Flamel Technologies Announces Positive Results of a First-in-Man Clinical Trial With Micropump Sodium Oxybate
07 4월 2014 - 8:30PM
Marketwired
Flamel Technologies Announces Positive Results of a First-in-Man
Clinical Trial With Micropump Sodium Oxybate
Potential Elimination of the "Middle-of-the-Night Dose"
Achieved; Current Study Continues to Allow for More Information on
Higher Doses; Conference Call With Management to Take Place at 8:45
AM EDT on April 7, 2014
LYON, FRANCE--(Marketwired - Apr 7, 2014) - Flamel Technologies
(NASDAQ: FLML) today announced that its First-in-Man (FIM) clinical
study in healthy volunteers using its proprietary Micropump®
technology applied to sodium oxybate has identified formulations
that demonstrate the potential to eliminate the second nighttime
dose for patients suffering from narcolepsy achieved the objective
of one single dose before bedtime for patients suffering from
narcolepsy, eliminating the need for a second dose. The
current dosing regimen for the standard of care, Xyrem® (sodium
oxybate), in the United States is two equal, divided doses: the
first dose at bedtime and the second dose 2.5 to 4 hours
later. The elimination of the second dose for narcolepsy
patients would not only provide more convenience, but may improve
the benefit sodium oxybate provides as there will be no disruption
to nighttime sleep. The potential for additional benefits,
including improved safety, will be studied.
The trial was designed as a 16 subject four-way crossover
evaluating three different formulations of Micropump sodium oxybate
and Xyrem at a nightly dose of 4.5g (two doses of 2.25g for Xyrem)
with an extension phase at 6g for successful Micropump
formulations. Each subject consumed a standard meal two hours
prior to dosing. Subjects were instructed to maintain a
consistent meal time and dosing schedule throughout the
study. When a subject took Xyrem they were instructed to take
the second dose 4 hours after the first dose. Two subjects
dropped out of the study prior to the completion of the 4.5g dosing
portion for reasons unrelated to drug. The key data for the 14
evaluable subjects at 4.5g are:
- Onset of action similar to Xyrem
- Cmax lower than Xyrem
- Mean blood concentration (ug/ml) at hours 7 and 8 similar to
Xyrem
For the extension phase of the study, two formulations were
moved forward for dosing at 6g. Thirteen subjects were
evaluable as one subject dropped out for a reason unrelated to
drug. The profiles for both formulations were consistent with
expectations.
The current study will continue to treat subjects at higher
doses.
Given these results, Flamel plans to begin a new clinical study
before the end of 2014 in a larger number of subjects further
evaluating its formulations as well as certain pharmacodynamic
endpoints. This study is not expected to be a registration
study. Flamel plans to meet with regulatory authorities prior
to embarking upon registration studies which are expected to begin
prior to the end of 2015.
Flamel's Micropump technology is protected by intellectual
property through at least 2025 in the United States. Micropump
is a proven drug delivery platform for the oral delivery of small
molecules.
Narcolepsy is a sleep disorder involving irregular patterns in
Rapid Eye Movement (REM) sleep and significant disruptions of the
normal sleep/wake cycle. People with narcolepsy experience
excessive daytime sleepiness, sleep attacks, cataplexy, sleep
paralysis, hallucinations and disrupted nighttime sleep.
Xyrem® is sold in the United States by Jazz Pharmaceuticals plc,
in Canada by Valeant Canada Limited (via license from Jazz) and in
twenty-two EU countries and Mexico by UCB Pharma Limited (via
license from Jazz).
A conference call to discuss these results and other updates is
scheduled for 8:45 AM Eastern Daylight Time on April 7,
2014. A question and answer period will follow management's
prepared remarks. To participate in the conference call,
investors are invited to dial 888-857-6930 (U.S.) or 719-457-2615
(international). The conference ID number is 9695267. The
conference call webcast may be accessed at www.flamel.com. A replay
of the webcast will be archived on Flamel's website for 90 days
following the call.
About Flamel Technologies. Flamel Technologies SA's (NASDAQ:
FLML) business model is to blend high-value internally developed
products with its leading drug delivery capabilities. The Company
has a proprietary pipeline of niche specialty pharmaceutical
products, while its drug delivery platforms are focused on the goal
of developing safer, more efficacious formulations of drugs to
address unmet medical needs. Its partnered pipeline includes
biological and chemical drugs formulated with its Medusa™ and
Micropump® (and its applications to the development of liquid
formulations, i.e. LiquiTime® and of abuse-deterrent formulations
Trigger Lock™) proprietary drug delivery platforms. Several
Medusa-based products have been successfully tested in clinical
trials. The Company has developed products and manufactures
Micropump-based microparticles under FDA-audited GMP guidelines.
Flamel Technologies has collaborations with a number of leading
pharmaceutical and biotechnology companies, including
GlaxoSmithKline (Coreg CR®, carvedilol phosphate). The Company is
headquartered in Lyon, France and has operations in St. Louis,
Missouri, USA, and manufacturing facilities in Pessac, France.
Additional information may be found at www.flamel.com.
This release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including certain plans, expectations, goals and projections
regarding financial results, product developments and technology
platforms. All statements that are not clearly historical in nature
are forward-looking, and the words "anticipate," "assume,"
"believe," "expect," "estimate," "plan," "will," "may," and similar
expressions are generally intended to identify forward-looking
statements. All forward-looking statements involve risks,
uncertainties and contingencies, many of which are beyond our
control that could cause actual results to differ materially from
those contemplated in such forward-looking statements. These risks
include risks that the launch of Bloxiverz will not be as
successful as anticipated; our ability to bring other R&D
projects of the former Éclat Pharmaceuticals to market may be
unsuccessful; FDA may not take action on the status of unapproved
versions of neostigmine still on the market; clinical trial results
may not be positive or our partners may decide not to move forward;
products in the development stage may not achieve scientific
objectives or milestones or meet stringent regulatory requirements;
products in development may not achieve market acceptance;
competitive products and pricing may hinder our commercial
opportunities; we may not be successful in identifying and pursuing
opportunities to develop our own product portfolio using Flamel's
technology; and the risks associated with our reliance on outside
parties and key strategic alliances. These and other risks are
described more fully in Flamel's Annual Report on Form 20-F for the
year ended December 31, 2012 that has been filed with the
Securities and Exchange Commission (SEC). All forward-looking
statements included in this release are based on information
available at the time of the release. We undertake no obligation to
update or alter our forward-looking statements as a result of new
information, future events or otherwise.
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