Pfizer Restricts Use of Pregabalin for Some Clinical Trial Patients
Pfizer
(PFE) - Get Pfizer Inc. Report
has restricted the use of pregabalin for certain patients in clinical trials after the results from a study with mice found an increased incidence of a specific tumor type.
The restriction, which follows discussions with the
Food and Drug Administration
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, comes after the agency's analysis of previously submitted results from the mouse study. The company doesn't know whether the results are applicable to humans. A similar dosing study in rats didn't show increases in any tumor type, and the results weren't seen in any other toxological screen or study.
Pregabalin is being developed for treating neuropathic pain, epilepsy, a variety of anxiety disorders and chronic pain conditions. Pfizer plans to proceed with the submission of a new drug application for the product, which would cover pregabalin's uses for treating neuropathic pain and epilepsy.
Shares of Pfizer gained $1.08, or 2.4%, to end the
New York Stock Exchange
regular session at $46.12.
