Skip to main content

FDA Asks Experts If Pain Drugs Should Get Second Chance


By Anna Yukhananov
WASHINGTON (Reuters) Mar 09 - U.S. drug regulators are asking experts for advice on whether companies should restart clinical trials for painkillers that help people with osteoarthritis and other conditions, but can destroy joints.
In a memo posted online Thursday The U.S. Food and Drug Administration said these drugs, from the class of anti-nerve growth factors, "represent a potentially significant and novel strategy for the treatment of pain."
Nerve growth factor (NGF) is associated with nerve pain, but it may also help with wound repair and angiogenesis, the FDA said. The joint problems with the drug may be because it blocks these beneficial effects of NFG, one FDA reviewer said.
In 2010, the FDA halted almost all clinical trials of NGF inhibitors after nearly 500 people taking the drugs in studies needed joint replacement.
Companies were allowed to keep testing the drugs in terminal cancer patients with severe bone pain, since the benefits there may outweigh risks.
Pfizer Inc, Regeneron Pharmaceuticals Inc and Johnson & Johnson are now pitching to resume wider trials, in what could be a multi-billion-dollar pain market.
Outside advisers to the FDA will vote Monday on whether there is a way for trials to move forward, perhaps by limiting the drugs to lower doses, or to only certain conditions with fewer treatment options.
The drugs have been studied for common conditions like low back pain and osteoarthritis. They have also been tested in narrower groups, like people with bladder pain syndrome.
Pfizer was furthest along in development of its biotech anti-NGF drug tanezumab when the FDA asked it to halt trials in June 2010. Pfizer had already reported positive data for the medicine.
"We've had strong results from the clinical program. That's why we're so interested in progressing these compounds forward," Pfizer said in an interview on the advisory meeting. "They have the promise of offering chronic pain patients something they haven't had in the past."
The anti-NGF drugs have the potential to become the first biotechnology drugs specifically for pain.
Several injectable biotechnology medicines are used to treat rheumatoid arthritis. More traditional oral pain killers, such as aspirin, ibuprofen and Pfizer's own Celebrex, are typically used to treat osteoarthritis, but may have side effects such as promoting bleeding.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

CareFusion Issues Update on Infant Breathing Product Recall

July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its Air Life ™ Infant Breathing Circuit, initiated back in May. The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units. The update was posted July 2 on the FDA  Website. On May 29, 2012, CareFusion sent an  Urgent Recall Notice  to customers and distributors stating that the company had identified potential risks associated with the Air Life  Infant Breathing Circuit. The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing cracks during patient use. "If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volum...
Post a Comment
Read more

FDA Approves Tapentadol ER for Diabetic Neuropathy

August 29, 2012 — The US Food and Drug Administration (FDA) has approved tapentadol extended-release (ER) ( Nucynta , Janssen Pharmaceuticals, Inc) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults for whom a continuous opioid analgesic is required over an extended time. It is the first opioid to receive this indication, the company notes in a statement today. DPN, the most common type of neuropathy, affects an estimated 16% of the more than 25 million Americans who have diabetes. The condition is often unreported and untreated, with an estimated 2 out of 5 cases not receiving care. Tapentadol ER is already approved for the treatment of moderate to severe chronic pain in adults requiring a continuous opioid analgesic for an extended period. It is a centrally acting synthetic analgesic, although the exact mechanism of action is unknown, the release states. "Although the clinical relevance is unclear," the company n...
4 comments
Read more