Purdue Pharma receives FDA approval for pain management system
Sep 27, 2013 (MarketLine via COMTEX) --
Purdue Pharma L.P., a provider of both prescription and over-the-counter medicines, has received FDA approval for new 15mcg/hour dosage strength of Butrans Transdermal System CIII.
Four strengths of Butrans will now be available: 5, 10, 15 and 20 mcg/hour. Purdue expects to launch Butrans 15 mcg/hour commercially in the US in October 2013.
Butrans is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use: Butrans is not for use: as an as-needed (prn) analgesic; for pain that is mild or not expected to persist for an extended period of time; for acute pain; for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
Butrans is the first transdermal system that delivers a continuous release of buprenorphine for seven days. The active ingredient in Butrans Transdermal System is buprenorphine, a partial agonist at mu opioid receptor, and a Schedule III controlled substance.
"The approval of Butrans 15 mcg/hour dosage offers healthcare professionals added flexibility when using Butrans for the management of moderate to severe chronic pain," said Gary Stiles, M.D., Senior vice president, R&D, Purdue Pharma L.P. "The new strength provides another option when adjusting the dose to obtain an appropriate balance between adequate pain relief and opioid-related adverse reactions."
"The approval of the 15 mcg/hour patch of Butrans provides healthcare professionals the ability to individualize the dose of Butrans to the specific needs of patients," said Jeffrey A. Gudin, M.D., Director of The Pain Management and Wellness Center at Englewood Hospital and Medical Center.
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