XenoPort Announces the Initiation of a Phase 2b Clinical Trial of XP13512 As a Treatment for Restless Legs Syndrome
Posted on: Thursday, 10 February 2005, 09:00 CST
SANTA CLARA, Calif., Feb. 10 /PRNewswire/ -- XenoPort, Inc. announced today the initiation of a Phase 2b clinical trial with XP13512 for the treatment of restless legs syndrome (RLS). The goal of this clinical trial is to assess the efficacy of two different doses of XP13512 administered once a day for 14 days. The Phase 2b clinical trial is a randomized, double-blind, placebo-controlled trial that will be conducted at multiple sites in the United States. XenoPort expects to complete this clinical trial later this year.
"We believe that treatment with XP13512 has the potential to provide meaningful benefit to patients suffering from restless legs syndrome," commented Pierre Tran, M.D., XenoPort's chief medical officer. "We were very encouraged by the efficacy of XP13512 observed in the Phase 2a trial that we recently completed, and we look forward to the results of this Phase 2b trial evaluating additional doses of XP13512 given once-daily. Upon successful completion of this clinical trial, we expect to initiate Phase 3 clinical trials that will be required for regulatory approval of XP13512 as a treatment for RLS."
About Restless Legs Syndrome (RLS)
Restless legs syndrome is a common, under-diagnosed neurological disorder that frequently manifests itself as a sleep disorder. Patients who suffer from RLS experience an irresistible urge to move their legs. This urge is usually accompanied by unpleasant sensations of burning, creeping, tugging or tingling inside the patients' legs, ranging in severity from uncomfortable to painful. These RLS-related symptoms typically begin or worsen during periods of rest or inactivity, particularly when lying down or sitting, and may be temporarily relieved by movement such as walking or massaging the legs. Symptoms often worsen at night, and disturbed sleep is a common result of RLS. Left untreated, RLS may cause exhaustion, daytime fatigue, inability to concentrate and impaired memory. According to the National Institute of Neurological Disorders and Stroke, RLS is the third largest sleep disorder, after insomnia and sleep apnea. Although the exact prevalence rate of RLS is uncertain, a recent study has indicated that approximately 10% of patients visiting primary care physicians in the United States and four European countries experience RLS symptoms at least weekly, with approximately 2% of patients visiting primary care physicians suffering from symptoms severe enough to disrupt their quality of life. There are no drugs currently approved by the U.S. Food and Drug Administration for the treatment of RLS.
About XP13512
XP13512 is a Transported Prodrug(TM) of gabapentin, a drug that has been sold by Pfizer Inc as Neurontin(R) since 1993 and is currently sold as a generic drug by a number of companies. XP13512 is designed to be actively transported from the GI tract into the bloodstream, where it is metabolized to produce gabapentin. Besides gabapentin, the metabolic breakdown products of XP13512 are substances with well-studied, favorable safety characteristics. Phase 1 clinical trials in healthy volunteers have demonstrated that, in contrast to Neurontin, oral administration of XP13512 produces dose-proportional blood levels of gabapentin across a broad range of doses. Additional Phase 1 clinical trials with a sustained-release formulation of XP13512 demonstrated that, compared to equivalent doses of Neurontin, XP13512 produced higher levels of gabapentin in the blood for a longer period of time. XP13512 was well tolerated in all Phase 1 clinical trials. In a Phase 2a clinical trial, XP13512 was shown to be effective in treating RLS. In addition to RLS, XP13512 is currently being evaluated in a Phase 2a clinical trial for the management of post-herpetic neuralgia.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transporter mechanisms to improve the therapeutic benefits of existing drugs. Our most advanced product candidate, XP13512, is currently being evaluated in this Phase 2b clinical trial for the treatment of restless legs syndrome and in a Phase 2a clinical trial for the management of post-herpetic neuralgia.
XenoPort, Inc.
CONTACT: Ellen M. Martin of Kureczka/Martin Associates, +1-510-832-2044,or emm4@pacbell.net, for XenoPort, Inc.
Source: PRNewswire
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