×

Collegium Announces Publication of Data on the In Vitro Assessment of IV Abuse of Xtampza ER in Journal of Opioid Management

CANTON, Mass., March 03, 2016 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced the publication of results from a laboratory-based extraction, injection and syringeability study for Xtampza® ER compared to other marketed opioid analgesics in peer-reviewed Journal of Opioid Management. The publication is titled, “In Vitro Assessment of the Potential for Abuse via the Intravenous Route of Oxycodone DETERx® Microspheres.”

Consistent with FDA’s guidance for developing abuse-deterrent formulations, the studies in the publication assess the ability to extract oxycodone for the purposes of IV abuse from Xtampza ER and active comparators. In addition, results from injectability and syringeability studies of Xtampza ER are included in the publication. Reformulated OxyContin® and immediate-release oxycodone were assessed as the active comparators.

The following link will take you to the full publication on the Journal of Opioid Management’s website: Link to Publication.

About Collegium Pharmaceutical, Inc.

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.

Forward-Looking Statements

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 FDA or foreign regulatory authorities; even if Xtampza ER obtains final approval, we may not be able to obtain the label claims that we are seeking from the FDA. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: our ability to commercialize our product candidates; the existence of any patent infringement or similar litigation relating to any of our products or product candidates, and costs and delays associated with such litigation; the size and growth potential of the markets for our product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our product candidates; the success, cost and timing of our product development activities, studies and clinical trials; the success of competing products that are or become available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates. These and other risks are described under the heading "Risk Factors" in the registration statement on Form S-1 (commission file number 333-208641), which was declared effective by the Securities and Exchange Commission ("SEC") on January 7, 2016, and those risks described from time to time in other reports which we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact: Douglas Carlson Vice President, Corporate Development dcarlson@collegiumpharma.com

Source:Collegium Pharmaceutical, Inc