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American Pain Society releases new post-surgical pain management guideline

The American Pain Society has released a new evidence-based clinical practice guideline, appearing in The Journal of Pain, with 32 recommendations to help clinicians achieve optimal pain management following surgery. According to numerous studies, the majority of surgical patients receive inadequate pain relief, which can heighten the risk for prolonged post-surgical pain, mood disorders and physical impairment.

18 Feb 2016

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

XenoPort's Arbaclofen placarbil fails to meet co-primary endpoints in Phase 3 clinical trial

XenoPort, Inc. announced today top-line results from its pivotal Phase 3 clinical trial of arbaclofen placarbil for the treatment of patients with spasticity due to multiple sclerosis.

20 May 2013

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

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

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