Pfizer Stops Diabetic Nerve Pain Drug Trials at FDA Request

Shares

Pfizer Inc. announced, at the request of the U.S. Food and Drug Administration (FDA), the suspension of the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain.

The FDA’s request follows further consideration of reports of adverse events in osteoarthritis patients taking tanezumab, and the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied.  Pfizer announced the suspension of tanezumab studies in patients with osteoarthritis in a June 23 press release.

For studies on clinical hold, recruitment of new patients and the dosing of existing patients are suspended.

Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab.

0 0 vote
Article Rating
Subscribe
Notify of
guest
0 Comments
Inline Feedbacks
View all comments
Copyright © 2009-2020 Diabetes Media Foundation, All Rights Reserved.
ASweetLife™ is a trademark of the Diabetes Media Foundation, All Rights Reserved.
DMCA Compliant
0
Would love your thoughts, please comment.x
()
x