Collegium Pharma (COLL) Announces Publication of HAP Study Data on Xtampza ER

September 29, 2016 7:03 AM EDT
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Collegium Pharmaceutical, Inc. (Nasdaq: COLL) announced the publication of “Oral Human Abuse Potential of Oxycodone DETERx® (Xtampza ER),” in the peer-reviewed medical journal, The Journal of Clinical Pharmacology.

The publication presents the results from a human abuse potential (HAP) study, which was designed to evaluate the abuse potential and pharmacokinetics of oral administration of intact Xtampza® ER (oxycodone extended-release), oral administration of chewed Xtampza ER, and oral administration of crushed immediate-release oxycodone in non-dependent, recreational drug abusers.

The study results demonstrated that chewed Xtampza ER had significantly lower peak "Drug Liking" (Emax) when compared with crushed immediate-release oxycodone (p < 0.0001). Furthermore, there was no difference in the pharmacokinetics when Xtampza ER was chewed or taken intact as determined by the bioequivalence parameters (Cmax and AUC).

Dr. Ernest Kopecky, lead author on the publication and Vice President of Clinical Development stated “Oral administration is among the most widespread types of abuse, particularly for oxycodone products. Because of the larger amounts of opioid in ER formulations, drug abusers will often chew or crush a product to decrease the time-to-onset and increase the magnitude of the euphoric drug effects. The data from this study indicate that chewing Xtampza ER does not compromise the extended-release profile of the DETERx drug delivery system, thereby mitigating the potential for increased drug liking after tampering and protecting against dose dumping - the release of a potentially fatal, bolus dose of oxycodone.”

Abuse of Xtampza ER by injection and by the nasal route of administration, as well as by the oral route is still possible.

The following link will take you to the full publication: Journal of Clinical Pharmacology.

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