Data on Arymo ER opioid treatment for severe pain published in Current Medical Research and Opinion journal.
Egalet Corporation announced that data on Arymo ER (morphine sulfate) extended-release (ER) tablets for oral use only tablets for oral use only –CII was published online in the Current Medical Research and Opinion journal. Arymo ER, formulated with Egalet's Guardian Technology, is approved 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.
Highlights from the publication include: 1.In human abuse potential (HAP) studies of abuse-deterrent (AD) opioids, characteristics of the non-AD comparator such as the formulation (e.g., immediate-release or extended-release) and the dose can potentially influence HAP study results. 2. How an AD opioid and its non-AD comparators are manipulated, the amount of active drug that can be extracted following manipulation, and the ways in which treatments are given such as in a solution versus swallowing the manipulated product with liquid can impact the outcomes of HAP studies. 3.There may be AD opioids where the retrospective assessments of Overall Drug Liking and/or Take Drug Again may not be as sensitive and/or predictive of the risk for misuse and abuse and, thus, less useful for determining the overall abuse deterrence profile of that AD opioid. 4.Tailoring the choices of the most appropriate primary and secondary endpoints of HAP studies to the specific AD technology/approach for the opioid under investigation may provide better insight into the potential of a particular AD product to deter abuse in real-world settings.
See- " Human abuse potential studies of abuse-deterrent opioids: lessons from oral and intranasal studies with morphine abuse-deterrent, extended-release, injection-molded tablets."- Lynn R. Webster, Eugene R. Viscusi, Colville Brown & Jeffrey M. Dayno Pages 1-24 | Received 01 Nov 2017, Accepted 23 Jan 2018, Accepted author version posted online: 25 Jan 2018 Download citation https://doi.org/10.1080/03007995.2018.1433144.