Abstract
Prdue Pharma LP on July 1 announced that its new buprenorphine transdermal system, Butrans, received marketing approval from FDA and has a risk evaluation and mitigation strategy (REMS). Butrans appears to be the first buprenorphine product to have an approved REMS. FDA’s online list of approved REMS programs, updated on June 30, showed no entry for a buprenorphine product. According to the product’s labeling, the buprenorphine transdermal system is intended for use in the management of moderate to severe chronic pain in patients who require round-the-clock therapy with an opioid analgesic for an extended period of time. Each patch is intended to be worn for seven days. One of the eight contraindications to use of the product is postoperative pain. Although buprenorphine injection has been used in the treatment of postoperative pain, the labeling for the transdermal system states that the product must not be used for that purpose. Purdue Pharma said the REMS includes a medication guide, elements to assure safe use, also known as ETASU, and a timetable for the company to submit assessments on the REMS. One feature of the ETASU is the training of health care providers.
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