Pfizer forced to halt pain drug trials

pharmafile | July 20, 2010 | News story | Research and Development Pfizer, chronic pain, pain therapeutics, tanezumab 

Pfizer has been told by the FDA to suspend trials of its novel injectable biotherapeutic tanezumab for chronic low back pain and painful diabetic peripheral neuropathy.

The US regulator’s request follows its consideration of reports of adverse events in osteoarthritis patients taking tanezumab, and concerns regarding the potential for such events in other patient populations in which the compound is being studied.

Pfizer previously halted trials of tanezumab in patients with osteoarthritis on 23 June.

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.

Investigation of the compound will continue in some areas of unmet medical need, including cancer pain and pancreatitis, interstitial cystitis (painful bladder syndrome).

The news will be a blow to the US giant as pain medications were one of its six key ‘Invest to Win’ therapy areas announced in January.

Pfizer already markets Lyrica for neuropathic pain, and last year the drug was its second biggest seller, earning sales of $2.8 billion.

Ben Adams

Related Content

Pfizer’s Velsipity approved by EC for ulcerative colitis treatment

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) …

EC approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma

Pfizer has announced that the European Commission (EC) has granted conditional marketing authorisation for Elrexfio …

CDC Advisory Committee recommends Pfizer’s RSV vaccine

Pfizer has announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee …

Latest content