Gabapentin Enacarbil News and Research

RSS

XenoPort initiates XP23829 Phase 2 clinical trial in patients with psoriasis

XenoPort, Inc. announced today that it has initiated a Phase 2 clinical trial of XP23829, its proprietary investigational next-generation fumaric acid product candidate. The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of XP23829 as a potential treatment of patients with moderate-to-severe chronic plaque-type psoriasis.

23 Jun 2014

XenoPort reports net loss of $19.1 million for fourth quarter 2013

XenoPort, Inc. announced today its financial results for the fourth quarter and year ended December 31, 2013. Revenues for the fourth quarter were $2.9 million, compared to $0.5 million for the same period in 2012. Net loss for the fourth quarter was $19.1 million compared to net income of $3.0 million that resulted from a non-cash gain from XenoPort's litigation settlement with Glaxo Group Limited in the fourth quarter of 2012. At December 31, 2013, XenoPort had cash and cash equivalents and short-term investments of $58.7 million.

20 Feb 2014

FDA-approved drug pregabalin effectively treats RLS symptoms with less side effects

A report in the Feb. 13 New England Journal of Medicine confirms previous studies suggesting that long-term treatment with the type of drugs commonly prescribed to treat restless leg syndrome (RLS) can cause a serious worsening of the condition in some patients.

14 Feb 2014

Restless legs syndrome and insomnia: a possible explanation

Johns Hopkins researchers believe they may have discovered an explanation for the sleepless nights associated with restless legs syndrome (RLS), a symptom that persists even when the disruptive, overwhelming nocturnal urge to move the legs is treated successfully with medication.

7 May 2013

Regnite to treat primary restless legs syndrome launched in Japan

Astellas Pharma Inc. and XenoPort, Inc. announced today that Regnite (gabapentin enacarbil) Extended-Release Tablets will be launched in Japan on July 10, 2012. Regnite is approved in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

9 Jul 2012

FDA approves XenoPort, GSK’s Horizant ER tablets for management of PHN

GlaxoSmithKline plc (GSK) and XenoPort, Inc. announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.

7 Jun 2012

XenoPort first quarter revenues increase to $10.4 million

XenoPort, Inc. announced today its financial results for the first quarter ended March 31, 2012. Revenues for the quarter were $10.4 million, compared to $0.4 million for the same period in 2011.

3 May 2012

GlaxoSmithKline, XenoPort receive FDA approval for Horizant to treat RLS

On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets, a once-daily treatment for moderate-to-severe restless legs syndrome.

8 Apr 2011

FDA approves Horizant Extended-Release Tablets for Restless Legs Syndrome

GlaxoSmithKline and XenoPort, Inc. announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night.

7 Apr 2011

XenoPort third quarter net loss decreases to $19.9 million

XenoPort, Inc. announced today financial results for the third quarter and nine months ended September 30, 2010. Revenues for the third quarter were $0.4 million, compared to $0.4 million for the same period in 2009. Net loss for the third quarter was $19.9 million, compared to a net loss of $24.4 million for the same period in 2009.

8 Nov 2010

FDA reviews GSK's response to Complete Response letter for Horizant

GlaxoSmithKline and XenoPort, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review GSK's response to FDA's Complete Response letter for Horizant (gabapentin enacarbil) Extended-Release Tablets. Horizant is under review for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

8 Nov 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

Clinical trial data of XP19986, XP13512 to be presented at Associated Professional Sleep Society meeting

XenoPort announced today that data from clinical trials of its product candidates arbaclofen placarbil and XP13512 (gabapentin enacarbil) will be presented at the Associated Professional Sleep Society meeting in San Antonio, Texas.

7 Jun 2010

European patent for XenoPort's investigational compound is valid

XenoPort, Inc. announced today that the European Patent Office (EPO) Opposition Division ruled that the European patent for the composition of matter of XP13512 (European Patent No. 1 404 324) is valid.

16 Apr 2010

XenoPort to present arbaclofen placarbil, XP13512 trial data at 62nd American Academy of Neurology meeting

XenoPort announced today that new data from clinical trials of its product candidates arbaclofen placarbil and XP13512 (gabapentin enacarbil) will be presented at the 62nd Annual American Academy of Neurology meeting in Toronto, Ontario.

12 Apr 2010

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Depomed, Inc. today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets.

19 Feb 2010

FDA issues Complete Response Letter for Horizant in treatment of RLS

GlaxoSmithKline and XenoPort, Inc. Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

18 Feb 2010

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

19 Nov 2009

FDA extends review date of New Drug Application for GSK1838262/XP13512

GlaxoSmithKline and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.

7 Nov 2009

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

GlaxoSmithKline and XenoPort, Inc. today announced top-line results from a Phase II clinical trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher.

5 Oct 2009