Business
Collegium Announces Publication of “Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza® ER” in Pain Medicine
STOUGHTON, Mass., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the
About this update from Collegium Pharmaceutical, Inc.
[{"type":"text","content":" STOUGHTON, Mass., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today announced a publication titled, “Postmarketing Analysis of Misuse, Abuse and Diversion of Xtampza ER,” was published in the peer-reviewed medical journal, Pain Medicine.\n “As a company committed to being the leader in responsible pain management, we are encouraged by findings in this analysis which found that over the first 3 years of Xtampza ER’s launch, when prescriptions increased 50-fold, cases from poison centers, substance abuse treatment centers and a diversion monitoring program were infrequent and did not increase, and Xtampza ER had low rates of misuse, abuse and diversion relative to specified prescription opioid categories,” said Richard Malamut, M.D., Executive Vice President and Chief Medical Officer of Collegium. “The publication of the postmarketing analysis of real-world evidence related to Xtampza ER provides data that can enrich the scientific and clinical evaluation of abuse deterrent formulations. We remain committed to postmarketing studies and surveillance and look forward to continuing to share Xtampza ER real-world evidence with the FDA and the medical community.” The objective of the analysis was to evaluate abuse, misuse and diversion of Xtampza ER (oxycodone) extended-release capsules, CII. The publication presents certain real-world evidence related to abuse, misuse and diversion of Xtampza ER assessed using Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) system data sources. Xtampza ER was compared to immediate-release oxycodone, other abuse-deterrent formulation extended-release products, and non-abuse-deterrent formulation extended-release products. Because of the inherently less controlled nature of the data generated in real-world studies, it is critical to interpret them with caution. In particular, and among other issues, in observational studies that leverage existing data rather than prospectively collected data, the impact of confounding factors on the findings may be difficult to ascertain. The data in this publication represent a single snapshot in time and rates of abuse as reflected in these data may change as changes occur in the social environment and legal, r...