Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update
Phase 1 Results Support Further Evaluation of JZP-386
DUBLIN &
Clinical data from this Phase 1 study demonstrated that JZP-386 provided favorable deuterium-related effects, including higher serum concentrations and correspondingly increased PD effects at clinically relevant time points compared to Xyrem® (sodium oxybate) oral solution. The safety profile of JZP-386 was similar to that observed with Xyrem. While the companies have determined that the deuterium-related effects observed in the Phase 1 studies do not support advancing into a later-stage clinical trial of JZP-386 at this time, the results indicate that further evaluation of JZP-386 is warranted. Accordingly, the companies intend to explore formulation options to enhance the positive effects observed in the studies to achieve an improved product profile for patients with narcolepsy.
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
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IMPORTANT SAFETY INFORMATION |
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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.
In three controlled clinical trials, the most common adverse reactions (incidence ≥5% and twice the rate of placebo) in Xyrem-treated patients were nausea (20%), dizziness (15%), vomiting (11%), somnolence (8%), enuresis (7%), and tremor (5%).
Please click here to see the full Prescribing Information for Xyrem, including BOXED Warning.
This press release contains forward-looking statements, including, but
not limited to, statements related to future evaluation of JZP-386 and
exploration of formulation options to achieve an improved product
profile for patients, 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
therapeutic potential of JZP-386 and the outcome of further evaluation
and exploration of JZP-386; 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 evaluation 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
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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 (media), U.S. + 845-635-9828