page-decoration REQUEST A REPRESENTATIVE

Safety and Tolerability of LUMRYZ1,2*

The majority of treatment-emergent adverse events (TEAEs) (87%) were considered mild or moderate in severity.3

Adverse reactions occurring in ≥2% of LUMRYZ participants and greater than placebo1

Adverse Reaction Placebo
(N=105)
%
LUMRYZ
4.5 g (N=107)
%
LUMRYZ
6 g (N=97)
%
LUMRYZ
7.5 g (N=88)
%
LUMRYZ
9 g (N=77)
%
Vomiting 2 3 3 6 5
Nausea 3 6 8 7 1
Weight Decreased 0 1 0 0 4
Decreased Appetite 0 4 4 3 3
Dizziness 0 6 4 6 5
Somnolence 1 0 1 2 4
Headache 6 7 5 6 0
Enuresis 0 2 4 9 9
Anxiety 1 3 1 3 1
Somnambulism 0 1 2 0 0

In REST-ON, 15.9% of patients treated with LUMRYZ discontinued because of adverse reactions, compared with 1.9% of patients who received placebo.1

There were no clinically meaningful changes from baseline blood pressure or heart rate.2

*All but 1 patient included in the safety study were oxybate-naïve. In 2018, protocol was amended to allow prior use of sodium oxybate of 4.5 g or less, for <2 weeks and ≥1 year prior to study entry.

Adverse reactions over time2

Adverse drug reactions (ADRs) in the REST-ON study were shown to decrease over time.

Incidence of related TEAEs over time for LUMRYZ

Incidence of related TEAEs over time for LUMRYZ graph Incidence of related TEAEs over time for LUMRYZ graph Incidence of related TEAEs over time for LUMRYZ graph - Nausea Incidence of related TEAEs over time for LUMRYZ graph - Nausea Incidence of related TEAEs over time for LUMRYZ graph - Vomiting Incidence of related TEAEs over time for LUMRYZ graph - Vomiting Incidence of related TEAEs over time for LUMRYZ graph - Decreased Appetite Incidence of related TEAEs over time for LUMRYZ graph - Decreased Appetite Incidence of related TEAEs over time for LUMRYZ graph - Headache Incidence of related TEAEs over time for LUMRYZ graph - Headache Incidence of related TEAEs over time for LUMRYZ graph - Dizziness Incidence of related TEAEs over time for LUMRYZ graph - Dizziness Incidence of related TEAEs over time for LUMRYZ graph - Enuresis Incidence of related TEAEs over time for LUMRYZ graph - Enuresis Incidence of related TEAEs over time for LUMRYZ graph - Anxiety Incidence of related TEAEs over time for LUMRYZ graph - Anxiety

The incidence of adverse reactions in patients treated with LUMRYZ increased with each up-titrated dose, and then typically decreased over time as their body adjusted to the medicine.

References:

  1. References: 1. LUMRYZ (sodium oxybate for extended-release oral suspension). Prescribing Information. Chesterfield, MO: Avadel Pharmaceuticals. 2. Kushida CA, Shapiro CM, Roth T, et al. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022;45(6):1-11. 3. Avadel, Data on file.