Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018

Priya Jain, Kimberley McKinnell, Rose Marino, Prashanthi Vunnava, Marie A. Liles-Burden, Avani Desai, Madé Wenten, James Fratantonio, Sarah C. Akerman, Maria A. Sullivan and Gary Bloomgren ()
Additional contact information
Priya Jain: Alkermes, Inc.
Kimberley McKinnell: Alkermes, Inc.
Rose Marino: Alkermes, Inc.
Prashanthi Vunnava: Alkermes, Inc.
Marie A. Liles-Burden: Alkermes, Inc.
Avani Desai: Alkermes, Inc.
Madé Wenten: Alkermes, Inc.
James Fratantonio: Alkermes, Inc.
Sarah C. Akerman: Alkermes, Inc.
Maria A. Sullivan: Alkermes, Inc.
Gary Bloomgren: Alkermes, Inc.

Drug Safety, 2021, vol. 44, issue 3, No 7, 359 pages

Abstract: Abstract Introduction After treatment with naltrexone extended-release injectable suspension (XR-NTX), a µ-opioid receptor antagonist, opioid tolerance is reduced from pretreatment baseline. Patients may be vulnerable to opioid overdose if they attempt to override the blockade during treatment, at the end of a dosing interval, after missing a dose, or after discontinuing treatment. Objective We analyzed postmarketing data to characterize reporting rates of opioid overdose during treatment with and after discontinuation of XR-NTX. Methods Postmarketing adverse event reports within the XR-NTX safety database, received 2006–2018, for patients treated with XR-NTX for any indication were reviewed for opioid overdose cases. Assessable cases were categorized by timing of the event from the last dose of XR-NTX (latency): ≤28 days (on treatment), 29–56 days, and >56 days from last dose of XR-NTX. Within each latency group, cases were further classified as serious and, of those, cases that had a fatal outcome. Results During the 12-year period, an estimated 495,602 patients received XR-NTX. Opioid overdose was reported in 161 cases; of these, 66 contained sufficient information to determine latency. Reporting rates of opioid overdose per 10,000 patients treated were similar among latency groups: 0.54 for ≤28 days (0.24 fatal), 0.34 for 29–56 days (0.16 fatal), and 0.44 for >56 days (0.40 fatal) from the last dose of XR-NTX. Conclusions Over the 12-year period, the reporting rates of opioid overdose were similar during treatment with or after discontinuation of XR-NTX and

Date: 2021
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DOI: 10.1007/s40264-020-01020-4

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