US FDA approves weekly skin patch for chronic pain
The Food and Drug Administration (FDA) of the United States has approved the use of Butrans, a once-weekly buprenorphine skin patch for the management of moderate to severe chronic pain.
The skin patch will be useful in patients requiring a continuous, around-the-clock opioid analgesic for an extended period, says Purdue Pharma LP, the maker of the transdermal system. Buprenorphine is a schedule III controlled substance.
The patch represents a new formulation for the opioid, which previously was available as an intramuscular/intravenous injection for the relief of moderate to severe pain.
"Healthcare professionals now have an important new option for appropriate adult patients suffering from moderate to severe chronic pain when an opioid may be needed to manage their pain," said Lynn R. Webster, MD, FACPM, FASAM, medical director of the Lifetree Clinical Research and Pain Clinic in Salt Lake City, Utah, in a company news release.
Two additional studies were conducted of the buprenorphine patch: one low back pain study failed to show efficacy, and an osteoarthritis study failed to show efficacy for both the patch and the active comparator.
Buprenorphine patches should be applied on a rotating basis to sites on the outer arm, upper chest, upper back, or side of chest once every 7 days. Buprenorphine is known to lower the blood pressure to dangerous levels and needs to be administered under a physician’s supervision.
Respiratory depression is the chief hazard of buprenorphine and other opioids. So extreme caution is advised when treating patients with significant chronic obstructive pulmonary disease or cor pulmonale; other risks for substantially decreased respiratory reserve include asthma, severe obesity, sleep apnea, and myxedema.