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.

Depomed announces SPA agreement with FDA for Serada Phase 3 trial for menopausal hot flashes

Depomed, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design and analysis of Breeze 3, a Phase 3 trial evaluating Serada® (extended release gabapentin tablets) for menopausal hot flashes.

11 Aug 2010

Epilepsy drugs analyzed for causing increased risk of suicide in patients

While the Food and Drug Administration requires a warning of an increased risk of suicide for all epilepsy drugs, a new study shows that only certain drugs may increase the risk. The study is published in the July 27, 2010, issue of Neurology, the medical journal of the American Academy of Neurology. Newer drugs with a higher risk of causing depression than other epilepsy drugs, such as levetiracetam, topiramate and vigabatrin, were found to increase the risk of self-harm or suicidal behavior among people with epilepsy.

27 Jul 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

Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

New long term data showed that Vimpat- (lacosamide) C-V provided sustained reduction in seizure frequency for up to five years when used as an add-on treatment for uncontrolled partial onset seizures in adults with epilepsy. In addition post-hoc exploratory analyses showed that adjunctive lacosamide treatment reduced partial-onset seizure frequency and improved responder rates when added to a broad range of antiepileptic drugs (AEDs) including both traditional sodium channel-blocking agents and those that act on non-sodium channel-targets.

30 Jun 2010

FDA's acceptance for filing of DM-1796 NDA triggers $10M milestone payment to Depomed

Depomed, Inc. today announced that it has received a $10 million milestone payment from Abbott Products, Inc., its licensee of DM-1796, for the U.S. Food and Drug Administration's acceptance for filing of the New Drug Application (NDA) for DM-1796 for the management of postherpetic neuralgia (PHN), or pain after shingles.

29 Jun 2010

Gabapentin shows effective in patients with locked-in syndrome, opsoclonus-myoclonus syndrome

For patients with quadriplegia, mutism and lower cranial nerve paralysis (locked-in syndrome), their only means of interacting with others is through vertical gaze and upper eyelid movements, using eye-coded communication strategies.

17 Jun 2010

FDA accepts Depomed's DM-1796 NDA for pain after shingles

Depomed, Inc. today announced that the New Drug Application (NDA) for DM-1796 was accepted by the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

8 Jun 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

Mylan subsidiary receives FDA approval for generic version of Neurontin Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Gabapentin Tablets USP, 600 mg and 800 mg, the generic version of Pfizer's Neurontin Tablets for the treatment of postherpetic neuralgia, a complication of shingles.

5 Jun 2010

Depomed attributes 56% increase in first-quarter revenue to $5.8M increase in Glumetza product sales

Depomed, Inc. today reported financial results for the first quarter ended March 31, 2010.

30 Apr 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 licensee submits DM-1796 NDA for management of PHN

Depomed, Inc. today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

31 Mar 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

PROMETA Treatment Program rapidly reduces cravings for methamphetamine subjects: Study

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 methamphetamine dependent subjects were published in the Journal of Psychopharmacology, a peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology.

11 Feb 2010

Depomed expands patent portfolio around extended release gabapentin formulation technology

Depomed, Inc. announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a U.S. patent application (No. 12/239,591) directed to pharmaceutical dosage forms that deliver the compound gabapentin via Depomed’s proprietary Acuform® gastric retentive drug delivery technology.

2 Feb 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Depomed, Inc. announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes.

20 Jan 2010

Antiepileptic drugs may have a possible protective effect against seizure disorders

Despite government warnings about an increased risk of suicidal thoughts and actions while taking antiepileptic drugs, these medications do not appear to be associated with increased risk of suicide attempts in individuals with bipolar disorder, and may have a possible protective effect, according to a report in the December issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

8 Dec 2009