Fentanyl (Abstral) tablets have been approved by the US Food and Drug Administration (FDA) to help opioid-tolerant adults with cancer manage so-called "breakthrough" pain that occurs suddenly and requires a short-term higher dose of a patient's round-the-clock opioid regimen.
Only doctors skilled in the use of Schedule II opioids should prescribe this product, the FDA said in a news release. Any pharmacy, distributor or health care professional involved in Abstral's distribution or use will have to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program, designed to minimize misuse and abuse, the agency added.
Abstral's safety was evaluated in clinical studies involving 311 opioid-tolerant cancer patients with breakthrough pain. The most common side effects included nausea, constipation, drowsiness and headache.
The FDA warned that the risk of death had been cited in studies of similar immediaterelease fentanyl products. "The deaths occurred as a result of improper patient selection and/or improper dosing," the agency said.
Abstral is produced by ProStraken Inc., based in Bedminster, New Jersey.
Another Pain Medicine
In similar news, Xgeva (denosumab) was approved by the US Food and Drug Administration (FDA) to prevent fractures and other skeletal complications in people with advanced cancer that has metastasized (spread) to the bones.
As many as 75% of people with advanced cancer of the prostate, lung or breast have it spread to the bones, Xgeva's manufacturer, Amgen Inc., said in a news release. This may lead to complications such as debilitating pain, bone fractures and compression of the spinal cord, the drug maker said.
Xgeva, injected once monthly, targets a cancer-related protein that destroys bone cells, the FDA said in a news release. The drug's safety and effectiveness were evaluated in clinical studies involving 5,723 people. The trials showed Xgeva was superior to, or at least as effective, as an older drug designed to reduce bone complications from cancer, Zometa (zoledronic acid).
Side effects of Xgeva included lower blood calcium levels, and osteonecrosis of the jaw, a severe disease resulting from reduced blood flow to the jaw, the FDA said.
The drug was first approved under a different name, Prolia, to treat postmenopausal women at high risk of osteoporotic bone fractures.