PharmaSentry :: Lyrica

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Lyrica

Developer:	Pfizer Inc.
Chemical Name:	Pregabalin
Drug Class (Type):	Alpha 2 delta Ligand (Chemical)
Dose Form:	Capsule
Indication:	Lyrica is indicated as adjunctive therapy for adult patients with partial onset seizures.
Disease/Medical Usage:	Partial onset seizures
Therapeutic Category:	Anticonvulsants
Status:	Approved As of Sep 21, 2005, Lyrica was launched in the United States for the adjunctive treatment of partial onset seizures in adults with epilepsy.As of Jun 13, 2005, Lyrica was approved in the United States for the adjunctive treatment of partial onset seizures in adults with epilepsy.As of Nov 30, 2004, Lyrica was awaiting approval in the United States as adjunctive therapy for partial seizures in patients with epilepsy.As of Jul 6, 2004, Lyrica was awaiting approval in the United States as adjunctive therapy for partial seizures in patients with epilepsy.As of Jan 22, 2004, Pregabalin was awaiting approval in the United States as adjunctive therapy for partial seizures in patients with epilepsy.As of Oct 31, 2003, Pregabalin was awaiting approval in the United States as adjunctive therapy for partial seizures in patients with epilepsy. As of Jun 23, 2003, Pregabalin was in Phase III clinical trials in the United States for the treatment of epilepsy.As of May 1, 2003, Pregabalin was in Phase III clinical trials in the United States as adjunctive therapy in the treatment of epilepsy.On Sep 6, 2002, Pfizer Inc. announced that it has determined that it will not submit an application with the Food and Drug Administration relating to pregabalin prior to year-end 2002. Company expects to submit an application in Europe in March 2003 and subsequently in the U.S. The application will seek approval for use in add-on epilepsy, neuropathic pain and generalized anxiety disorders.As of June 27, 2002, Pregabalin was in Phase III clinical trials in the United States for the treatment of epilepsy.On Apr 17, 2002, Pfizer Inc. announced that it anticipates completing regulatory filings in 2002 for use of pregabalin in neuropathic pain, epilepsy, and generalized anxiety disorder.On Feb 1, 2002, Pfizer announced that it anticipates completing regulatory filings in 2002 for use of pregabalin in neuropathic pain, epilepsy, and generalized anxiety disorder.On Dec 19, 2001, Pfizer Inc. announced that it will delay filing applications for several new medications, including Pregabalin for epilepsy, chronic nerve pain, and generalized anxiety disorder, with the Food and Drug Administration in order to bolster data that the company hopes will lead to speedier approvals in the long run. Pfizer would seek approval for all three uses of the medicine sometime next year.As of May 22, 2001, Prgabalin was in Phase III clinical trials in the United States to treat epilepsy.On Feb. 12, 2001, Pfizer Inc. said that it has restricted the use of pregabalin for certain patients in clinical trials following discussions with the U.S. Food and Drug Administration.The restriction follows the FDA's analysis of previously submitted results from a lifetime mouse study that showed an increased incidence of a specific tumor type. It is not known whether these results are applicable to humans, since pregabalin is not a chemical mutagen and not genotoxic in pre-clinical studies. A similar lifetime dosing study in rats did not show increases in any tumor type nor were these results seen in any other toxological screen or study.Pregabalin currently is in development for the treatment of neuropathic pain, epilepsy, a variety of anxiety disorders and chronic pain conditions for which there are only limited treatment options.The planned submission of the new drug application for neuropathic pain and epilepsy is expected to proceed as previously announced.On Dec. 11, 2000, Pfizer announced that it anticipates filing pregabalin for seven major indications beginning with neuropathic pain and add-on epilepsy in 2001.As of Dec. 29, 1999, CI-1008 was in Phase III clinical trials in the United States to treat epilepsy.On June 1, 1999, Warner-Lambert was reported to be moving pregablin faster than expected with more potential applications.
Geographic Region:	United States
Total Sales for 2009:	Not Specified
Last Updated:	March 13, 2006