K K Jain MD (Dr. Jain is a consultant in neurology and has no relevant financial relationships to disclose.)
Originally released December 30, 2005; last updated September 29, 2020; expires September 29, 2023

Historical note and terminology

Pregabalin is chemically related to the antiepileptic drug gabapentin and is a successor to it for management of neuropathic pain as well as an adjunct therapy for the management of partial onset seizures. Gabapentin, a GABA receptor agonist, is an approved as add-on therapy for intractable partial seizures in adults. Clinical trials of pregabalin started in 2000. It was approved by the FDA for treating diabetic neuropathy and postherpetic neuralgia in 2004 and for fibromyalgia in 2007.

In 2005 the Drug Enforcement Administration placed pregabalin into Schedule V of the Controlled Substances Act. Because of this rule, the regulatory controls and criminal sanctions of Schedule V will be applicable to the manufacture, distribution, dispensing, importation and exportation of pregabalin and products containing pregabalin. In 2012, the manufacturer paid a settlement for misleading promotion of the drug for off-label indications.

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