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Collegium Announces Publication of Data on Oral Abuse Potential of Xtampza ER
Collegium Pharmaceutical (Nasdaq:COLL) today announced the publication of “Evaluation of the oral human abuse potential of Oxycodone DETERx® formulation (Xtampza® ER),” in the peer-reviewed medical journal, Journal of Opioid Management. As quoted in the press release: The publication presents the results from a human abuse potential (HAP) study, which was designed to evaluate the abuse potential and pharmacokinetics …
Collegium Pharmaceutical (Nasdaq:COLL) today announced the publication of “Evaluation of the oral human abuse potential of Oxycodone DETERx® formulation (Xtampza® ER),” in the peer-reviewed medical journal, Journal of Opioid Management.
As quoted in the press release:
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 results demonstrated that intact and chewed Xtampza ER (fed or fasted) had statistically significantly lower peak “Drug Liking” when compared with crushed immediate-release oxycodone. Furthermore, Xtampza ER when taken chewed was bioequivalent to taking it intact as determined by maximum plasma concentration (Cmax) and area under the curve (AUC).
Intact and chewed Xtampza ER (fed or fasted) also demonstrated statistically significant lower “Take Drug Again” scores when compared with crushed immediate-release oxycodone. Additionally, statistically significant differences in peak effects between intact and chewed Xtampza ER (fed or fasted) treatments compared with crushed IR oxycodone were seen for other secondary endpoints such as “Overall Drug Liking,” “Feeling High,” “Any Drug Effects” and “Good Drug Effects.”
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