Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ). FDA label
Also known as Extended-release sodium oxybate, oxybate, FT218
Lumryz · 4 trials · 9 indications
Change in total ESS score
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
Participants will be asked at the end of the study whether participants prefer extended-release sodium oxybate vs sodium oxybate vs calcium, magnesium, potassium and sodium oxybates
| Arm | Type | Description |
|---|---|---|
| FT218 | EXPERIMENTAL | FT218 at stable dose (selected during earlier titration) administered orally once nightly |
| Placebo | PLACEBO_COMPARATOR | Placebo equivalent administered orally once nightly |
| Sodium Oxybate | EXPERIMENTAL | Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate. |
| Extended-release sodium oxybate | EXPERIMENTAL | Participants in this arm will take extended-release sodium oxybate |
| Non-extended-release oxybates | ACTIVE_COMPARATOR | Participants in this arm will take non-extended-release sodium oxybate |
| Name | Type | Description |
|---|---|---|
| FT218 | DRUG | Sodium oxybate for extended-release oral suspension |
| Placebo | OTHER | Matched placebo equivalent for oral suspension |
| Extended-release sodium oxybate | DRUG | Participants will take Extended-release sodium Oxybate (Lumryz) 4.5-9 g oral suspension in approximately ⅓ cup of water orally once a day before bedtime. Dosage of Lumryz will be the same as the equivalent total dose of the Non-Extended-release Oxybate (Xywav or Xyrem) that participants use before starting the study |
| Non-extended-release oxybates | DRUG | Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and another dose 2-4 hours later) at the same dose of Xyrem or Xywav that participants use before starting the study will be continued to compare with Extended-release sodium Oxybate (Lumryz) |
Inclusion Criteria: * Primary diagnosis of idiopathic hypersomnia * Total ESS score at Screening \> 11 if not on prior oxybate * Average nightly total sleep time of \> 7 hours * May use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to Screening, and remain...
Lumryz is being developed for the treatment of narcolepsy type 1 (NT1). It is an extended-release formulation of sodium oxybate being studied in pediatric patients aged 7 years and older. The program is in Phase 2 clinical development.
Lumryz is developed by Avadel Pharmaceuticals plc, which trades on the Nasdaq under the ticker AVDL. Avadel is the sponsor of the clinical program evaluating extended-release sodium oxybate in narcolepsy type 1.
Lumryz is in Phase 2 clinical development. The ongoing trial is a Phase 2 study of extended-release sodium oxybate in children with narcolepsy type 1. It is investigational and has not been approved by the FDA for this pediatric indication.
Lumryz is being evaluated in one active clinical trial, NCT06809803, titled Extended-release Sodium Oxybate in Children. The Phase 2 study is currently recruiting in the United States and plans to enroll 36 participants aged 7 years and older with narcolepsy type 1.
Yes. Lumryz is also known as extended-release sodium oxybate, or simply oxybate. These names refer to the same investigational product being developed by Avadel Pharmaceuticals for narcolepsy type 1.
The Phase 2 trial NCT06809803 is an active-controlled study of extended-release sodium oxybate in children with narcolepsy type 1. It is randomized but not double-blind, is recruiting in the United States, and has a planned enrollment of 36 participants.