STAMFORD, Conn. — Purdue Pharma has made its Butrans Transdermal System CIII opiod analgesic available by prescription.
Purdue said Thursday that the Butrans (buprenorphine) Transdermal System CIII is indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.
According to the company, the product is the first opioid analgesic that delivers continuous release of buprenorphine for seven days.
"The commercial launch of Butrans represents an important milestone in our long-term commitment to develop new products that fulfill unmet therapeutic needs of moderate to severe chronic pain patients," commented John Stewart, president and chief executive officer of Purdue Pharma.
Three strengths of Butrans are available by prescription in retail pharmacies nationwide: 5 mcg/hour; 10 mcg/hour; and 20 mcg/hour (NDC code 59011-752-04). The maximum dose of Butrans is 20 mcg/hour.
"Because individuals experience moderate to severe chronic pain and respond to treatment differently, additional therapeutic options can help us address the needs of our patients," stated Joseph Pergolizzi, M.D., adjunct faculty member at Georgetown University. "Butrans may provide health care professionals with a new tool for appropriate adult patients with moderate to severe chronic pain who meet the indication of the product."
Purdue said Butrans is a Schedule III product and can be abused in a manner similar to other opioid agonists. Working with the Food and Drug Administration, Purdue has developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans that includes a medication guide, elements to assure safe use, such as health care providers training, and a timetable for submitting assessments of the REMS.
