FDA approves new dosage strength for Purdue Pharma's Butrans

STAMFORD, Conn. — The Food and Drug Administration has approved a new dosage strength for a chronic pain patch made by Purdue Pharma, the drug maker said Tuesday.

Purdue announced the approval of the 15-microgram-per-hour strength of Butrans (buprenorphine). The drug is used to treat moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The new strength is in addition to the 5-microgram, 10-microgram and 20-microgram strengths already on the market, and it will be launched next month.

"The new strength provides another option when adjusting the dose to obtain an appropriate balance between adequate pain relief and opioid-related adverse reactions," Purdue SVP research and development Gary Stiles said.


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