Gabapentin News and Research

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Gabapentin (brand name Neurontin) is a medication originally developed for the treatment of epilepsy. Presently, gabapentin is widely used to relieve pain, especially neuropathic pain.

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

EpiCept announces third quarter 2009 financial results

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2009, and provided an update on Ceplene® and several of the Company’s key product candidates.

10 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

Brain researcher finds how the epilepsy and pain drug works

A Duke University Medical Center researcher who spent years looking for the signals that prompt the brain to form new connections between neurons has found one that may explain precisely how a well-known drug for epilepsy and pain actually works.

14 Oct 2009

Depomed announces results from BREEZE 1 and 2 Phase 3 clinical trials of Serada

Depomed, Inc. announced today top-line results from the BREEZE 1 and 2 Phase 3 clinical trials evaluating the safety and efficacy of SeradaTM, an investigational non-hormonal extended release formulation of gabapentin for the treatment of menopausal hot flashes.

12 Oct 2009

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

Depomed, Inc. today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA.

5 Oct 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

New drug combination releives neuropathic pain and improves sleep

People who suffer from debilitating neuropathic pain may get more relief and sleep better by combining two commonly-prescribed drugs.

1 Oct 2009

Journal publishes Hythiam's PROMETA treatment program results

Hythiam, Inc. announced today that the results of a double-blind, placebo-controlled study on the impact of the medical component of the PROMETA® Treatment Program on alcohol dependent subjects was accepted and published in the Journal of Clinical Psychopharmacology, a leading scholarly publication in psychopharmacology that features articles reporting on clinical trials and studies.

29 Sep 2009

Results from Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 announced

GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) today announced top-line results from a Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.

17 Sep 2009

Gabapentin improves sleep quality in menopausal women

Gabapentin, a drug initially used to treat seizures, improves sleep quality in menopausal women with hot flashes, University of Rochester Medical Center researchers report online and in the September issue of the Journal of Women's Health.

9 Sep 2009

Compound from coral offers hope fpr neuropathic pain

A compound initially isolated from a soft coral (Capnella imbricata) collected at Green Island off Taiwan, could lead scientists to develop a new set of treatments for neuropathic pain - chronic pain that sometimes follows damage to the nervous system.

4 Aug 2009

Pregabalin shows potential as treatment for hot flashes

A pill used for nerve pain offers women relief from hot flashes, Mayo Clinic researchers report at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).

17 May 2009

Oxycodone effective against shingles pain

The painkiller oxycodone is effective at treating the acute pain of shingles, an illness that often causes severe pain which can become long-lasting and sometimes even permanent.

26 Mar 2009

GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

12 Jan 2009

FDA requires stronger warnings on antiepileptic medicines

The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

16 Dec 2008

KAI Pharmaceuticals reports positive results for KAI-1678 in pain reduction

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced preclinical results demonstrating the effectiveness of KAI-1678 in reversing pain (hyperalgesia and allodynia) in multiple preclinical models.

19 Nov 2008

GlaxoSmithKline and XenoPort submit NDA for Solzira for restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

16 Sep 2008

FDA warns consumers about Baltimore Medicine Shoppe pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit.

10 Aug 2008

Epilepsy drug gabapentin may reduce insomnia in recovering alcoholics

It's a Catch-22 of the highest order. People with alcohol problems often use alcohol to get to sleep -- but it actually keeps them from getting good-quality sleep all night long.

4 Aug 2008