Clinical trial results

LUMRYZ^® was proven to reduce daytime symptoms of narcolepsy

Two people playing guitar in a living room

LUMRYZ was studied in a 13-week clinical trial

LUMRYZ was studied for the treatment of excessive daytime sleepiness (EDS) and cataplexy in a double-blind, placebo-controlled clinical trial of 212 people with narcolepsy.

Half of the people (107 people) took LUMRYZ
The other half (105 people) took placebo (a substitute that had no medicine in it)

A look at people in the trial:

Ages 16 to 72 years

The average age was 31 years old

76%

had narcolepsy with cataplexy, also known as narcolepsy type 1

24%

had narcolepsy without cataplexy, also known as narcolepsy type 2

Results were measured at Week 3 (88 people taking the 6 g dose of LUMRYZ), Week 8 (77 people taking the 7.5 g dose of LUMRYZ), and Week 13 (69 people taking the 9 g dose of LUMRYZ) and were compared with the people who were taking placebo. Those receiving LUMRYZ initially received 4.5 g for 1 week followed by 6 g for Weeks 2 to 3, 7.5 g for Weeks 4 to 8, and then 9 g for Weeks 9 to 13.

People taking LUMRYZ (9 g) at Week 13 experienced*:

Reduced EDS

People on LUMRYZ stayed awake 3x longer during daytime wakefulness tests (compared to 1x on placebo)

For 68 people taking LUMRYZ, wakefulness increased by an average of about 11 minutes during a daytime wakefulness test^† compared to start of treatment. For 78 people taking placebo, wakefulness increased by an average of about 5 minutes compared to start of study. People were able to stay awake for 5 minutes before receiving LUMRYZ compared to 15.5 minutes at Week 13.

Less cataplexy

57% fewer weekly cataplexy attacks for people with narcolepsy type 1 (compared to 25% taking placebo)

At Week 13, 55 people taking LUMRYZ had about 12 fewer cataplexy attacks per week vs where they started, compared to about 5 fewer per week in 62 people taking placebo.

Improved symptoms

73% were rated by clinicians to be much or very much improved^‡ (compared to 32% taking placebo)

At Week 13, in 69 people taking LUMRYZ and 79 people taking placebo compared to the start of the study.

*As seen in people taking a 9 g dose of LUMRYZ and compared to baseline results at the start of the trial.

^†Daytime wakefulness was measured after an overnight sleep study. People completed 5 daytime test sessions, each about 2 hours apart. During each 30-minute session, people were instructed to try to stay awake while seated in a quiet and comfortable room. The test measured how long they stayed awake before falling asleep.

^‡Healthcare providers rated each person's overall change in symptoms on a 7 item scale, ranging from "very much worse" to "very much improved."

EDS, excessive daytime sleepiness.