Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update
JZP-386 is a deuterium-containing analog of sodium oxybate. The Phase 1 program is comparing JZP-386 to sodium oxybate versus placebo in healthy volunteers. The companies expect that the results from the upcoming Phase 1 trial will inform the next steps in the development program for JZP-386.
Sodium oxybate is the active ingredient in Xyrem®, a prescription
medicine marketed in
About
About
About Xyrem
Xyrem® (sodium oxybate) oral solution, CIII, is indicated for the
treatment of cataplexy in narcolepsy and for the treatment of
| IMPORTANT SAFETY INFORMATION |
|
XYREM is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in XYREM-treated patients. Almost all of the patients who received XYREM during clinical trials in narcolepsy were receiving CNS stimulants.
XYREM is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression, abuse, and misuse, XYREM is available only through a restricted distribution program called the XYREM Success Program®, using a centralized pharmacy. Prescribers and patients must enroll in the program. For further information go to www.XYREM.com or call 1-866-XYREM88®(1-866-997-3688). |
Xyrem is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. Use caution when considering the concurrent use of Xyrem with other CNS depressants. Healthcare providers should caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. Xyrem is a Schedule III controlled substance. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g. assault victim). Monitor patients for emergent or increased depression and suicidality and for impaired motor/cognitive function. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Consider the amount of daily sodium intake in each dose of Xyrem in patients sensitive to salt intake.
This press release contains forward-looking statements, including, but
not limited to, statements related to future events in the Phase 1
clinical program for JZP-386, the timing of the second Phase 1 clinical
trial, the therapeutic potential of JZP-386 and other statements that
are not historical facts. These forward-looking statements are based on
Jazz Pharmaceuticals’ current expectations and inherently involve
significant risks and uncertainties. Actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties,
which include, without limitation, risks and uncertainties associated
with the timing and conduct of clinical trials and the therapeutic value
of JZP-386; the uncertainty of regulatory approval; and those risks with
respect to research and development and clinical trials detailed from
time-to-time under the caption “Risk Factors” and elsewhere in
Concert Pharmaceuticals Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about the future clinical
development of JZP-386, the potential effectiveness of JZP-386, our
plans and timelines for the clinical development of JZP-386 and other
statements containing the words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “would,” and similar
expressions, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical trials
and the results of such trials, whether preliminary results from a
clinical trial will be predictive of the final results of that trial or
whether results of early clinical trials will be indicative of the
results of later clinical trials, expectations for regulatory approvals
and other factors discussed in the " Risk Factors" section of our most
recent Quarterly Report on Form 10-Q filed with the
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Source:
Jazz Pharmaceuticals plc
(investors)
Katherine
Littrell, PhD, RN, U.S. + 650-496-2717
Ireland + 353 1 634 7887
investorinfo@jazzpharma.com
or
(media)
Laurie
Hurley, U.S. + 1-650-496-2796
Ireland + 353 1 634 7894
or
Concert
Pharmaceuticals
(investors)
Justine Koenigsberg, U.S. +
781-674-5284
ir@concertpharma.com
or
(media)
The
Yates Network
Kathryn Morris, U.S. + 845-635-9828