hydrocodone bitartrate / Generic mfg. - LARVOL DELTA

SMART™ Opioids with Unprecedented Protection Against Abuse and Oral Overdose – Human Proof-of-Concept (PAINWeek 2024) - " Elysium conducted a phase 1, randomized, open-label, 2-part study to evaluate the safety and pharmacokinetics of oral O2P Hydrocodone vs. hydrocodone bitartrate (HCBT) in healthy adult subjects under fasted conditions under naltrexone blockade.Key objectives of the study were to:Evaluate the safety, tolerability, and pharmacokinetics of oral O2P Hydrocodone relative to a HCBT comparator following single oral doses in healthy adult subjects.Demonstrate reduced maximum plasma exposures (Cmax) of hydrocodone delivered from escalated oral doses of O2P Hydrocodone relative to an escalated comparator dose of HCBT (i.e. oral overdose protection).Identify appropriate doses of oral O2P Hydrocodone for subsequent clinical studies.POPULATION:The population for this study included male and female subjects, 18 to 55 years of age, inclusive, who were in general good health.STUDY Design: 93 healthy adult subjects were enrolled for the study with each subject participating in 1..."

Addiction (Opioid and Alcohol) • CNS Disorders • Insomnia • Pain • Psychiatry • Sleep Disorder • Substance Abuse

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

Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Quivive Pharma, Inc.

New P1 trial

A Longitudinal Analysis of Black Box Warnings: Trends and Implications for Drug Safety. (PubMed, Cureus) - "Neuropsychiatric warnings have been frequent over the past decade. Awareness of these warnings is essential to prevent adverse effects and enhance patient care, especially concerning drugs like guaifenesin/hydrocodone bitartrate, zolpidem, and montelukast commonly encountered in clinical practice."

Journal • Review • CNS Disorders • Immunology • Psychiatry

[PREPRINT ] An Analysis of Oxycodone and Hydrocodone Distribution Trends in Delaware, Maryland, & Virginia between 2006-2014 (medRxiv) - P=N/A | N=N/A | “Results: There was a 57.59% in the weight of oxycodone and hydrocodone between 2006-2014. Oxycodone prescriptions increased by 75.50% and hydrocodone by 11.05%. Oxycodone increased across all three states between 2006-2010 and declined until 2014. Hydrocodone also increased but to a lesser extent than oxycodone. There was substantial variability in daily average dose of both opioids at the county level in all states. Pharmacies accounted for largest portion of oxycodone (69.17%) and hydrocodone (75.27%) purchased in the region. Hospitals accounted for 26.67% of oxycodone and 22.76% hydrocodone purchased.”

Preprint • Retrospective data • CNS Disorders • Pain

Abuse and misuse of XTAMPZA® ER relative to other opioid analgesics (PAINWeek 2021) - "ADF ER opioids included OxyContin®, Embeda®, Hysingla® ER, Arymo® ER, and MorphaBond™ ER... Abuse and misuse exposures involving XTAMPZA ER reported to poison centers and XTAMPZA ER abuse cases among individuals entering treatment for opioid use disorders are infrequent relative to comparators. No abuse or misuse of XTAMPZA ER via unintended routes of administration was reported in the Poison Center Program. The proportion of cases involving use via unintended routes of administration was lower for XTAMPZA ER than for comparator drug groups among individuals entering treatment for opioid use disorders."

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

Non-Medical Use and Diversion of XTAMPZA ER in the General Population (PAINWeek 2021) - "The ER-ADF opioids included were OxyContin®, Hysingla®, and generic forms of ER oxycodone. The prevalence of NMU of XTAMPZA ER among adults who non-medically use opioids was small compared to other ER-ADF opioids and IR-SE oxycodone. XTAMPZA ER was rarely non-medically used independently of these two comparators. While NMU of XTAMPZA ER was less prevalent than comparators, the motivations and behaviors among those who non-medically used were similar."

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

Diversion and street price of XTAMPZA® ER relative to other prescription opioids (PAINWeek 2021) - "ADF ER opioids included OxyContin®, Embeda®, Hysingla® ER, Arymo® ER, and MorphaBond™ ER... Diversion of XTAMPZA ER was observed, though it comprised a smaller number of cases than would be expected based on prescription volume and drug potency. One appropriate comparator is IR oxycodone because it contains the same active ingredient in an easy to manipulate form. IR oxycodone had the highest number of cases."

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

Abuse-Deterrent Opioid Formulations and the Opioid Crisis: A Pharmacist's Perspective. (PubMed, Ther Drug Monit) - "Abuse-deterrent opioid products may lead to reductions in abuse, overdose, and overdose fatalities. However, cost, loopholes in deterrence mechanism, and possible diversion to other substances hinder their role in the opioid crisis. Multiple approaches must be employed to improve opioid safety, and further post-marketing and real-world analyses should be performed on available opioid formulations to assess their impact on abuse-related adverse events."

Journal • Addiction (Opioid and Alcohol)

Purdue Pharma L.P. to present data from research studies at PAINWeek 2015 Annual Conference (PRNewswire) - "Purdue Pharma L.P. will present results from 10 clinical and non-clinical research studies as well as host two satellite events during the 9th Annual PAINWeek® Conference, taking place Sept. 8-12, 2015 in Las Vegas."

Anticipated clinical data • Pain

Purdue Pharma L.P. presents data from research studies at American Pain Society 33rd Annual Scientific Meeting (PRNewswire) - "Purdue Pharma L.P. will present results from a number of research studies at the American Pain Society (APS) 33rd Annual Scientific Meeting, April 30-May 3, 2014, in Tampa, Fla."

Clinical data • Pain

Relationship between change in pain intensity and functional outcomes in patients with chronic pain receiving twice daily extended-release hydrocodone bitartrate. (PubMed) - J Opioid Manag - "Moderate or substantial levels of pain relief were associated with the greatest functional improvements in patients treated with HC-ER. These results may help define success of opioid therapy and determine if it should be continued or an alternative treatment should be tried."

Journal • Biosimilar • Depression • Pain

Pharmacokinetic profile and sustained 24-hour analgesia following administration of a novel hydrocodone single-entity, once-daily, extendedrelease tablet [Hysingla ER] formulated with abuse-deterrent properties: results of two studies (PAINWeek 2015) - P=NA, N=24; P3, N=922; NCT01400139; Sponsor: Purdue Pharma LP; "Once-daily, single-entity, extended-release HYD provided consistent plasma hydrocodone concentrations (PK study) and sustained analgesia over the 24-hour dosing interval (long-term study)."

P3 data • PK/PD data • Pain

Association Between Formulary Coverage and Use of Abuse-Deterrent Prescription Opioids, Risk for Abuse or Overdose, and Associated Healthcare Resource Utilization. (PubMed, Am Health Drug Benefits) - "An ADF opioid-including reformulated oxycodone hydrochloride (HCl) controlled-release (CR; reformulated OxyContin), morphine sulfate and naltrexone HCl extended-release (ER; Embeda), and hydrocodone bitartrate ER (Hysingla ER)-was considered covered if it was listed on the health plan's formulary...Broad formulary coverage of ADF opioids is associated with reduced rates of opioid abuse or overdose in real-world managed care populations. Health plan administrators and policymakers may consider improving the formulary coverage of ADF opioids as a strategy to ensure appropriate patient access to necessary pain medications while mitigating risk for opioid abuse or overdose."

HEOR • Journal

An in vitro approach for evaluating the oral abuse deterrence of solid oral extended-release opioids with properties intended to deter abuse via chewing. (PubMed, Int J Pharm) - "...In the present study, a chewing apparatus was utilized to develop an in vitro chewing method for Hysingla ER tablets, a prescription opioid with labeling describing abuse deterrence via the oral route when chewed...By contrast, an opioid product with labeling that does not describe abuse-deterrent properties showed lower resistance to chewing resulting in higher drug release. The results of the present study suggest that the chewing methodology evaluated in this work may provide a useful in vitro tool for the comparative evaluation of AD properties."

Journal • Preclinical

Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users. (PubMed, Pain Med) - "Incidences of adverse events for intranasal treatments were 52% for hydrocodone ER, 53% for hydrocodone powder, and 61% for HYD-OF. The statistically significant differences between hydrocodone ER vs hydrocodone powder and HYD-OF for the primary drug liking end points indicate a lower intranasal abuse potential with hydrocodone ER in healthy, nondependent, recreational opioid users."

Journal