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Tuesday, September 15, 2015 11:09:48 AM
FDA Panel Unanimously Recommended Approval (23-0) of Collegium’s (COLL-NASDAQ) Xtampza: Xtampza is an extended release formulation of oxycodone that should be taken after eating to maximize effectiveness. The review committee has flagged food effects as a safety concern for potential addiction and abuse. The FDA’s concern is that if a patient takes Xtampza without eating, there may not be sufficient pain relief— which could lead the patient to overdose in an attempt to achieve sufficient relief. This product is expected to be approved but we believe IPCI has a better formulation as it should not have the same issues with fed or fasting, as well as other competitive advantages.
??? taken after eating to maximize effectiveness. ??? I'm all confused - my understanding was that like Perdue's formulation, Xtampa also needed to be taken on an empty stomach -
Anyway - food intake requirements are a detriment to compliance - Big plus for IPCI
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