Jazz Pharmaceuticals To Present Data On Compound In Sleep Pipeline During APSS Annual SLEEP Meeting
The abstract titled "Efficacy and Safety of Oral ADX-N05 for the Treatment of Excessive Daytime Sleepiness in Adults with Narcolepsy: Results of a Randomized, Double-Blind, Placebo-Controlled Trial" will be presented during the Late-breaking Abstracts oral presentation session on
Company management will host a live audio webcast following the presentation at
Audio webcast/conference call:
U.S. Dial-In Number: +1 866 515 2912
International Dial-In Number: +1 617 399 5126
Passcode: 56517063
A replay of the conference call will be available through
Replay U.S. Dial-In Number: +1 888 286 8010
Replay International Dial-In Number: +1 617 801 6888
Passcode: 79173542
"As a company dedicated to improving the lives of people with severe sleep disorders, we look forward to presenting the JZP-110 Phase 2b data to the sleep community," said
Full details of the APSS annual meeting can be found here: http://www.aasmnet.org/resources/flipping/sleep2014finalprogram/
Jazz Pharmaceuticals Clinical Development Pipeline in Narcolepsy and Sleep
- Xyrem® (sodium oxybate) oral solution in Children and Adolescents: In working with the
Food and Drug Administration (FDA ),Jazz Pharmaceuticals has received a Pediatric Written Request from theFDA to study Xyrem in children and adolescents. The company is preparing to conduct a Phase 3 clinical trial to assess the safety and efficacy of sodium oxybate in children and adolescents aged seven to 17 years who have narcolepsy with cataplexy. The company plans to initiate clinical sites for this study in the second half of 2014. - JZP-110:
Jazz Pharmaceuticals is currently planning a Phase 3 clinical development program for this investigational compound for the treatment ofEDS in adults with narcolepsy and for the treatment ofEDS in adults with obstructive sleep apnea. - JZP-386: Pre-clinical trials are underway with a deuterium-modified analog of sodium oxybate.
Jazz Pharmaceuticals expects the first-in-human study to begin inEurope in 2014, subject to availability of clinical trial material.
About Xyrem
Xyrem® (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness (
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.
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.
About Jazz Pharmaceuticals plc
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to
SOURCE
Jazz Pharmaceuticals: Investors: Kathee Littrell, Vice President, Investor Relations, Ireland, +353 1 634 7887, U.S., +1 650 496 2717, or Media: Laurie Hurley, Vice President, Corporate Affairs, Ireland, +353 1 634 7894, U.S., +1 650 496 2796