Collegium Announces Publication of "Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations With Abuse-Deterrent Properties," in Pain Medicine
The objective of the clinical trial was to assess the safety and pharmacokinetics of Xtampza ER when the capsule was taken intact after oral administration compared with opening the capsule and crushing the capsule contents (microspheres) prior to oral administration. These treatments were compared with reformulated OxyContin® ("OxyContin") intact, OxyContin crushed, and an immediate-release (IR) oxycodone tablet formulation crushed in naltrexone-blocked, healthy subjects (n=42). The clinical trial was an open label, randomized, active-controlled, 5 treatment, 5 period, cross-over comparison design. The selected crushing techniques were previously identified in the laboratory as the most effective methods of reducing the particle size for each respective product. These crushing methods are also commonly employed by abusers to destroy the time-release mechanism of extended-release (ER) opioid formulations to make the drug more abusable.
Key publication highlights:
- Crushing Xtampza ER demonstrated no increase in Cmax, Tmax, or AUC and was bioequivalent to taking Xtampza ER intact capsules.
- Crushing reformulated OxyContin demonstrated an increase in Cmax and a decrease in Tmax, and was bioequivalent to crushed IR oxycodone tablets.
- Crushing Xtampza ER demonstrated no increase in Abuse Quotient ("AQ" = Cmax/Tmax) while crushing reformulated OxyContin increased the AQ four times, which was similar to the AQ for crushed IR oxycodone tablets.
A copy of the publication is available at: http://onlinelibrary.wiley.com/doi/10.1111/pme.12834/abstract
Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx® technology platform for the treatment of chronic pain and other diseases. The DETERx oral drug delivery technology is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options. The new drug application, or NDA, filing for Xtampza ER, the Company's lead product candidate, was accepted by the
OxyContin® is a registered trademark of
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that we will obtain approval for Xtampza or any of our other product candidates from the
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