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Avadel Pharmaceuticals Announces Pharmacokinetic (PK) Data for Once-Nightly FT218 that will be Included in an Oral Presentation at the World Sleep 2019 Congress on September 25th
The key PK data points from these four studies demonstrated:
- Once-nightly FT218 at 4.5g and 6g demonstrated lower overall maximum plasma concentrations (Cmax) and equivalent exposure (AUC) to twice-nightly sodium oxybate, as well as similar morning plasma levels (C8h) and variability to twice-nightly sodium oxybate.
- The Cmax of FT218 was dose proportional and AUC was slightly higher than dose proportional, which demonstrates the predictability of FT218 as dosing increases.
- Consistent with the expectations of a sodium oxybate product, FT218 has lower exposure and lower maximum plasma concentration in the Fed versus the Fasted State.
- FT218 up to the 9g dose level was generally well-tolerated. Further, observed Adverse Events for the 4.5 and 6g doses of FT218 were consistent with those known for sodium oxybate and appeared comparable to the Adverse Effects for corresponding strengths of twice-nightly sodium oxybate in the study.
According to Dr. Thorpy, “The totality of the pharmacokinetic data from these four Phase 1 studies demonstrates that Avadel has developed a formulation of sodium oxybate that exhibits a pharmacokinetic profile desirable for once-nightly dosing.”
“Based on the results of these four studies, we are confident that the ongoing Phase 3 REST-ON study of FT218 will demonstrate efficacy in the treatment of both excessive daytime sleepiness and cataplexy in patients with narcolepsy. We currently expect to complete enrollment of the Phase 3 trial by the end of this year, with top line data estimated to be available in the second quarter of 2020,” said
In addition to previously published pharmacokinetic data, information on the ongoing Phase 3 REST-ON study of FT218 will be available at Avadel’s Booth #113 in the Exhibit Hall during the World SLEEP 2019
The four Phase 1 studies include:
A comparative, open-label, randomized, 2-period, 2-sequence, crossover study to assess the bioavailability of FT218 6g compared to twice-nightly sodium oxybate 6g (2 divided doses of 3g) in 28 healthy volunteers. Subjects were randomized to receive either FT218 6g followed by twice-nightly sodium oxybate 6g or twice-nightly sodium oxybate followed by FT218 6g with a minimum of a 3-day washout between doses.
An open-label, randomized, single-dose, two treatment (Fed vs. Fasted), two-period, two-sequence crossover study to assess the effect of food on the pharmacokinetics of FT218 in 16 healthy volunteers. Subjects were randomized to receive either FT218 6g in the Fed (30-minutes after a standardized high-fat breakfast) followed by FT218 in the Fasted (10-hours after an overnight fast) or FT218 6g in the Fasted state followed by FT218 6g in the Fed state with a minimum of a 3-day washout between doses.
A pharmacokinetics and formulation selection pilot study that was designed as a four-way crossover study in 16 healthy volunteers, evaluating three proprietary once-nightly formulations of Micropump™ controlled-release (CR) sodium oxybate (FT218) versus twice-nightly immediate-release (IR) sodium oxybate at a nightly dose of 4.5g (two doses of 2.25g for IR sodium oxybate). Each subject consumed a standard meal two hours prior to dosing. Subjects receiving the twice-nightly sodium oxybate were administered the second dose 4 hours after the first dose.
A dose proportionality study that was an open-label, single ascending dose, three-sequential-period study in 20 healthy volunteers. Subjects received three separate single-dose administrations of FT218 at bedtime, two hours post-evening meal, in a sequential order of 4.5g, 7.5g and 9g with a minimum 7-day washout between doses.
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the
About Avadel Pharmaceuticals plc
Cautionary Disclosure Regarding Forward-Looking Statements
This press release contains “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements (which may be identified by words such as “will,” “look forward,” “should,” “planned” and “anticipate”) are not statements of historical facts regarding FT218, the
|Contacts:||Michael F. Kanan|
|Chief Financial Officer|
|Phone: (636) 449-1844|
|LifeSci Advisors, LLC|
|Phone: (212) 915.2564|
Source: Avadel Pharmaceuticals plc