The FDA approves Collegium Pharmaceutical's (NASDAQ:COLL) supplemental New Drug Application (sNDA) to enhance the label of abuse-deterrent pain med Xtampza ER (oxycodone extended-release). There are three main additions:
Comparative oral pharmacokinetic data evaluating the effect of physical manipulation (crushing) of Xtampza ER to an abuse-deterrent version of Oxycontin (oxycodone hydrochloride extended-release tablets) and control (oxycodone immediate-release).
Results from an oral human abuse potential study comparing Xtampza ER to immediate-release oxycodone that showed lower Drug Liking for Xtampza.
The inclusion of an oral abuse-deterrent claim. Xtampza ER is the only single-agent oxycodone with this labeling.
Shares are up 2% premarket but only on 100 shares.
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