The development of Anti-NGF (anti-nerve growth factor) class of drugs should go ahead, the Arthritis Advisory Committee has told the FDA. The Committee is an advisory body that recommends what the FDA (Food and Drug Administration) should do. Although the FDA is not bound by the Committee’s recommendations, it nearly always tends to go along with their opinions.
Anti-NGFs are currently being developed for several chronic painful conditions, including lower back pain, cancer pain, thermal injury, vertebral fracture, diabetic peripheral neuropathy, post-herpetic neuralgia, endometriosis, chronic pancreatitis, and interstitial cystitis.
The Committee was asked to discuss reports of joint destruction associated with Anti-NGF class of drugs that are currently being developed, and some other safety issues, and whether the potential adverse events are outweighed by their benefits.
The 21-member panel, consisting of arthritis experts, all voted in favor of a continuation the development of nerve-blocking medications, as long as certain safety precautions were observed.
In 2010, reports of articulation (joint) problems led to the FDA halting studies on these types of drugs. Three Anti-NGF research and development companies, Regeneron Pharmaceuticals, Pfizer Inc., and Johnson & Johnson asked the FDA to reconsider the ban on the testing of such drugs.
Most arthritis and chronic pain experts agree that the safety issue is important, but stress that pain management has needs which must urgently be addressed. A considerable number of patients do not respond adequately to current pain medications, such as aspirin or Aleve.
Regeneron Pharmaceuticals, Pfizer Inc., and Johnson & Johnson say that Anti-NGFs are probably breakthroughs in pain management for patients with chronic pain, such as back pain and osteoarthritis. Early testing has produced promising and strong results. Anti-NGFs have certain advantages over opiates, for example, they do not carry the high addiction risk.
Anti-NGF medications block proteins that control the body’s sensation of pain. In a number of patients, anti-NGFs worsened their arthritis – some even experienced total joint failure. Maybe the drug’s success is partly to blame; if there is less pain there is more physical activity, which raises the risk of damage, especially if the patient with chronic pain already has joint problems.
The Arthritis Advisory Committee Meeting stressed that anti-NGFs should not be taken with older drugs in subsequent trials. Clinical trial participants should be told of the known risks and made to sign an informed consent waiver. Throughout the studies, participants should undergo regular imaging scans to check their bones.
Written by Chrisitan Nordqvist