Collegium releases positive new data on Xtampza vs OxyContin

US drugmaker Collegium Pharmaceutical (Nasdaq: COLL) has released positive new data from a head-to-head trial of Xtampza ER (oxycodone extended-release capsules) versus market leader Purdue Pharma’s OxyContin (oxycodone hydrochloride extended-release tablets). Despite the positive data, the company’s shares fell 8.58% to $17.05.

Xtampza ER, which gained US Food and Drug Administration approval last week and is expected to launch in mid-2016, is the first FDA-approved product utilizing Collegium’s proprietary DETERx technology platform. It 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.