Avadel to Present New Data on Once-Nightly Sodium Oxybate at SLEEP 2019 Conference
June 04 2019 - 7:00AM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
developing FT218 for narcolepsy, today announced it will present
two posters at the 33rd Annual Meeting of the Associated
Professional Sleep Societies being held in San Antonio, Texas, from
June 8-12, 2019. The posters highlight pharmacokinetic (PK) data
for its investigational, once-nightly controlled-release sodium
oxybate (FT218), including a head-to-head PK comparison to
twice-nightly sodium oxybate and dose proportionality across three
doses.
“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 Jordan Dubow, MD, Chief Medical Officer
of Avadel Pharmaceuticals. “Furthermore, results from our dose
proportionality study showed that FT218 exhibits predictable
increases in plasma levels with increasing doses, consistent with
the PK profile desired for a once-nightly sodium oxybate
formulation. We are excited about the potential benefits of our
once-nightly formulation and look forward to completion of the
Phase 3 REST-ON trial, which is nearly two-thirds complete.”
Poster Presentations:
Poster 0609, presented Sunday, June 9, 5:15 – 7:15 p.m. CDT
“Pharmacokinetics and Formulation Selection of FT218, an
Investigational Controlled-Release Sodium Oxybate Formulation
Designed for Once-Nightly Dosing”
Poster 0610, presented Sunday, June 9, 5:15 – 7:15 p.m. CDT
“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 (EDS) and cataplexy in patients
with narcolepsy is currently being evaluated in the Phase 3,
multi-centered, double-blind, placebo-controlled REST-ON trial,
which is expected to complete enrollment in 2020. Poster reprints
and REST-ON information will be available at Avadel’s Booth #1027
in the Exhibit Hall during the SLEEP 2019 conference.
About Avadel Pharmaceuticals
plc:
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a branded specialty
pharmaceutical company. The Company’s primary focus is on the
development and potential FDA approval for FT218, which is in a
Phase 3 clinical trial for the treatment of narcolepsy patients
suffering from excessive daytime sleepiness (EDS) and cataplexy. In
addition, Avadel develops and markets a portfolio of sterile
injectable drugs used in the hospital setting. For more
information, please visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking
Statements
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 FDA
ultimately approves such product, the approval may not include any
period of market exclusivity; (ii) the risk that, even if we
successfully complete the development of FT218 and begin its
commercialization, it may not receive market acceptance, or new,
announced alternative products in development may be approved and
may be viewed as more effective than FT218 or otherwise receive
greater market acceptance; (iii) the risk that servicing our
$143.75 million Exchangeable Senior Notes due 2023 may require a
significant amount of cash, and we may not have sufficient cash or
the ability to raise the funds necessary to settle exchanges of
such 2023 Notes in cash, repay the 2023 Notes at maturity, or
repurchase the 2023 Notes as required following a “fundamental
change” event described in the indenture governing the 2023 Notes;
and (iv) the other risks and uncertainties described in the “Risk
Factors” section of Part I, Item 1A of our Annual Report on Form
10-K for the year ended December 31, 2018 which we filed with the
Securities and Exchange Commission on March 15, 2019.
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: Michael F. KananChief Financial Officer Phone: (636)
449-1844Email: mkanan@avadel.com
Alex GrayBurns McClellan Phone: (212) 213-0006Email:
agray@burnsmc.com
Source: Avadel Pharmaceuticals plc
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