FDA OKs label update for Collegium's opioid pain med Xtampza ER; shares up 2% premarket

|About: Collegium Pharmaceutical (COLL)|By:, SA News Editor

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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