FDA approves new dosage strength of Purdue Pharma's Butrans

STAMFORD, Conn. — Purdue Pharma announced that the Food and Drug Administration approved a new 7.5-mcg/hour dosage strength of Butrans (buprenorphine) transdermal system CIII, which brings the total strengths of the drug to five. Other dosage strengths include 5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.

The system also is approved to allow use of two patches to help with dose adjustments during titration, the company said, adding that the total dose from both patches shouldn't exceed 20 mcg/hour. Purdue expects to launch the new dosage strength 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, VP research and 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 used for the management of pain that's severe enough to require daily, long-term opioid treatment. Because of the risks of addiction, as well as abuse and misuse with opioids, the company noted that Butrans should be reserved for patients whose alternative treatment options have proven ineffective or not tolerated, or would be "otherwise inadequate to provide sufficient management of pain."

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