Pfizer Inc. is attempting to acquire U.S. Food and Drug Administration (FDA) approval for Pregabalin, a pain medication designed to treat disorders of the central nervous system (CNS). By the end of 2000, Pfizer was set to file an application with the FDA for the approval of Pregabalin for such conditions as anxiety, neuropathic pain, epilepsy, social phobia and fibromyalgia. Unfortunately in February 2001, after receiving alarming reports that mice that were given Pregabalin developed tumors, Pfizer restricted further studies for most clinical trial patients.
In 2002 and 2003, however, Pfizer again initiated clinical trials. In October 2002, researchers found that Pregabalin use improved pain and fatigue symptoms in patients with fibromyalgia and in March 2003, clinical trials confirmed that the drug is safe for treating generalized anxiety disorder. Pfizer hopes to file an application for Pregabalin approval for pain and anxiety by the end of 2003.
See Also
- Painkillers: Overview