CONTEXT: Publication of a peer-reviewed article in the Journal of Pain Research describing the non medical use of Xtampza and other oxycodone medications. Collegium pharmaceuticals described the research as part of their commitment to responsible pain management as they look to provide surveillance of real-world data assessing the incidence of abuse and misuse.
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1. “Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Xtampza ER for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Xtampza ER is not indicated as an as-needed (prn) analgesic. IMPORTANT SAFETY INFORMATION. WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Addiction, Abuse, and Misuse. Xtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.”
2. “STOUGHTON, Mass., June 16, 2021 (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, “Nonmedical Use of Xtampza® ER and Other Oxycodone Medications in Adults Evaluated for Substance Abuse Treatment: Real-world Data from the Addiction Severity Index – Multimedia Version (ASI-MV®),” was published in the peer-reviewed medical journal, Journal of Pain Research.”
3. “While the analysis reported in this publication contributes to an understanding of the relative rates of nonmedical use of various opioid products, nothing in the findings should be construed as suggesting that Xtampza ER (oxycodone) extended-release capsules, does not have a high potential for addiction, abuse, or misuse.”
4. “Healthcare providers are strongly encouraged to . • complete a REMS-compliant education program,. • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,. • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and. • consider other tools to improve patient, household, and community safety.”
5. “Healthcare providers are strongly encouraged to do all of the following:. Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. Discuss with patients and/or their caregivers, with every prescription, the safe use, serious risks, and proper storage and disposal of these products.”
Source URL: https://finance.yahoo.com/news/collegium-announces-publication-real-world-200100290.html