Advertisement Purdue Pharma Butrans Transdermal System CIII Gets FDA Approval - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Purdue Pharma Butrans Transdermal System CIII Gets FDA Approval

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.