oxymorphone IR / Generic mfg. - LARVOL DELTA

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

A retrospective review of the use of oxymorphone immediate release for long term pain control in cancer patients with gastrostomy tubes. (PubMed, Ann Palliat Med) - "Oxymorphone IR can be used successfully in cancer patients with G-tubes using an ORR of 3.5 to calculate dose from MEDD."

Journal • Retrospective data • Review • Addiction (Opioid and Alcohol) • Head and Neck Cancer • Oncology • Pain • Solid Tumor

"https://t.co/wxFzIe5r1m iR oxymorphone q8h into G- tube works well for cancer pain" (@edubru)

Oncology • Pain

"IR Oxymorphone q8h clamping venting G-tube works! https://t.co/wxFzIe5r1m #hpm #palliativecare" (@edubru)

Palliative care

"IR Oxymorphone q8h clamping venting G-tube works! https://t.co/wxFzIe5r1m #hpm #palliativecare" (@edubru)

Palliative care

"Oxymorphone IR can be used G-tubes with ratio of MEDD ratio of 3.5 https://t.co/wxFzIe5r1m #hpm #palliativecare" (@edubru)

Palliative care

Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects (clinicaltrials.gov) - P3; N=28; Terminated; Sponsor: Endo Pharmaceuticals; N=100 ➔ 28; Suspended ➔ Terminated; Released from PMR

Clinical • Enrollment change • Trial termination • Pain • Pediatrics

Quantification of serum levels in mice of seven drugs (and six metabolites) commonly taken by older people with polypharmacy. (PubMed, Fundam Clin Pharmacol) - "Serum samples from mice (n=5-6/group) treated with chronic oral doses of 3 polypharmacy regimens and 5 monotherapies were screened for drug and metabolite levels (metoprolol, α-hydroxymetoprolol, O-desmethylmetoprolol, omeprazole, 5-hydroxyomeprazole, omeprazole sulfone, acetaminophen, irbesartan, citalopram, oxybutynin, oxycodone, noroxycodone, oxymorphone and tenivastatin)...Polypharmacy appeared to affect drug levels in a preclinical model. This model can be used to understand pharmacokinetics of chronic polypharmacy, which could inform prescribing and improve outcomes for older people."

Journal • Preclinical

Polyethylene Oxide (PEO) molecular size determines the severity of atypical thrombotic microangiopathy in a guinea pig model of acute intravenous exposure. (PubMed, Toxicol Sci) - "In 2017, Opana ER was voluntarily removed from the US market based on concerns that its risks outweighed its therapeutic benefits...Further, only 7 MDa PEO dosing was associated with marked renal hypoxia. Taken together the current study defines renal injury risk with PEO formulations greater than 1 MDa that is driven by a robust intravascular hemolysis and potentially, tissue hypoxia."

Journal • Atypical Hemolytic Uremic Syndrome • Hematological Disorders • Hepatitis C Virus • Infectious Disease • Renal Disease • Thrombocytopenia • Thrombocytopenic Purpura

[VIRTUAL] Relative Potency of Intravenous Oxymorphone Compared to Other Mu-Opioid Agonists in Humans (CPDD 2020) - "The primary aim of this study was to examine the relative potency of IV oxymorphone compared to IV oxycodone, morphine and hydromorphone on pharmacodynamic outcomes in order to select doses for a subsequent fully randomized study of abuse liability and self-administration... Despite the relatively small sample size, this completed study detected robust oxymorphone effects and demonstrated that oxymorphone is far more potent than previously reported. Overall, these data align with recent surveillance reports indicating that, after adjusting for prescription rates/availability, oxymorphone was injected at the highest rates, relative to other prescription opioids."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Ophthalmology • Pain

"" #Opana is not the only one that needs to come off the market."n- @AndrewKolodny @CNNnnThx @US_FDA, pls pull #fentanyl + all #opioids next"

Biosimilar

[Long-term opioid therapy in chronic noncancer pain : A systematic review and meta-analysis of efficacy, tolerability and safety in open-label extension trials with study duration of at least 26weeks.] (PubMed) - "LtOT can be considered in carefully selected and monitored CNCP patients who experience clinically meaningful pain reduction with at least tolerable AE in short-term opioid therapy."

Journal • Biosimilar • Immunology • Inflammation • Oncology • Osteoarthritis • Pain

Development and impact of prescription opioid abuse deterrent formulation technologies (Drug Alcohol Depend) - "Reviewed is the FDA recent approval of a product label describing the abuse deterrent characteristics of OxyContin® (physical barrier formulation), and the FDA determination that studies were insufficient for an Opana® (physical barrier) ADF label. Additional reviewed marketed OpAs with ADF technologies include: Suboxone® and Embeda® (opioid agonist/antagonist combinations), Oxecta® (aversion technology), and Nucynta® (physical barrier)....The outcomes of the recent ADF labeling applications for OxyContin® (Tier 3 approval) and Opana® (non-approval) suggest that the threshold for ADF labeling will be appropriately high."

Review • Pain

Rat brain CYP2D activity alters in vivo central oxycodone metabolism, levels and resulting analgesia. (PubMed, Addict Biol) - "We assessed the role of rat brain CYP2D in orally administered oxycodone metabolism (in vivo brain microdialysis) and analgesia (tail-flick test) by inhibiting brain CYP2D selectively with intracerebroventricular propranolol (mechanism-based inhibitor) and inducing brain CYP2D with nicotine...Thus, brain CYP2D metabolism alters local oxycodone levels and response, suggesting that people with increased brain CYP2D activity may have reduced oxycodone response. Factors that alter individual oxycodone response may be useful for optimizing treatment and minimizing abuse liability."

Journal • Preclinical • Pain

Painful decision-making at FDA (Expert Opin Drug Saf) - "Additionally, the rewording of the labeled indication (from 'moderate to severe pain' to 'severe enough pain') for extended-release opioid analgesics, in an attempt to provide clarity, resulted in an equally if not more vague statement of appropriate use. Furthermore, the postmarketing requirement for continued data regarding safety and efficacy have been affirmed by FDA but some of the proposed means to acquire those data will likely result in unclear answers and may have undesired consequences."

Review • Pain

Endo announces FDA approval of a new formulation of Opana ER designed to be crush-resistant (Endo Pharmaceuticals) - FDA approved new formulation of Opana ER; Endo is committed to executing a seamless transition in 2012 from original formulation to new formulation, which utilizes the proprietary INTAC technology owned by Grunenthal; Endo also announced that U.S.P.T.O issued patent number 8,075,872 on Dec 13, 2011; The patent covers new formulation of Opana ER and is expected to provide protection until Nov 2023

FDA approval • Patent update • Product update • Pain

"Following a request from @US_FDA, Endo Pharmaceuticals has withdrawn OPANA ER from the market #opioidcrisis https://t.co/uPMb4CojiM" (@OriginsRecovery)

Biosimilar

"In its first big move under @SGottliebFDA, @US_FDA targets $ENDP's Opana ER https://t.co/FKG0a8oK8F"

Biosimilar

Drug approval reports (FDA) - Opana ER label revised on 05th Dec, 2013.

FDA event • Pain

"@US_FDA requests removal of Opana ER for risks related to abuse https://t.co/JQqrnEpX1H"

Biosimilar

Open-label safety and tolerability study of oxymorphone for acute postoperative pain in pediatric subjects. (clinicaltrials.gov) - P3, N=48; Completion date: Dec ’10 → Sep ’11

Pain

"$ENDP withdrawing Opana ER at @US_FDA's request due to #opioid IV abuse risk; background here https://t.co/HsEFfs3cAr" (@PinkSheetSutter)

Biosimilar

Extended-release oxymorphone for the treatment of patients with chronic pain: a pooled Safety analysis at morphine- equivalent doses ≥180 mg/d (PAINWeek 2012) - P=NA, N=422; Higher doses of oxymorphone ER (60-≥120 mg/d; equivalent to 180-≥360 mg/d oral morphine) did not appear associated with a marked increase in AEs that are typically considered opioid-related

Retrospective data • Pain

Endo Health Solutions Inc. to present at the Goldman Sachs 33rd Annual Global Healthcare Conference (PRNewswire) - Endo Health Solutions Inc announced that executive vice president and chief financial officer, will present a corporate overview at the Goldman Sachs 33rd Annual Global Healthcare Conference on Tuesday, June 5, 2012 at 2:40 p.m. PT; The conference will be held at Terranea in Rancho Palos Verdes, CA

Anticipated corporate presentation • Pain

Opana-induced thrombotic microangiopathy masquerading as thrombotic thrombocytopenic purpura. (PubMed) - Oxf Med Case Reports - "In our case report, a 47-year-old Caucasian male was admitted with a presentation suspicious for TTP then underwent therapeutic plasma exchange without clinical improvement. With supportive treatment only, the patient eventually improved and later admitted to intravenously abusing oral Opana 1-2 days prior to becoming ill."

Journal • Biosimilar • Demo Pain • Pain • Venous Thromboembolism