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Collegium Announces Positive Topline Results of Comparative Clinical Trial Evaluating the Effect of Crushing Xtampza(TM) ER Compared with OxyContin(R)

Collegium Pharmaceutical, Inc. COLL, -6.16% today announced positive topline results from a comparative clinical trial evaluating the effect of physical manipulation by crushing of Xtampza(TM) ER (oxycodone extended-release capsules) compared with the abuse-deterrent version of OxyContin [(R)] (oxycodone hydrochloride extended-release tablets). Xtampza ER, Collegium's first FDA approved product utilizing its proprietary DETERx [(R)] technology platform, is designed to maintain its ER pharmacokinetic (PK) profile after being subjected to common methods of manipulation including chewing and crushing the product prior to oral administration. Xtampza ER capsules are a twice-daily, opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The objective of the clinical trial was to assess the safety and PK of Xtampza ER when the capsule was taken intact compared with opening the capsule and crushing the capsule contents (microspheres) prior to oral administration. These treatments were compared with OxyContin intact, OxyContin crushed, and an immediate-release (IR) oxycodone tablet formulation that was crushed. The clinical trial was an open label, randomized, active-controlled, 5-treatment, 5-period, cross-over comparison in naltrexone-blocked, healthy subjects (n=41). The tools used to crush the formulations are commonly available household tools and were previously identified as the most effective tools to reduce the particle size for each respective product.

The top-line results of the clinical trial demonstrated the following:

  • Crushed Xtampza ER capsule contents (microspheres) (Cmax = 61.2 ng/mL; AUC = 549 hr � ng/mL) were bioequivalent to intact Xtampza ER capsules (Cmax = 56.9 ng/mL; AUC = 534 hr � ng/mL) with similar Tmax demonstrating that crushing the contents of Xtampza ER capsules did not alter the ER PK profile of Xtampza ER.
  • Crushed OxyContin tablets (Cmax = 79.9 ng/mL; AUC = 540 hr � ng/mL) were bioequivalent to crushed IR oxycodone tablets (Cmax = 78.1 ng/mL; AUC = 497 hr � ng/mL), demonstrating that crushing OxyContin compromised the integrity of the time-release formulation, transforming the drug-release PK profile from an ER profile to an IR profile.
  • At one hour after dosing, crushed OxyContin resulted in an approximately 5-fold higher mean plasma concentration than taking OxyContin intact and an approximately 4-fold higher mean plasma concentration than crushed Xtampza ER.

"This is the second comparative clinical trial to demonstrate that Xtampza ER maintains its ER properties after being subjected to crushing followed by oral administration, whereas OxyContin did not retain its ER properties after crushing, which resulted in OxyContin being bioequivalent to immediate-release oxycodone. The results of this study are consistent with our prior clinical trial comparing OxyContin to Xtampza ER," said Dr. Ernest Kopecky, Vice President, Clinical Development, Collegium.

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company focused on developing a portfolio of products...