oxymorphone ER / Generic mfg. - LARVOL DELTA

Clinical Outcomes Translated to Healthcare Costs: Comparison of Buprenorphine Pain Medications with Full-agonist Extended-Release Opioids (PAINWeek 2025) - "Buprenorphine has potentially fewer negative side effects and adverse events than other opioids used for chronic pain treatment (Adler et al., 2024), such as full-agonist opioids fentanyl, hydromorphone, morphine and oxycodone (Dalal et al., 2021)... This was an observational, cross-sectional study design with three groups: buprenorphine buccal film (BBF), buprenorphine transdermal patch (BTP) and full-agonist extended-release opioids (FA-ER; included ER oxycodone, ER hydromorphone, ER oxymorphone, and ER tapentadol)... From 01 January 2020 to 31 December 2023, there were 276 reported exposures to BBF; 134 reported exposures to BTP; and 2,453 reported exposures to FA-CII opioids. Of these, intentional abuse or misuse exposures involving BBF and BTP were similar to one another and lower than rates of FA-ER exposures: BBF intentional abuse/misuse exposures n= 41 (14.9%); BTP exposures n=19 (14.2%); and FA-ER opioid exposures n= 665 (27.1%). Percentages of admissions to a..."

Clinical • Clinical data • HEOR • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Substance Abuse

Oxymorphone and Oxycodone Pharmacy Purchases in US Counties: Prelude to the Largest Rural Human Immunodeficiency Virus Outbreak in US History. (PubMed, Pharmacoepidemiol Drug Saf) - "Opana ER rapidly supplanted OxyContin in a vulnerable population that was at heightened risk for HIV who subsequently faced an immediate supply shock after its reformulation. Pharmacy transactions are critical for suspicious order monitoring and pharmacovigilance by US and international agencies especially during deleterious supply shocks in legal and illicit drug markets."

Journal • Human Immunodeficiency Virus • Infectious Disease

Curbing Opioid Abuse: Real-World Evidence of Abuse-Deterrent Formulations (PAINWeek 2024) - "Background: For patients who experience refractory chronic pain, opioid analgesics remain an important component of multimodal treatment; however, opioid misuse and abuse pose a serious and challenging public health problem.1 Prescription opioids were associated with approximately 45 deaths per day in 2021, totaling more than 17,000 deaths.2 Opioid abuse-deterrent formulations (ADFs) were developed as a component of a multifactorial strategy to combat the opioid epidemic.3-4 To date, there are 4 opioids (1 immediate release [IR] and 3 extended release [ER]) with US Food and Drug Administration (FDA)—approved abuse-deterrence label claims, including ROXYBONDTM IR (oxycodone), reformulated OXYCONTIN ER® (oxycodone), HYSINGLA ER® (hydrocodone), and XTAMPZA ER® (oxycodone). XTAMPZA ER had significantly lower rates of nonmedical use including nonoral nonmedical use than OXYCONTIN (P< 0.001) and the non-ADF oxycodone IR (P< 0.001) products in individuals..."

Clinical • HEOR • Real-world • Real-world evidence • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Psychiatry • Substance Abuse

Real-world impact of abuse-deterrent formulation of XTAMPZA ER in the context of behaviors around tampering with XTAMPZA® ER and other opioid products (PAINWeek 2023) - "Purpose/Objectives: This study compares the rate of tampering with XTAMPZA® ER to the rate of tampering with immediate-release (IR) single entity (SE) oxycodone, other ER oxycodone opioids, and ER oxymorphone in order to assess the efficacy of ADF technology in a real-world setting. Tampering with XTAMPZA® ER was reported less frequently than most comparator products in an OUD treatment center population, and NMU of this product was reported less frequently than other products in the general population. These findings highlight the impact of ADF technology in discouraging non-oral use among individuals with OUD. As such, there is a need for more research into the uptake of ADF opioids and identification of related barriers."

Clinical • Real-world • Real-world evidence • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

A Cross-Sectional Study of Tampering in Xtampza ER, an Abuse-Deterrent Formulation of an Extended-Release Opioid, in a Treatment Center Population. (PubMed, Clin Drug Investig) - "Drugs employing ADF technology may reduce the likelihood of tampering when compared to non-ADF formulations in a treatment-center population, which represents an opportunity for intervention in OUD among those still requiring pain management."

Journal • Observational data • Pain • Substance Abuse

Cross-sectional Study of Tampering in an Abuse-Deterrent Formulation of an Extended-Release Opioid in a Treatment Center Population (PAINWeek 2022) - "The chemical formulation for XTAMPZA ER’s ADF is oxycodone myristate, which keeps its extended-release properties even with tampering to the drug... The results of this study provide community-based, real-world evidence of the abuse deterrence of the oxycodone myristate formulation. These findings demonstrate that, in a sample of individuals entering a treatment program, oxycodone myristate is less likely to be manipulated than IR SE oxycodone and ER oxymorphone but was statistically no different than other abuse-deterrent oxycodone drugs. As seen by Severtson et al."

Clinical • Observational data • Addiction (Opioid and Alcohol) • CNS Disorders • Cognitive Disorders • Pain • Psychiatry • Substance Abuse

Relative Abuse of Crush-Resistant Prescription Opioid Tablets via Alternative Oral Modes of Administration. (PubMed, Pain Med) - "...CRTs (reformulated oxycodone extended-release [ER], reformulated oxymorphone ER, and tapentadol ER) were compared with non-CRT versions, morphine ER, and oxycodone immediate-release single entity...Results suggest the need for abuse-deterrent formulations designed to reduce abuse by oral administration with product manipulation, such as chewing. Advances in this area may reduce the overall abuse of prescription opioids and interrupt the progression from abuse by swallowing whole to oral administration involving product manipulation and other ROAs."

Journal

Structured Discontinuation vs Continued Therapy in Suboptimal and Optimal Responders to High-dose Long-term Opioids for Chronic Pain (clinicaltrials.gov) - P4; N=44; Terminated; Sponsor: Member Companies of the Opioid PMR Consortium; N=820 ➔ 44; Active, not recruiting ➔ Terminated; Trial primary completion date: Feb 2019 ➔ Apr 2018; Inability to recruit sufficient no. of subjects over an acceptable time period

Clinical • Enrollment change • Trial primary completion date • Trial termination