Quviviq

The efficacy of QUVIVIQ was evaluated in two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, Study 1 (NCT03545191) and Study 2 (NCT03575104).

A total of 1854 patients with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5^®) insomnia were randomized to receive QUVIVIQ or placebo once daily, in the evening, for 3 months. Study 1 randomized 930 subjects to QUVIVIQ 50 mg (N = 310), 25 mg (N = 310) or placebo (N = 310). Study 2 randomized 924 subjects to QUVIVIQ 25 mg (N = 309), 10 mg (N = 307), or placebo (N = 308). The 10 mg dose is not an approved dose.

At the end of the 3-month treatment period, both studies included a 7-day placebo run-out period, after which patients could enter a 9-month, double-blind, placebo-controlled extension study (Study 3, NCT03679884).

In Study 1, patients had a mean age of 55.4 years (range 18 to 88 years), with 39.1% of subjects ≥ 65 years of age, including 5.8% ≥ 75 years of age. Patients were identified as female or male and by US census-based racial and ethnic categories. The percentages of patients in the respective categories were: female sex (67.1%), White (90%), Black or African American (8%), Asian (1.0%), or Other race (< 1%).

In Study 2, patients had a mean age of 56.7 years (range 19 to 85 years), with 39.3% of subjects ≥ 65 years of age, including 6.1% ≥ 75 years of age. Patients were identified as female or male and by US census-based racial and ethnic categories. The percentages of patients in the respective categories were: female sex (69.0%), White (88%), Black or African American (8%), Asian (4%), or Other race (< 1%).

Primary efficacy endpoints for both studies were the change from baseline to Month 1 and Month 3 in Latency to Persistent Sleep (LPS) and Wake After Sleep Onset (WASO), measured objectively by polysomnography in a sleep laboratory. LPS is a measure of sleep induction and WASO is a measure of sleep maintenance.

Secondary endpoint included in the statistical testing hierarchy with Type 1 error control was patient-reported Total Sleep Time (sTST), evaluated every morning at home using a validated Sleep Diary Questionnaire (SDQ).

In Study 1, doses of 25 and 50 mg QUVIVIQ showed a statistically significant improvement vs placebo on polysomnography (LPS, WASO) and self-reported total sleep (sTST), at Month 1 and Month 3 (Table 4).

In Study 2, QUVIVIQ 25 mg showed a statistically significant improvement vs placebo on WASO and sTST at Month 1 and Month 3 (Table 5). QUVIVIQ 10 mg did not show a statistically significant improvement on LPS, WASO, or sTST at Month 1 or Month 3.

The efficacy of QUVIVIQ was similar across subgroups based on age, sex, race, and region.

The effects of QUVIVIQ on LPS, WASO, and sTST were observed at Month 1 and were maintained through Month 3. The change from baseline of sTST by week in Study 1 is presented in Figure 4.