The 2004 settlement was one of the largest in U.S. history, and the first off-label promotion case brought successfully under the False Claims Act. Brand names
Gabapentin was originally marketed under the brand name Neurontin. Since it became generic, it has been marketed worldwide using over 300 different brand names. An extended-release formulation of gabapentin for once-daily administration was introduced in 2011, for postherpetic neuralgia under the brand name Gralise. Related drugs
Parke-Davis developed a drug called pregabalin, which is related in structure to gabapentin, as a successor to gabapentin. Another similar drug atagabalin has been unsuccessfully tried by Pfizer as a treatment for insomnia. A prodrug form (gabapentin enacarbil) was approved by the U.S. Food and Drug Administration (FDA). Recreational use
Gabapentin when taken in excess can induce euphoria, a sense of calm, a marijuana-like high, improved sociability, and reduced alcohol or cocaine cravings. Also known on the streets as "Gabbies", gabapentin is increasingly being abused and misused for these euphoric effects. About 1 percent of the responders to an internet poll and 22 percent of those attending addiction facilities had a history of abuse of gabapentin. Gabapentin misuse, toxicity, and use in suicide attempts among adults in the US increased from 2013 to 2017.After Kentuckys implementation of stricter legislation regarding opioid prescriptions in 2012, there was an increase in gabapentin-only and multi-drug use in 2012–2015. The majority of these cases were from overdose in suspected suicide attempts.
History
Gabapentin was designed by researchers at Parke-Davis to be an analogue of the neurotransmitter GABA that could more easily cross the blood–brain barrier and was first described in 1975 by Satzinger and Hartenstein. Under the brand name Neurontin, it was first approved in May 1993, for the treatment of epilepsy in the United Kingdom. Approval by the U.S. Food and Drug Administration followed in December 1993, for use as an adjuvant (effective when added to other antiseizure drugs) medication to control partial seizures in adults; that indication was extended to children in 2000. Subsequently, gabapentin was approved in the United States for the treatment of postherpetic neuralgia in 2002. A generic version of gabapentin first became available in the United States in 2004. An extended-release formulation of gabapentin for once-daily administration, under the brand name Gralise, was approved in the United States for the treatment postherpetic neuralgia in January 2011. Society and culture
Legal status
United Kingdom
Effective April 2019, the United Kingdom reclassified the drug as a class C controlled substance. United States
Effective 1 July 2017, Kentucky classified gabapentin as a schedule V controlled substance statewide. Effective 9 January 2019, Michigan also classified gabapentin as a schedule V controlled substance. Gabapentin is scheduled V drug in other states such as West Virginia, Tennessee, Alabama. Off-label promotion
Although some small, non-controlled studies in the 1990s—mostly sponsored by gabapentins manufacturer—suggested that treatment for bipolar disorder with gabapentin may be promising, the preponderance of evidence suggests that it is not effective.