Collegium Licenses the U.S. rights to ONSOLIS® from BioDelivery Sciences
ONSOLIS is a Transmucosal Immediate-Release Fentanyl (TIRF) film indicated for the management of breakthrough pain in cancer patients (BTPc), 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS incorporates BioDelivery Sciences’ BioErodible MucoAdhesive (BEMA®) technology for rapid and controlled delivery of fentanyl, a Schedule II controlled substance, via buccal (inner cheek) administration.
ONSOLIS was originally approved by the
“ONSOLIS is highly complementary to Xtampza™ ER as it allows us to leverage our commercial infrastructure. Many physicians treating patients with cancer-related persistent pain using extended-release oral opioids also need to manage breakthrough pain and can do this effectively with Transmucosal Immediate-Release Fentanyl. Adding this product to our portfolio contributes to our mission of supporting responsible opioid prescribing for patients requiring opioid pain therapies,” said
“Breakthrough pain in cancer is different from persistent pain, since it can occur despite adequate therapy for persistent pain, and can significantly affect a patient’s well-being and quality of life,” said
“We are very pleased to enter into this important partnership with a company that has a focus in the pain management area, through their recent
Financial terms of the agreement include an upfront payment of
ONSOLIS is indicated for the management of breakthrough pain in cancer patients (BTPc), 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
For Important Safety Information Visit, http://www.bdsi.com/Onsolis.aspx
About Xtampza™ ER
Xtampza ER is an 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.
For Important Safety Information Visit, http://www.xtampzaer.com/
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.
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," "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. 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 products and 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 and 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 and 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 our Annual Report on Form 10-K for the year ended
Douglas CarlsonVice President, Corporate Development firstname.lastname@example.org