NEW YORK, July 19 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE: PFE) today 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.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
|SOURCE Pfizer Inc.|
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