A Multicenter, Randomized, Phase IIa/IIb Clinical Trial of 3D1002 Combined With Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Patients With Moderate to Severe Cancer Pain

This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of moderate or severe cancer pain.

Start Date01 Sep 2024

Sponsor / Collaborator

Aitisi Biotechnology (Shanghai) Co. Ltd.

NCT06444997 / Not yet recruitingPhase 4IIT

Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients: A Pilot Study

The goal of this clinical trial is to learn if oxycodone hydrochloride works to manage pain in patients requiring mechanical ventilation. It will also assess the safety of oxycodone hydrochloride. The main questions it aims to answer are:
1. Does oxycodone hydrochloride effectively lower the CPOT (Critical Care Pain Observation Tool) score in mechanically ventilated patients?
2. What medical problems do participants have when using oxycodone hydrochloride? Researchers will compare oxycodone hydrochloride to remifentanil to see if oxycodone works better to manage pain in these patients.
Participants will:
Receive either oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h or remifentanil injection at a dose of 2-9 μg/kg/h.
Have their pain scores assessed every 15 minutes until the CPOT score is less than 3. After reaching the target pain score, assessments will be done every 4 hours.
Have their vital signs and monitoring data recorded.
Have analgesia and sedation scores recorded from days 1 to 7 after administration, with drug dosages adjusted based on pain scores.
Have the incidence of adverse reactions and changes in gastrointestinal function observed and recorded from days 1 to 7 after administration.
If extubated within 7 days, relevant data will be collected based on the time of extubation.
Be followed up on day 28 through the electronic medical record system to gather data on the extubation success rate and incidence of complications within the 28-day period.

Start Date01 Jun 2024

Sponsor / Collaborator

Zhongshan Hospital Fudan University

ChiCTR2400080454 / SuspendedPhase 4IIT

Effect of oxycodone hydrochloride injection in patients diagnosed with sepsis induced acute lung injury

Start Date01 Apr 2024

Sponsor / Collaborator

Tianjin Nankai Hospital

100 Clinical Results associated with Oxycodone Hydrochloride

100 Translational Medicine associated with Oxycodone Hydrochloride

100 Patents (Medical) associated with Oxycodone Hydrochloride

468

Literatures (Medical) associated with Oxycodone Hydrochloride

02 Nov 2023·Education for primary care : an official publication of the Association of Course Organisers, National Association of GP Tutors, World Organisation of Family Doctors

‘Dopesick’; why a critical view of the literature may save your patient’s life

Article

Author: O'Connor, Raymond

INTRODUCTION:

Teaching critical literature appraisal is challenging. Providing a compelling clinical context using 'cinemeduation' stimulates interest in the topic.

METHODS:

After watching the first episode of the mini-series 'Dopesick', where the scope, timeline and extent of the problem of opioid abuse are clearly seen, abstracts of the period literature strongly supporting the use of Oxycontin for use in chronic pain are shown. All were published in highly ranked medical journals. A simple paper evaluation structure is suggested. It is PPICOREAD which stands for the following questions: Who Paid for the study? What was the Population studied? What was the Intervention given in the study? What was the Control group used? What was the Outcome and was it of clinical significance to you? Was the trial Registered? Was there an Educational element for you? Was there anything Applicable to your practice? What was the Duration of the trial? Is this duration sufficient to reassure you that the trial is relevant to your practice?

RESULTS:

The very poor quality and dishonest nature of the conclusions of these papers are quickly and easily uncovered in a supervised workshop. The causes for these clear discrepancies are discussed. The devastating consequences are described.

01 Oct 2023·Palliative & supportive care

Naldemedine-induced opioid withdrawal with restlessness as the predominant symptom in a palliative care setting

Article

Author: Sato, Ryota ; Uchida, Nozomu ; Onishi, Hideki ; Ishida, Mayumi ; Yamaguchi, Takefumi ; Sakimoto, Takehiko ; Takahashi, Takao ; Ooya, Yoshitaka

Abstract:

Objectives:

Opioid analgesics play a central role in cancer pain treatment; however, it has been reported that opioid-induced constipation (OIC) develops in 80% of patients using opioid analgesics and leads to a decrease in quality of life. Naldemedine improves constipation without affecting the analgesic action of opioid analgesics via peripheral μ-opioid receptors.

Methods:

We report a terminally ill cancer patient who was diagnosed with opioid withdrawal syndrome (OWS) based on symptoms centered around restlessness and sweating that developed 43 days after administration of naldemedine for OIC.

Results:

The patient was a 78-year-old woman who was diagnosed with stage IVB uterine sarcoma in October, 1 year prior to her visit to our clinic, and underwent chemotherapy after surgery, but the disease became progressive. Thereafter, metastasis to the fourth thoracic vertebrae (Th4) was identified, and loxoprofen and acetaminophen were started for pain at the metastatic site. Oxycodone hydrochloride hydrate 10 mg/day was additionally administered on postoperative day 11, followed by naldemedine 0.2 mg/day for OIC. On the 43rd day after administration, the patient began to wander the hospital ward in a wheelchair and became noticeably restless. OWS due to naldemedine administration was suspected, and naldemedine was discontinued. The symptoms improved 7 days later, and no similar symptoms were observed thereafter.

Significance of results:

Patients receiving palliative care often exhibit psychiatric symptoms such as anxiety and depression, but OWS due to naldemedine should also be considered as a potential cause.

28 Jul 2023·Journal of medical Internet research

Results and Methodological Implications of the Digital Epidemiology of Prescription Drug References Among Twitter Users: Latent Dirichlet Allocation (LDA) Analyses.

Article

Author: Valdez, Danny ; Rao, Varun K ; Eddens, Katherine S ; Agley, Jon ; Parker, Maria A

BACKGROUND:

Social media is an important information source for a growing subset of the population and can likely be leveraged to provide insight into the evolving drug overdose epidemic. Twitter can provide valuable insight into trends, colloquial information available to potential users, and how networks and interactivity might influence what people are exposed to and how they engage in communication around drug use.

OBJECTIVE:

This exploratory study was designed to investigate the ways in which unsupervised machine learning analyses using natural language processing could identify coherent themes for tweets containing substance names.

METHODS:

This study involved harnessing data from Twitter, including large-scale collection of brand name (N=262,607) and street name (N=204,068) prescription drug-related tweets and use of unsupervised machine learning analyses (ie, natural language processing) of collected data with data visualization to identify pertinent tweet themes. Latent Dirichlet allocation (LDA) with coherence score calculations was performed to compare brand (eg, OxyContin) and street (eg, oxys) name tweets.

RESULTS:

We found people discussed drug use differently depending on whether a brand name or street name was used. Brand name categories often contained political talking points (eg, border, crime, and political handling of ongoing drug mitigation strategies). In contrast, categories containing street names occasionally referenced drug misuse, though multiple social uses for a term (eg, Sonata) muddled topic clarity.

CONCLUSIONS:

Content in the brand name corpus reflected discussion about the drug itself and less often reflected personal use. However, content in the street name corpus was notably more diverse and resisted simple LDA categorization. We speculate this may reflect effective use of slang terminology to clandestinely discuss drug-related activity. If so, straightforward analyses of digital drug-related communication may be more difficult than previously assumed. This work has the potential to be used for surveillance and detection of harmful drug use information. It also might be used for appropriate education and dissemination of information to persons engaged in drug use content on Twitter.

News (Medical) associated with Oxycodone Hydrochloride

28 Jun 2024

·www.drugs.com

Supreme Court Rejects Purdue Pharma Opioid Settlement

FRIDAY, June 28, 2024 -- The U.S. Supreme Court on Thursday struck down a controversial settlement that drug maker Purdue Pharma had reached with victims of the opioid epidemic. The ruling threatens a massive bankruptcy plan that would have protected the Sackler family, which controls the company, against future lawsuits in exchange for sending billions to opioid victims and states harmed by the crisis. Why did the court reject the settlement? In the 5-4 vote, the justices said the bankruptcy court lacked the authority to extend that protection to the Sackler family. “The Sacklers seek greater relief than a bankruptcy discharge normally affords, for they hope to extinguish even claims for wrongful death and fraud, and they seek to do so without putting anything close to all their assets on the table,” Justice Neil Gorsuch wrote in the court's majority opinion. “Describe the relief the Sacklers seek how you will, nothing in the bankruptcy code contemplates [much less authorizes] it.” But Justice Brett Kavanaugh noted in a dissent that the ruling will have a “devastating” impact. “As a result, opioid victims are now deprived of the substantial monetary recovery that they long fought for and finally secured after years of litigation,” he wrote in the dissent. The case dealt with the fate of Purdue Pharma and its leaders, who produced and promoted the opioid medication OxyContin in the early days of the opioid epidemic. In the settlement, the Sackler family had agreed to pay $6 billion to families and states as part of an agreement to wind down the company. In exchange, the Sackler family would be protected against future civil liability claims. Purdue first marketed Oxycontin as a safer, less addictive painkiller, encouraging doctors to prescribe the drug for longer periods of time and for more routine injuries. But a series of lawsuits claimed the family continued to promote Oxycontin even after it learned how addictive the drug really was. In a statement released after the ruling, Purdue Pharma said, “We are reaching back out to creditors and renewing our pursuit of a resolution that delivers billions of dollars of value for opioid abatement and allows the company to emerge from bankruptcy as a company with a public-minded mission." In a separate statement, the families of the late Mortimer Sackler and the late Raymond Sackler expressed disappointment with the decision, CNN reported. “The Sackler families remain hopeful about reaching a resolution that provides substantial resources to help combat a complex public health crisis,” the statement read. “The unfortunate reality is that the alternative is costly and chaotic legal proceedings in courtrooms across the country. While we are confident that we would prevail in any future litigation given the profound misrepresentations about our families and the opioid crisis, we continue to believe that a swift negotiated agreement to provide billions of dollars for people and communities in need is the best way forward.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Patent Infringement

27 Jun 2024

·www.fiercepharma.com

Billionaire Sackler family can't get legal immunity as part of Purdue bankruptcy deal, Supreme Court rules

Lawyers for Purdue and plaintiffs had spent years working toward a potential settlement. Now, the issue heads back to the bankruptcy court. Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court. Thursday, the high court blocked a multi-billion-dollar bankruptcy agreement for Purdue Pharma and its founding family, the Sacklers. Under the proposed deal, which was worth up to $10 billion, Purdue Pharma's founding family was set to return up to $6 billion to the company's bankruptcy estate in exchange for immunity from civil lawsuits related to the nationwide opioid crisis. As shown in the new Supreme Court opinion (PDF), various courts have issued contrasting outlooks on the immunity arrangement. A bankruptcy court originally approved the Purdue plan, but a District Court in late 2021 vacated the decision. In making that ruling, the U.S. District Court for the Southern District of New York held "that nothing in the law authorizes bankruptcy courts to extinguish claims against third parties like the Sacklers, without the claimants’ consent," according to the new SCOTUS document. Then, an appeals court reversed the District Court's ruling and revived the bankruptcy court's order for a modified reorganization plan. With those back-and-forth decisions, the Supreme Court was eventually left to decide on the closely watched case. Last summer, the Supreme Court put the deal on hold while it reviewed the case, as well as fresh arguments from the Biden administration. “In a 5-4 ideologically scrambled opinion, the court ruled that a bankruptcy settlement that proposed a release of all claims and future litigation against the owners of Purdue Pharma, who had not filed for bankruptcy themselves, was a bridge too far under the bankruptcy code,” John Richer from law firm Hall Estil said in written commentary on Thursday. The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong. The Sackler family secured more than $10 billion from Purdue Pharma, according to reports, even as the company's powerful painkiller OxyContin served as a driving force of the nationwide opioid epidemic. In the 20 years leading to 2019, nearly a quarter of a million people in the U.S. died from prescription opioid overdoses, according to the Supreme Court opinion. The Sacklers have all by now left Purdue's board and have not collected money from the company in several years.

Patent Infringement

15 Feb 2024

·www.biospace.com

Ensysce Biosciences Announces Publication of Clinical Bioequivalence Manuscript

Publication Details Positive Results of Clinical Study PF614-102 SAN DIEGO, CA / ACCESSWIRE / February 15, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC)(OTC PINK:ENSCW) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced online publication of its manuscript entitled, "Clinical evaluation of PF614, a novel TAAP(TM) prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers" published online by the open-access medical journal Clinical and Translational Science (CTS) sponsored by the American Society of Clinical Pharmacology and Therapeutics (ASCPT). The article is authored by members of the Ensysce team plus external experts; D. Lynn Kirkpatrick PhD, Cari Evans RN, Linda A. Pestano PhD, Jeffrey Millard PhD, Matthew Johnston MD, Emily Mick PharmD, and William K. Schmidt PhD. The results from the two-part PF614‑102 study are very significant as we believe they demonstrate a clear dose relationship between PF614 and oxycodone, which is the foundation for the FDA submission. The BE arm showed that plasma oxycodone bioequivalence was successfully achieved between 100 mg PF614 and 40 mg OxyContin. PF614 provided similar oxycodone exposures in both fasted and fed states, showing that it can be taken either on an empty stomach or with food, these data highlight PF614's potential advantage compared to other marketed abuse deterrent formulation (ADF) opioids. PF614 also showed a longer (12 hour) half-life, a major patient benefit in severe pain treatment. This manuscript provides a report of the safety and pharmacokinetics (PK) pro PF614, a Trypsin-Activated Abuse Protection (TAAP™) oxycodone prodrug designed to reduce recreational drug abuse. PF614 was compared to OxyContin® in healthy subjects in the initial multi-ascending dose arm of the study. Additionally, the manuscript details the second arm which evaluated oxycodone release from PF614 and OxyContin administered to 60 subjects in both a fasted and fed state in order to assess whether PF614 is bioequivalent (BE) to OxyContin. The notable distinction identified in this study between PF614 and OxyContin was the longer half-life of PF614, which provides a benefit to the patient as this is a true twice daily pain treatment. We believe this differentiating feature is critically important as steady blood levels can deliver sustained analgesia throughout the day to prevent breakthrough pain and the need for additional therapeutics. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, commented, "We are pleased that the PF614‑102 study not only confirmed findings from our prior Single Ascending Dose study showing 100 mg of PF614 releases oxycodone with a PK pro to 40 mg of OxyContin, but demonstrated the beneficial qualities of PF614 in contrast to alternative commercially available ADFs including its fed/fasted equivalency and longer half-life. As the clinical data and safety package strengthens for PF614 with each study we complete, we continue to move closer to our goal of bringing the ‘next generation' of analgesics for severe pain to market." CTS is a peer-reviewed open-access medical journal that highlights original research and helps to bridge laboratory discoveries with the diagnosis and treatment of human disease. About Ensysce Biosciences Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit . Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at . Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196 Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811 ENSC@mzgroup.us SOURCE: Ensysce Biosciences Inc. View the original press release on accesswire.com

Clinical ResultASCO

100 Deals associated with Oxycodone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00847	Oxycodone Hydrochloride	N02AA05	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Cancer Pain	JP	Shionogi Pharma Co., Ltd.	01 May 2012
Acute Pain	CN	Bard Pharmaceuticals Ltd.	21 Jan 2004
Chronic Pain	CN	Bard Pharmaceuticals Ltd.	21 Jan 2004
Pain	US	Roxane Laboratories, Inc.	26 Oct 1998

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2020	Not Applicable	Cancer Pain	51	体外高频热疗联合奥施康定	xklnnwhrtz(jfreiyhafl) = dmictkvifh zezgxqklmb (pxacqrptcd )	Positive	19 Sep 2020
				奥施康定	xklnnwhrtz(jfreiyhafl) = ruixintijw zezgxqklmb (pxacqrptcd )
CSCO2020	Not Applicable	Cancer Pain	108	盐酸羟考酮缓释片	gawxtbcwng(ygjewwvcfn) = pbgtifojqy ttjnqwhhbn (zgyxnmcodc )	Positive	19 Sep 2020
				盐酸羟考酮缓释片+针刺治疗	ququqdpnsu(nnxgyjkqvq) = mdigasiswv crgmytcqob (lyzxrgbekd ) View more
NCT01643772 (CTgov)	Phase 1	Pain	61	Oxycodone Hydrochloride (Oxycodone Hydrochloride Single Dose 5 mg)	ykxratbjjx(ftdvzgxcjc) = ikfzlpunmd nkwxximyix (mhbkwuzjup, erbvnezlsm - actirtqlby) View more	-	21 Oct 2019
				Oxycodone Hydrochloride (Oxycodone Hydrochloride Single Dose 10 mg)	ykxratbjjx(ftdvzgxcjc) = bdvpuzuyuy nkwxximyix (mhbkwuzjup, yrjtugvclt - akzvnxaedw) View more
NCT02660229 (CTgov)	Phase 4	Cancer Pain	66	Oxycodone Hydrochloride (Oxycodone Hydrochloride)	hhhvvjkrcd(tillwzsmxk) = qfndxftgjv dwgpgnmjra (iybivicmkw, dltxahjnei - dizsobhxye) View more	-	19 Nov 2018
				Morphine Sulphate (Morphine Sulphate)	hhhvvjkrcd(tillwzsmxk) = zcsolbcfev dwgpgnmjra (iybivicmkw, ogsmydcdxq - erapfaogoi) View more
NCT00654069 (CTgov)	Phase 3	Pain	405	Placebo (Placebo)	sphrrmhaau(zqvzksszom) = bmpshdntcp hkouzdbwko (emhvmybdnh, qrnthfbzff - wawjpuumzy) View more	-	22 Aug 2018
				Acurox 7.5/30 (Acurox 7.5/30)	sphrrmhaau(zqvzksszom) = lfbgajdgsi hkouzdbwko (emhvmybdnh, wfmosltsgt - vpuzibsvih) View more
NCT01115101 (CTgov)	Phase 4	Pain	239	Oral Oxycodon	xadgjcstey(bnmjruesrl) = hpphprfcvm iuoqztfivy (xlieiikfcc, dvpfwvwfxm - jxifcialwd) View more	-	15 Feb 2013
NCT00726830 (CTgov)	Not Applicable	Pain \| Myelodysplastic-Myeloproliferative Diseases \| Multiple Myeloma ... View more	1	methadone hydrochloride (Arm I: Opioid Rotation to Oral Methadone)	ghdgqhnivo(lzggerjjlb) = lbapuqarwk spgppmtalo (lqvwqrdbiq, rczebtcnfb - aicbjigvid) View more	-	06 Dec 2012
				oxycodone hydrochloride+morphine sulfate (Arm II: Opioid Rotation to Another Long-acting Strong Opioid)	ghdgqhnivo(lzggerjjlb) = cvwcabksaq spgppmtalo (lqvwqrdbiq, jtlxppsjxs - uvnsghxwre) View more
IAS2004	Not Applicable	Risk Reduction Behavior	100	Illicit OxyContin users	lmudzyancv(wonqnsnfuy) = cwrrvnptjp yjomgalcal (woqfexzevc ) View more	-	01 Jan 2004
				Non-users	lmudzyancv(wonqnsnfuy) = gqspobksoz yjomgalcal (woqfexzevc ) View more

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