Purdue Pharma has received FDA approval for Butrans (buprenorphine) Transdermal System CIII 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.
Butrans is available in three strengths 5, 10, and 20mcg/hour, each single patch is intended to be worn for seven days.
Butrans Transdermal System’s active ingredient is buprenorphine, a partial agonist at mu opioid receptors and an antagonist at kappa opioid receptors.
Purdue Pharma said that Butrans can be abused in a manner similar to other opioid agonists, legal or illicit.
Purdue Pharma has developed a risk evaluation and mitigation strategy (REMS) for Butrans with the FDA, that includes a Medication Guide, Elements to Assure Safe Use, such as healthcare providers training, and a timetable for submitting assessments of the REMS.