FDA approves Purdue's abuse-resistant hydrocodone

FDA approved Hysingla ER hydrocodone bitartrate from Purdue Pharma L.P. (Stamford, Conn.) to treat chronic pain for which alternative treatment options are inadequate. Hysingla is a once-daily, abuse-deterrent extended-release formulation of the opioid that received Priority Review.

Purdue said Hysingla is the first formulation of hydrocodone FDA recognizes as abuse-deterrent. In its approval announcement, the agency said the drug's label is consistent with its 2013 draft guidance addressing abuse-deterrent opioids (see BioCentury, Jan. 9, 2013). ...