FDA Lifts Clinical Hold, Tanezumab Trial to be Resumed

Pfizer and Eli Lilly and Company announced that they are preparing to resume the Phase 3 clinical pain program for tanezumab. 

This decision was made after the Food and Drug Administration (FDA) agreed to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015. 

RELATED: Impact of Hydrocodone Combination Product Rescheduling on Pain Patients

In the previous clinical studies, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medications. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed. 

Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), by selectively binding to NGF. This inhibits the protein from activating pain-signaling neurons.

 For more information visit Pfizer.com or Lilly.com.

Loading links....