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From the Wires
Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fibromyalgia
By: PR Newswire
Nov. 20, 2008 04:01 PM
PRELIMINARY TOP LINE RESULTS OF FIRST PHASE III TRIAL SHOW SIGNIFICANT
DECREASES IN PAIN AND FATIGUE, AND IMPROVEMENT IN DAILY FUNCTION, IN
FIBROMYALGIA PATIENTS
"There is a significant unmet need in diagnosing and treating millions of
patients with fibromyalgia. Potential new treatments that address the various
symptoms can have a significant impact on patients' quality of life," said The 14-week study included 548 adult patients with fibromyalgia randomized to one of three treatment arms: sodium oxybate 4.5 g/night, sodium oxybate 6 g/night or placebo. The primary outcome measure, viewed by both U.S. and EU regulatory authorities as a clinically meaningful endpoint, was the proportion of patients who achieved at least 30 percent reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS). In the EU it is also considered that Fibromyalgia Impact Questionnaire (FIQ) data is equally relevant. FIQ data are considered supportive data by U.S. regulators. In the top-line results, a significant number of patients treated with sodium oxybate achieved 30 percent or greater improvement in their pain compared to patients treated with placebo. Of those patients receiving sodium oxybate treatment, 46.2 percent of patients on 4.5 g/night and 39.3 percent of patients on 6 g/night reported this level of pain relief, compared with 27.3 percent of patients on placebo. These results were highly statistically significant. Patients' physical functioning and ability to perform daily tasks, as measured by the FIQ, were significantly different from placebo for the 4.5 g/night dose and approached significance for the 6 g/night dose. Patients receiving sodium oxybate also reported significant improvement in fatigue, another common symptom of fibromyalgia, at both active dosage levels. Adverse events were similar to those seen in previous experience with sodium oxybate. The most common adverse events, with incidence greater than or equal to 5 percent and at least twice the rate of placebo, were headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature. "Achieving positive sodium oxybate (JZP-6) data in fibromyalgia from this
Phase III clinical trial is an exciting milestone for Jazz Pharmaceuticals,
and supports our commitment to developing products that can improve outcomes
for patients with serious medical conditions," said "As UCB continues to focus on serious diseases of the central nervous system and immunology, we are delighted to partner with Jazz Pharmaceuticals in bringing new hope for patients with this under-treated condition," said Roch Doliveux, Chief Executive Officer of UCB. Only primary efficacy and safety data have been reviewed at this time.
Further analyses will be undertaken to examine the full results, including
secondary endpoints, in greater detail. The sodium oxybate Phase III clinical
trial program also includes a second randomized, double blind,
placebo-controlled study, which is continuing at sites in the U.S. and Jazz Pharmaceuticals will host an investor conference call and live audio
webcast to discuss the preliminary top-line results from this clinical trial
on About Sodium Oxybate Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA for the treatment of excessive daytime sleepiness (EDS) and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the U.S. Food and Drug Administration-approved indications. It is also approved by the European Medical Evaluation Agency (EMEA) for the treatment of narcolepsy with cataplexy in adult patients. Most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use. About Fibromyalgia Fibromyalgia, a chronic condition characterized by widespread pain, affects 0.5% - 5% of adults worldwide. Fibromyalgia is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes of fibromyalgia are unknown. It may be triggered by physical trauma, emotional stress, chronic pain or infection. Genetics, neurochemicals that affect pain modulation, neurohormones and sleep physiology abnormalities are thought to play a role. Research also has suggested a relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleep problems, including a reduction in non-restorative or deep sleep. About Jazz Pharmaceuticals, Inc. Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. The Company has an unwavering commitment to improving care for patients with serious psychiatric and neurological conditions through innovative treatments and distinctive and valuable programs for patients and physicians. For further information see http://www.JazzPharmaceuticals.com. About UCB UCB ( Jazz Pharmaceuticals "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements related to the
development of Jazz Pharmaceuticals' sodium oxybate (JZP-6) product candidate
for the treatment of fibromyalgia, including the submission of a New Drug
Application to the FDA. These forward-looking statements are based on the
company's current expectations and inherently involve significant risks and
uncertainties. Jazz Pharmaceuticals' 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, the risk that clinical trial results may require Jazz
Pharmaceuticals to discontinue development of the sodium oxybate (JZP-6)
product candidate, risks related to Jazz Pharmaceuticals' ability to obtain
additional funds sufficient to support its operations, risks related to Jazz
Pharmaceuticals' reliance on third parties to conduct the clinical trials for
its product candidates, including the second Phase III clinical trial of the
sodium oxybate (JZP-6) product candidate, and risks that regulatory filings
may not be made, or may be delayed, and that the sodium oxybate (JZP-6)
product candidate for the treatment of fibromyalgia may not be approved for
marketing by regulatory authorities. These and other risk factors are
discussed under "Risk Factors" in the Quarterly Report on Form 10-Q for the
quarter ended UCB Forward-looking Statement This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of employees. SOURCE Jazz Pharmaceuticals, Inc. Latest Cloud Developer Stories
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