Sydney, a real patient with narcolepsy on LUMRYZ, feeling more awake to make music with friends
Sydney was compensated by Alkermes.
Individual results may vary.
REFRESH evaluated the real-world effectiveness of LUMRYZ in patients with narcolepsy1
REFRESH followed patients with different treatment histories1
REFRESH was a prospective, multicenter, observational study of LUMRYZ used in clinical practice for the treatment of narcolepsy, following patients from 3 treatment groups1*:
- Patients who were oxybate-naïve at baseline (51%; n=36)1
- Patients who had previously discontinued another oxybate therapy who started on LUMRYZ (14%; n=10)1
- Patients taking XYREM®/XYWAV® at baseline (35%; n=25)1†
- *LUMRYZ dosing followed product labeling (eg, titrated at investigator discretion within a range of 4.5-9 g). Included in the study assessments were changes in ESS scores, PGI-C, and CGI-C. Clinical assessments for ESS scores were conducted at Weeks 1 to 6, 8, 10, 12, 14, and 16; PGI-C and CGI-C were conducted at Week 16.1
- †XYREM® (sodium oxybate) oral solution and XYWAV® (calcium, magnesium, potassium, and sodium oxybates) oral solution.2,3
Limitations1:
- The relatively small number of participants in this study may limit the application of results to the broader population. There was no specific sample size requirement for analysis of the study outcomes
- The lack of blinding and absence of a placebo control introduces the potential for bias; data were tabulated as observed
- Doses of XYREM/XYWAV for switch group patients were not collected and maintenance status on entering REFRESH was not documented
Observed ESS score reductions in patients who started LUMRYZ
6.6. mean reduction for patients not on an oxybate at baseline
3.1 mean reduction for patients on XYWAV/XYREM at baseline
Limitations: This is an observational study with no control group. All statistical analyses are descriptive in nature and no conclusions on efficacy or safety can be made. The study was not designed to compare the safety and efficacy of LUMRYZ with other medications to treat narcolepsy.1
Clinician Global Impression of Change with LUMRYZ treatment
CGI-C Results in LUMRYZ Patients at Week 161
of patients who were not on an oxybate at baseline were rated as improved on LUMRYZ (n=29)
- 12% (n=4) had no change on LUMRYZ
- 0% (n=0) were worse on LUMRYZ
of patients who were on XYREM/XYWAV at baseline were rated as improved on LUMRYZ (n=16)
- 10% (n=2) had no change on LUMRYZ
- 14% (n=3) were worse on LUMRYZ
- In the CGI-C, a clinician provided a standardized rating at month 4 classifying patients' overall symptom change as very much improved, much improved, minimally improved, no change, minimally worse, or very much worse.
Limitations: This is an observational study with no control group. All statistical analyses are descriptive in nature and no conclusions on efficacy or safety can be made. The study was not designed to compare the safety and efficacy of LUMRYZ with other medications to treat narcolepsy.1
Patient Global Impression of Change with LUMRYZ treatment
PGI-C results in LUMRYZ patients at Week 161
of patients who were not on an oxybate at baseline were rated as improved on LUMRYZ (n=31)
- 6% (n=2) had no change on LUMRYZ
- 3% (n=1) were worse on LUMRYZ
of patients who were on XYREM/XYWAV at baseline were rated as improved on LUMRYZ (n=14)
- 10% (n=2) had no change on LUMRYZ
- 20% (n=4) were worse on LUMRYZ
- In the PGI-C, participants provided a standardized rating at month 4 classifying their overall symptom change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Limitations: This is an observational study with no control group. All statistical analyses are descriptive in nature and no conclusions on efficacy or safety can be made. The study was not designed to compare the safety and efficacy of LUMRYZ with other medications to treat narcolepsy.1
Adverse drug reactions observed in REFRESH1
Tolerability data were reported via a symptom-directed adverse reaction interview asking whether participants experienced adverse reactions from a predefined list of common adverse reactions described in the LUMRYZ prescribing information (ie, nausea, dizziness, headache, vomiting, decreased appetite, decreased weight, and enuresis).1,4
of observed adverse reactions were mild or moderate in severity1
- 3 patients (4%) ended treatment early due to tolerance concerns1
- ‡In total, 13 severe adverse reactions were documented: dizziness (5 events), nausea (4 events), vomiting (3 events), and enuresis (1 event).1
- §From the symptom-directed adverse reaction interview.1
Limitations: The symptom-directed interview was limited to adverse reactions described in the LUMRYZ prescribing information, which did not allow for the identification of novel adverse reactions.1
I’m not defined by my sleepiness. I’m more awake to make the music I love”
-Sydney
Hear firsthand from patients about their experiences with LUMRYZ
Sydney was compensated by Alkermes. Individual results may vary.
Most patients with commercial insurance pay $0 when using the LUMRYZ Co-pay Program1ǁ
- ǁThis offer is valid only for patients who have commercial insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Additional terms and conditions apply. Download the full terms and conditions of the co-pay program.
XYREM® and XYWAV® are registered trademarks of Jazz Pharmaceuticals, Inc.
CGI-C, Clinical Global Impression of Change; ESS, Epworth Sleepiness Scale; PGI-C, Patient Global Impression of Change; SD, standard deviation.
References: 1. Avadel, Data on file. 2. XYREM® (sodium oxybate). Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 3. XYWAV® (calcium, magnesium, potassium, and sodium oxybates). Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 4. LUMRYZ® (sodium oxybate for extended-release oral suspension). Prescribing Information. Chesterfield, MO: Avadel Pharmaceuticals.
