Approval Probability
TA Base Rate
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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 LUMRYZ
FT218 · 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...
FT218 is an investigational small molecule being developed for the treatment of narcolepsy, excessive daytime sleepiness, cataplexy, and idiopathic hypersomnia. It is a once-nightly formulation of sodium oxybate. FT218 is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
FT218 is being developed by Avadel Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVDL. The company is conducting Phase 3 clinical trials to evaluate the safety and efficacy of FT218 in patients with narcolepsy and idiopathic hypersomnia.
FT218 is in Phase 3 clinical development. Multiple Phase 3 trials have been completed, including studies in narcolepsy and idiopathic hypersomnia. FT218 is an investigational drug and has not received FDA approval. It remains in clinical development as the company analyzes trial results.
FT218 has been studied in three completed Phase 3 trials. NCT02720744 evaluated once-nightly sodium oxybate for excessive daytime sleepiness and cataplexy in narcolepsy with 212 participants. NCT04451668 was an open-label study in narcolepsy with 184 participants. NCT06525077, known as REVITALYZ, assessed safety and efficacy in idiopathic hypersomnia with 157 participants.
FT218 is a once-nightly formulation of sodium oxybate, which acts on the central nervous system to improve sleep architecture and reduce symptoms of narcolepsy such as excessive daytime sleepiness and cataplexy. The extended-release design is intended to provide a full night of therapeutic coverage with a single bedtime dose.