FDA Approves Purdue Pharma’s 7.5 mcg/hour Dosage Strength of Butrans
Purdue Pharma announced that the U.S. Food & Drug Administration (FDA) approved a new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour. The Butrans Transdermal System is also approved to allow the use of two patches to facilitate dose adjustments during titration. The total dose from both patches should not exceed 20 mcg/hour. Purdue expects to launch Butrans 7.5 mcg/hour commercially in the United States in October 2014.
"This approval provides healthcare professionals another option to tailor Butrans therapy to the individual needs of appropriate chronic pain patients," said Todd Baumgartner, M.D., MPH, Vice President of Research & Development and Chief Medical Officer at Purdue Pharma L.P.
"The introduction of the 7.5 mcg/hour dosage strength further demonstrates Purdue's ongoing commitment to the management of chronic pain." Butrans is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Butrans also has the following Limitations of Use: Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended-release opioid formulations, reserve Butrans for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Butrans is not indicated as an as-needed (prn) analgesic.
Butrans was approved by the FDA in 2010 in the following dosage strengths: 5 mcg/hour, 10 mcg/hour and 20 mcg/hour. Butrans is the first and only transdermal system that delivers a continuous release of buprenorphine for seven days. The active ingredient in Butrans Transdermal System is buprenorphine and a Schedule III controlled substance which means prescriptions for Butrans may be called into the pharmacy and refills provided up to five times in a six month period.
Butrans has an abuse liability similar to other CIII opioids. For the use of two patches, patients should be instructed to remove their current patch and apply the two new patches adjacent to one another at a different application site.