OxiFast (oxycodone immediate release) / Purdue, Shionogi, Mundipharma - LARVOL DELTA

Opioid Abuse Deterrent Formulations: Evaluation of Nonmedical Use of Other Prescription Opioid Substances and Routes of Administration in Adults Evaluated for Substance Use Treatment with the Addiction Severity Index-Multimedia Version (ASI-MV®) (PAINWeek 2025) - "Three groups were created: assessments reporting XTAMPZA ER (ADF) NMU, assessments reporting other oxycodone ER (all oxycodone ER products except Xtampza ER - ADFs) NMU, and assessments reporting oxycodone Immediate Release (IR) (non-ADFs) NMU. Of the 341,851 ASI-MV assessments completed from 01 July 2016 through 31 December 2023, 141 assessments reported past 30-day XTAMPZA ER NMU; 4,935 reported other oxycodone ER NMU; and 20,394 reported oxycodone IR NMU. 138 of the 141 (97.9%) XTAMPZA ER NMU assessments also reported other prescription opioid NMU; 4,733 of the 4,935 (95.9%) other oxycodone ER NMU assessments also reported other prescription opioid NMU, and 16,517 of the 20,394 (81.0%) oxycodone IR NMU assessments also reported other prescription opioid NMU. Nonoral routes of administration (ROAs) were indicated in 22.0% of assessments reporting XTAMPZA ER NMU including snorting only (9.9%); oral ROAs and snorting (5.0%); injecting only (2.1%); oral ROAs, snorting,..."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry

Appropriateness of oxycodone use for acute pain in surgical and obstetric departments using a clinical data warehouse. (PubMed, Br J Clin Pharmacol) - "The majority of patients treated with oxycodone in surgery had inappropriate prescribing. Considering the known risk of developing opioid use disorder after a first administration in surgery, important educational effort seems needed."

Clinical data • Journal • Addiction (Opioid and Alcohol) • Obstetrics • Pain • Substance Abuse

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (clinicaltrials.gov) - P2 | N=170 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Oncology

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2024 ➔ Jul 2025

Enrollment closed • Trial primary completion date • Oncology

Opioid-related clinical outcomes and associated healthcare costs following abuse/misuse of oxycodone formulations: A HEOR analysis from real-world data. (PubMed, J Opioid Manag) - "This study is the first of its kind to synthesize clinical outcomes with opioid-related healthcare costs, suggesting that even when Xtampza ER is abused/misused, the rates of major effect/death, ED visits, and hospital admissions were significantly lower than those for other oxycodone-containing medications, resulting in relatively low downstream opioid-related healthcare costs."

Clinical • Clinical data • HEOR • Journal • Observational data • Real-world • Real-world evidence

A Review of the Primary and Secondary Outcomes From a Phase I Study Comparing the Respiratory Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration (PAINWeek 2024) - "The study was conducted to compare the effects of BBF and oxycodone immediate-release (IR) administration on respiratory drive, pharmacokinetics (PK) parameters, oxygen saturation, and pupillary-constricting effects.6-8 This randomized, double-blind, placebo-controlled, double-dummy crossover study enrolled 19 healthy participants who self-identified as recreational users of opioids, with 15 participants completing the study. Respiratory depression (maximum decrease in minute ventilation) did not decrease significantly with BBF relative to placebo.6 Oxycodone 60 mg resulted in a significant, dose-dependent decrease in respiratory drive (P = 0.01). Time to peak drug concentration was similar between doses for each individual drug, while the mean decrease in oxygen saturation was greater for oxycodone compared with BBF.7 Although similar pupil constriction levels were observed, miosis was delayed with BBF compared with oxycodone.8Conclusions/Implications for future..."

P1 data • Review • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Psychiatry

Kinetic Insights into the Antioxidant Effect of Isatin-Thiosemicarbazone in Biodiesel Blends. (PubMed, Antioxidants (Basel)) - "Isatin-thiosemicarbazones were tested as additives in blends at a concentration of 3000 parts per million (ppm) using an oxifast device and were compared with the chemical antioxidant Trolox...The kinetics of thermal decomposition of isatin-thiosemicarbazones under non-isothermal conditions were determined using the Kissinger, Ozawa, and Boswell techniques. The activation energies of compounds 1 and 2 were calculated as 137-147 kJ mol-1 and 173-183 kJ mol-1, respectively."

Journal

Prepacked Take-Home Analgesia in Outpatient Hand Surgery Reduces Opioid Dispensation. (PubMed, Acta Chir Orthop Traumatol Cech) - "The introduction of prepacked analgesia bags dramatically reduced the quantity of opioids prescribed after outpatient hand surgery. Patient satisfaction was high and the postoperative pain level was acceptable."

Journal • Surgery • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Psychiatry

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Mar 2024

Enrollment open • Surgery • Trial initiation date • Oncology

Influences of Software Changes on Oxycodone Prescribing at an Australian Tertiary Emergency Department: A Retrospective Review. (PubMed, Pharmacy (Basel)) - "This study investigated the effect of changes to electronic prescribing software on prescriptions with an auto-populated quantity of oxycodone immediate release (IR) from an Australian tertiary emergency department following the implementation of national recommendations for reduced pack sizes...The prescriber's years of practice, patient age and patient sex were found to influence increased prescription sizes. Reduced quantity of oxycodone tablets prescribed was achieved by alteration of prescribing software prefill parameters, providing further evidence to support systems-based policy interventions to influence health care providers behaviour and to act as a forcing function for prescribers to consider opioid stewardship principles."

Journal • Retrospective data • Review

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Surgery • Oncology

Restriction of oxycodone in the emergency department (ROXY-ED): A randomised controlled trial. (PubMed, Br J Pain) - "The primary intervention was ROXY, through removal of all oxycodone immediate release tablets from the ED imprest, with availability of a small supply after senior clinician approval...Restricted access to oxycodone was superior to education and guideline modifications alone for reducing oxycodone use in the ED and reducing discharge prescriptions of oxycodone from the ED. The addition of simple restrictive interventions is recommended to enable rapid changes to clinician behaviour to reduce the potential harm associated with the prescribing of oxycodone in the ED."

Journal • Addiction (Opioid and Alcohol) • Pain

Differences in severity of poison centers exposures involving XTAMPZA ER versus other opioid analgesics. (PubMed, Pain Manag) - "Xtampza ER was compared with other ADF opioids, non-ADF extended-release opioids, single-entity oxycodone immediate-release, unspecified oxycodone and unspecified morphine. Results & No Xtampza ER exposures involved unintended routes of administration. Xtampza ER exposures were less likely to be abuse, misuse or suspected suicidal, and medical outcomes were less severe than comparators."

Journal • Pain

Non-intrusive Detection of Temporary Neurologic Impairment By Opioids (clinicaltrials.gov) - P1/2 | N=14 | Completed | Sponsor: Mayo Clinic | Withheld ➔ Completed | Phase classification: PN/A ➔ P1/2

Phase classification • Trial completion

Medical opioid disposal in Fukuoka and Kumamoto cities. (PubMed, Yakugaku Zasshi) - "In Fukuoka city, the most disposed opioid was 20 mg Oxycontin, worth approximately 940,000 ¥...The most disposed opioid was 5 mg Oxinorm at a cost of 600,000 ¥ at the medical institutions over the 2-year study period...These results indicate that the amount of disposed opioids is huge. Small package simulation studies suggest that smaller package units of MS-Contin, Anpec suppository, and Abstral sublingual tablet may be able to reduce the amount of disposed opioids."

Journal

Oral oxycodone-induced respiratory depression during normocapnia and hypercapnia: a pharmacokinetic-pharmacodynamic modeling study. (PubMed, Clin Pharmacol Ther) - "Twenty-four male and female volunteers received 20 (n=12) or 40 (n=12) mg oral oxycodone immediate-release tablets. The similar or better likelihood for antinociception relative to respiratory depression may be related to oxycodone's receptor activation profile or to is high likeability that possibly alters the modulation of nociceptive input. Oxycodone differs from other μ-opioids, such as fentanyl, that have a consistent negative utility."

Journal • PK/PD data • CNS Disorders • Depression • Mood Disorders • Pain • Psychiatry

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Ensysce Biosciences | Active, not recruiting ➔ Completed

Trial completion • Addiction (Opioid and Alcohol)

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Ensysce Biosciences | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2023 ➔ Jan 2023

Enrollment closed • Trial completion date • Addiction (Opioid and Alcohol)

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Ensysce Biosciences

New P1 trial • Addiction (Opioid and Alcohol)

NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Medlab Clinical | Trial completion date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Aug 2023 ➔ Feb 2024

Monotherapy • Trial completion date • Trial primary completion date • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Cost-effectiveness of tapentadol immediate release versus oxycodone immediate release for acute post-operative pain after major hip surgeries. (PubMed, Curr Med Res Opin) - "In the probabilistic sensitivity analysis, 84.2% of the simulations were in favour of tapentadol IR at the WTP threshold. Tapentadol IR may be more cost-effective than oxycodone IR for the treatment of acute post-operative pain after major hip surgeries."

HEOR • Journal • Orthopedics • Pain

Multimodal Analgesia in Shoulder Arthroplasty (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Rush University Medical Center; N=18 ➔ 0; Terminated ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Anesthesia • Musculoskeletal Pain • Orthopedics • Pain

Proposed Risk Stratification of Drug Effect on Inducing Respiratory Depression (PAINWeek 2021) - "We performed a proof-of-concept study to demonstrate the ability of the VRH model to assess a drug’s potential to cause respiratory depression. We demonstrated that 30 mg oxycodone immediate-release had a significantly higher VRH at the expected Cmax. The present study suggests that VRH could be a validated experimental model to assess respiratory depression and provide the FDA with data that could be used in boxed warnings."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mood Disorders • Pain • Psychiatry • Substance Abuse

Gastrointestinal Adverse Events in Hospitalized Patients Following Orthopedic Surgery: Tapentadol Immediate Release Versus Oxycodone Immediate Release. (PubMed, Pain Physician) - "Tapentadol IR is associated with similar GI ADE occurrence compared with oxycodone IR in patients with orthopedic postoperative pain during hospitalization."

Adverse events • Clinical • Journal • Addiction (Opioid and Alcohol) • Constipation • Gastroenterology • Gastrointestinal Disorder • Orthopedics • Pain

Effect of intravenous oxycodone on the physiologic responses to extubation following general anesthesia. (PubMed, BMC Anesthesiol) - "Intravenous oxycodone attenuated alterations of hemodynamics and blood hormones associated with extubation during emergence from general anesthesia."

Journal • Anesthesia • Respiratory Diseases