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Avadel to Present New Data on Once-Nightly Sodium Oxybate at SLEEP 2019 Conference
“Our once-nightly controlled-release sodium oxybate demonstrated lower overall peak plasma concentrations (Cmax) and similar total exposures (AUC), compared to twice-nightly sodium oxybate in a head-to-head study,” said
Poster Presentations:
Poster 0609, presented
“Pharmacokinetics and Formulation Selection of FT218, an Investigational Controlled-Release Sodium Oxybate Formulation Designed for Once-Nightly Dosing”
Poster 0610, presented
“Pharmacokinetics and Dose Proportionality of FT218, an Investigational Controlled-Release Sodium Oxybate Formulation Designed for Once-Nightly Dosing”
The pharmacokinetics and formulation selection pilot study 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 IR sodium oxybate, were administered the second dose 4 hours after the first dose. Two subjects dropped out of the study prior to the completion. The key data for the 14 evaluable subjects demonstrates:
- FT218 exhibited rapid initial absorption comparable to twice-nightly IR sodium oxybate
- FT218 demonstrated a lower overall Cmax than twice-nightly IR sodium oxybate
- FT218 mean blood concentrations (ug/ml) at 8 hours were similar to that of twice-nightly IR sodium oxybate
- Safety and tolerability were similar across administrations
The dose proportionality study was an open-label, single-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. PK profiles were assessed for dose proportionality across the three doses and the results demonstrated:
- FT218, at each dose, exhibited PK profiles consistent with those desired for once-nightly dosing
- Dose proportionality was maintained for Cmax across the dosage range
- Safety profile was consistent with what is known for sodium oxybate
The safety and efficacy of FT218 for the once-nightly treatment of excessive daytime sleepiness (
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This press release may include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. In some cases, forward-looking statements can be identified by the use of words or phrases such as “will,” “as we continue,” “objective,” “future success,” “potential, “opportunity” and similar expressions, and the negatives thereof (if applicable).
Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include (i) the risk that we could experience failure or delay in completing the Phase 3 “REST-ON” clinical trial for our FT218 product, or that if the
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this press release.
Contacts:
Chief Financial Officer Phone: (636) 449-1844
Email: mkanan@avadel.com
Burns McClellan Phone: (212) 213-0006
Email: agray@burnsmc.com
Source:
Source: Avadel Pharmaceuticals plc