Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT218 · 3 trials · 8 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
| 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. |
| Name | Type | Description |
|---|---|---|
| FT218 | DRUG | Sodium oxybate for extended-release oral suspension |
| Placebo | OTHER | Matched placebo equivalent for oral suspension |
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 excessive daytime sleepiness, idiopathic hypersomnia, and narcolepsy. It is a once-nightly formulation of sodium oxybate. FT218 is currently in Phase 3 clinical development and has not been approved by the FDA.
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 for the treatment of narcolepsy and idiopathic hypersomnia.
FT218 is in Phase 3 clinical development. It has completed three Phase 3 trials, including studies in narcolepsy and idiopathic hypersomnia. FT218 is an investigational drug and has not received FDA approval. Its safety and efficacy have not been fully established.
FT218 has completed three Phase 3 clinical trials: NCT02720744, a placebo-controlled study in narcolepsy with 212 participants; NCT04451668, an open-label study in narcolepsy with 184 participants; and NCT06525077, a study in idiopathic hypersomnia with 157 participants. All trials are completed.
FT218 is a once-nightly formulation of sodium oxybate, the active ingredient. It is designed to be taken once at bedtime, whereas other sodium oxybate products may require multiple doses. FT218 is being studied for the treatment of narcolepsy and idiopathic hypersomnia.