESS (treatment effectdifference: 1.9 points, 1.7 points, and 4.5 points respectively; Table 7) at Week 12. These effec |
