AUSTIN, TX—Researchers at the American Pain Society’s 30th Annual Scientific Meeting discussed data from a review of spontaneous adverse events reported with Embeda (morphine sulfate and naltrexone HCl) treatment, with a focus on events potentially related to product tampering.
Vincent Badalamenti and colleagues, from Pfizer, Inc, Cary, NC, sought to assess the outcomes associated with tampering of Embeda capsules, which were designed to address prescription opioid abuse associated with tampering (eg, crushing or chewing then swallowing, snorting or injecting). Each capsule contains individual morphine sulfate pellets with a sequestered inner core of naltrexone, an opioid antagonist. When taken as prescribed, morphine is released in an extended-release profile. However, when the pellets are crushed or chewed, both the morphine and naltrexone are released.
During Embeda’s first year of approval, 182 individual case reports were received, of which 33 (18%) were classified as serious and 149 (82%) were non-serious. There were 11 cases of confirmed or suspected manipulation of Embeda. Of the 11, six cases were reported as confirmed Embeda tampering: two involved injection of crushed Embeda and four cases reported oral ingestion of manipulated Embeda. None of the six cases resulted in typical morphine overdose symptoms, euphoria, or the intended effects of drug abuse. The additional five cases of suspected tampering reported patients who experienced stigmata associated with withdrawal. None of the 11 cases resulted in fatality.
The investigators conclude that reports of use of manipulated Embeda were consistently associated with either withdrawal reactions or events not typical of opioid abuse. The results of the review support that Embeda is performing as the product was designed by creating limits and impediments to abuse. They believe that further monitoring is needed to establish whether the Embeda formulation has an impact on mitigating its abuse.