A Advisory Panel of the FDA gave the Green Light to Restart NGF Antibody Trials Investigators pleased that promising agents for pain relief have new life, states a new entry in http://www.painresearchforum.org.
Interestingly palmitoylethanolamide with which we work is a natural inhibitor of the effects of NGF!
An advisory panel of the U.S. Food and Drug Administration (FDA) has voted unanimously that antibodies against nerve growth factor (NGF) should re-enter clinical trials for pain. The 21-person Arthritis Advisory Committee made its recommendation to the FDA in a meeting held yesterday at the FDA’s campus in Silver Spring, Maryland, US.
NGF antibodies showed great promise in Phase 3 trials for osteoarthritis, and in Phase 2 testing for other conditions, but have been sitting on the shelf since 2010, when the FDA suspended almost all trials due to reports of unexplained joint damage.
At a recent meeting, the FDA advisors, along with drug makers Pfizer, Janssen Research & Development (part of Johnson & Johnson), and Regeneron, agreed that NGF antibodies are, in fact, associated with joint problems, especially when administered at higher doses and in combination with non-steroidal anti-inflammatory drugs (NSAIDs). They concluded that new restrictions on future trials are needed—but that additional trials are, indeed, warranted.
The Committee evaluated whether NGF antibodies merit continued testing in osteoarthritis and other conditions for which treatments already exist, and separately considered whether the pain relievers deserve study in other, more intractable pain conditions. All panelists agreed on both counts, with the exception of David Blumenthal of Case Western Reserve University and the Cleveland Veterans Affairs Medical Center, US, who voted against the plan to reopen testing beyond the osteoarthritis setting.
Importantly, the antibodies may cause damage even in patients whose joints are not already compromised by osteoarthritis, because some cases of unexpected joint damage cropped up in trials for other ailments and in patients without a known history of osteoarthritis. Blumenthal said that patients with osteoarthritis who are already at risk for joint replacement surgery will make the best study subjects for now.
But only after learning more about how to mitigate joint damage risk should testing continue beyond this group. “I see this as a two-stage process,” he said during the meeting. Indeed, one theme that emerged during the discussion was the dearth of information about treatment-related joint damage, and how to design the next round of NGF antibody testing to fill in the gaps.
Most notably, clinical reviewers who examined cases of serious joint damage in the trials had difficulty pinning specific diagnoses on the incidents, largely because of spotty imaging and pathology data. So committee members discussed monitoring protocols—imaging joints before patients enter a study, for example—that could help researchers discover the mechanisms and risk factors for treatment-induced joint damage.