Collegium Announces Publication of Data on the Durability of Pain Relief with Xtampza ER
The analysis of the data from the Phase 3 randomized withdrawal, double-blind, placebo-controlled, enriched-enrollment, parallel-group, multicenter, 12-week clinical study in patients with chronic low back pain showed limited use of acetaminophen, the only rescue medication used in the study. In addition, the analysis showed no increase in rescue medication consumption from 8 to 12 hours after dosing, which is the time interval commonly associated with end-of-dose failure leading to inadequate analgesic effect; these data suggest that subjects maintained pain relief over the entire dosing interval with twice daily administration of Xtampza ER.
"The results of this analysis suggest that Xtampza ER may provide clinicians an effective 12-hour, twice daily, formulation of oxycodone for their patients with chronic pain who require continuous, around-the-clock opioid analgesia for an extended period of time,” stated Dr.
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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.
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 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.
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 final approval for Xtampza ER or any of our other product candidates from the
Douglas CarlsonVice President, Corporate Development firstname.lastname@example.org