Collegium Publishes Data From Xtampza(TM) ER Phase 3 Clinical Trial in the Journal PAIN
The Phase 3 study was a multicenter, double-blind, enriched enrollment, randomized withdrawal, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. The study met its primary endpoint which showed a statistically significant difference in average pain intensity from Randomization Baseline to Week 12 between the Xtampza ER and placebo groups (p<0.0001). All sensitivity analyses of the primary endpoint were also statistically significant. Xtampza ER had an adverse event profile consistent with other opioids, was well tolerated, and no new safety concerns were identified.
"The Phase 3 clinical trial results, coupled with the results from Collegium's abuse-deterrent development program, suggest that Xtampza ER not only represents an efficacious alternative opioid with abuse-deterrent properties, but could also benefit patients with dysphagia [difficulty swallowing], and mitigates the risk of overdose if inadvertently crushed or chewed," said Dr.
"The positive Phase 3 study results demonstrate that Xtampza ER is effective in treating patients with moderate-to-severe chronic pain, was well-tolerated, and has a safety profile consistent with other ER/LA opioids. Collectively, with its abuse-deterrent characteristics, flexible dosing options, and its efficacy and safety profile, Xtampza ER upon
About Xtampza ER
Collegium's lead product candidate, Xtampza ER, is an abuse-deterrent, extended-release, oral formulation of oxycodone, in development 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. Collegium developed Xtampza ER using its proprietary DETERx technology platform to address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.
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, submission for Xtampza ER, the Company's lead product candidate, was accepted for review by the
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 ER or any of our other product candidates from the
Douglas CarlsonVice President, Corporate Development firstname.lastname@example.org