Collegium Pharmaceutical, Inc. Announces Final Study Results of its Successfully Completed Proof of Concept Study for its Abuse Deterrent Sustained Release Opioid Product

CUMBERLAND, R.I.--(BUSINESS WIRE)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced detailed study results from its recently completed proof of concept clinical trial for its abuse deterrent, sustained release, oral oxycodone formulation (COL-003). COL-003 is currently in development for the management of moderate to severe pain. The Company had previously reported the top line results of this study. In addition, the Company today announced that the U.S. Federal Drug Administration (FDA) has granted Fast Track Designation for COL-003. Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to address unmet medical needs. Fast track designation enables a sponsor to have more frequent and timely communication with the FDA regarding product development plans and may also result in eligibility for priority review of the New Drug Application.

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