Purdue submits NDA for abuse-deterrent hydrocodone ER

Purdue Pharma L.P. (Stamford, Conn.) submitted an NDA to FDA for an abuse-deterrent formulation of once-daily hydrocodone bitartrate extended release (ER) to treat chronic pain. Purdue also reported data at the American Pain Society meeting showing that its product had significantly lower drug liking scores than non-abuse deterrent hydrocodone in non-dependent recreational opioid users when taken either intact, chewed, milled or intranasally. In March, Purdue said its abuse-deterrent formulation met the primary endpoint of reducing pain scores vs. placebo in a Phase III trial (see BioCentury Extra, March 12). ...