Clinical trial of tanezumab for back pain suspended
Published on 20 Jul 2010
A clinical trial involving an experimental drug called
tanezumab for use in patients with chronic low back pain has been suspended amid
safety concerns.
Pharmaceutical company Pfizer
said that the trial - along with a separate one involving patients
with painful diabetic peripheral neuropathy - has been halted on
the request of the US Food and Drug
Administration.
According to Pfizer, the move
"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".
The earlier
osteoarthritis trial was halted in June 2010, after researchers
observed that a small number of patients had experienced a
worsening of their joint
degeneration.
Researchers will not be recruiting
further trial participants for the chronic low back pain trial and
those already taking part will not be given any further doses of
tanezumab.
The drug is a monoclonal antibody
which is designed to treat pain by binding to nerve growth factor
(NGF). This prevents NGF from binding to receptors on nerve cells
so that pain signals are blocked.
A spokesman for
Arthritis Research UK said that the suspension of the trial was
further evidence of the need for new, side-effective-free
painkillers for chronic back pain and osteoarthritis.