An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics

The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.

开始日期2010-11-01

申办/合作机构

Purdue Pharma LP

ISRCTN76170309 / CompletedN/A

A randomised, crossover study of study drug 038 and controlled-release oxycodone HCl tablets in patients with chronic non-cancer pain

开始日期2008-07-31

申办/合作机构

Purdue Pharma Inc.

NCT01101308 / Completed临床1期

A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Wilson, NC Facility

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state.

开始日期2008-07-01

申办/合作机构

Purdue Pharma LP

100 项与盐酸羟考酮/烟酸相关的临床结果

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100 项与盐酸羟考酮/烟酸相关的转化医学

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100 项与盐酸羟考酮/烟酸相关的专利（医药）

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项与盐酸羟考酮/烟酸相关的文献（医药）

2023-08-01·Laryngoscope investigative otolaryngology

Opioid‐limiting legislation and prescribing habits of otolaryngologists among Medicare beneficiaries

Article

作者: West, Jonathan ; Hur, Kevin ; Kim, Ian ; Kim, Yun Ji ; Badash, Ido

Abstract:

Objectives:

To identify changes in otolaryngologists' opioid prescribing trends for Medicare beneficiaries associated with the enactment of state laws that limit the duration of prescriptions to 3–7 days in the years 2016 and 2017 in the United States.

Methods:

Through the Centers for Medicare and Medicaid Services (CMS) database, we retrieved data on Medicare enrollment and on the total days prescribed and total number of beneficiaries for the drugs codeine/acetaminophen, hydrocodone/acetaminophen, oxycodone HCl, oxycodone/acetaminophen, and tramadol HCl, by each otolaryngologist prescriber in 13 states from January 2013 to December 2019. We modeled trends using linear spline regression models that controlled for Medicare beneficiaries' state‐level socio‐demographic characteristics' fixed effects.

Results:

Across the 13 states, the number of days of all five opioids prescribed per beneficiary declined by 8.35 (SD = 12.61). The most commonly prescribed opioid type by otolaryngologists during the 5‐year study period was tramadol HCl (28.72 days/beneficiary) followed by oxycodone HCl (19.99 days/beneficiary). All opioids had declines in prescription days over this time window and higher rates of decline in the years following law passage. Four states experienced statistically significant declines in the prescriptions of all opioids after the year of legislation passage (p < .05). Some states that had the greatest inclines in opioid prescriptions in the years prior to law enactment also experienced the greatest reductions in the time after legislation enactment.

Conclusions:

Opioid prescribing practices of otolaryngologists may have been affected by opioid prescription duration limiting laws passed in 13 states in 2016 and 2017.

Level of Evidence:

Level 4.

2021-07-01·Pharmaceutical research3区 · 医学

Preferential Oxycodone Loss of Physically Manipulated Abuse Deterrent Oxycodone HCl Extended Release Tablets Prepared for Nasal Insufflation Studies

3区 · 医学

Article

作者: Raofi, Saeid ; Meng, Zhengjie ; Sun, Dajun ; Boyce, Heather J ; Kinjo, Minori ; Li, Tonglei

A method to reproducibly mill abuse deterrent oxycodone hydrochloride (HCl) extended release (ER) tablets was developed for a nasal insufflation pharmacokinetic (PK) study. Several comminution methods were explored before determining that a conical mill resulted in controlled milling of tablets to a size range equal to or below 1000 μm. However, milling resulted in significant loss of oxycodone from abuse deterrent oxycodone HCl ER tablets compared to minimal oxycodone loss from oxycodone HCl immediate release (IR) tablets. Characterization of milled tablet powder showed that loss of oxycodone was not attributed to analytical procedures or oxycodone phase change during high intensity milling processes. The content uniformity of oxycodone in the milled tablet powder varied when ER and IR tablets were milled to a particle size distribution equal to or below 500 μm but did not vary when particles were sized above 500 µm to equal to or below 1000 μm. In addition, the initial excipient weight to drug substance weight ratio impacted the amount of oxycodone lost from the respective formulation. However, dissolution demonstrated that when oxycodone HCl ER tablets are milled, differences in excipient weight to drug substance weight ratio and particle size distribution of milled tablets did not result in significantly different release of oxycodone.

2019-10-01·AAPS PharmSciTech3区 · 医学

Silk Fibroin as a Novel Alcohol-Resistant Excipient for Sustained-Release Tablet Formulation

3区 · 医学

Article

作者: Kozak, Jan ; Lamprecht, Alf ; Rabiskova, Miloslava

Concomitant intake of alcoholic beverages with sustained-release oral formulations may potentially lead to dose dumping. Alcohol-resistance testing is currently a requirement for the manufacturers by regulatory authorities. Silk fibroin produced by silkworm Bombyx mori is suggested in this work as a potential alternative to a narrow spectrum of alcohol-resistant excipients. Oxycodone HCl, tramadol HCl, and flurbiprofen were selected as model drugs and formulated with regenerated silk fibroin either in the form of an amorphous solid dispersion or as a physical mixture and compressed into tablets. Preliminary compactability and tampering-resistance studies were performed. The ethanol-resistance was tested in media containing 5%, 10%, 20%, or 40% (v/v) ethanol concentration. Drug release profiles were compared using f₂ similarity factor. Good mechanical tampering-resistance (tensile strength of 14.6 MPa at 400 MPa compression pressure) was obtained for tablets compressed from physical mixture. Tablets compressed from amorphous solid dispersion had lower tensile strength (2.2 MPa) but showed chemical tampering-resistance to extraction by pure ethanol (7.1% of oxycodone HCl after 24 h). Drug release is controlled predominantly by swelling and diffusion. With an increasing ethanol concentration in release medium, the tablets swelled less, resulting in a slower release. This trend was similar for all tested drugs and for both physical states formulations. No dose dumping occurred in the presence of ethanol; therefore, silk fibroin could be considered as an alternative alcohol-resistant excipient for sustained release application.

项与盐酸羟考酮/烟酸相关的新闻（医药）

2023-10-20

·FierceHealthcare

Pharmacies and wholesalers, not just PBMs, rely on spread pricing

Pharmacy benefit managers aren't the only ones using a tactic called spread pricing to earn profits. Of the $11.8 billion spent on 45 generic drugs by Medicare Part D in 2021, 70% went to intermediary gross profit, according to a new study. The analysis, which appeared in JAMA Health Forum Oct. 20, estimated Medicare Part D spent, on average, $22.50 per claim on generic drugs, resulting in a gross profit of $9.18 for pharmacy benefit managers, $3.87 for pharmacy gross profit, $2.71 wholesaler gross profit and $6.73 manufacturer revenue. It showed that many members of the pharmaceutical supply chain rely on spread pricing to earn profits, not just PBMs. Curbing spread pricing practices by PBMs has been a rare point of bipartisan consensus for lawmakers in Congress. Most recently, the Senate Finance Committee continued its barrage against PBMs in September, introducing the Modernizing and Ensuring PBM Accountability (MEPA) Act. Spread pricing was one of the major components of the bill, also discussed during a July markup hearing. The House unveiled its own legislation, which included a provision to ban spread pricing in Medicaid and to ban PBMs that contract with managed care organizations from utilizing spread pricing. Traditionally, PBMs will charge payers more for a drug than the amount a PBM pays a pharmacy and then keep the difference as a profit. “Policy efforts prohibiting spread pricing practice of PBMs may lower claim-level revenue retained by PBMs for generic drugs,” concluded the study’s authors. “However, absent sufficient market competition, PBMs may raise administrative fees to sustain revenue. Therefore it remains unclear how much spread pricing reform focused on PBMs alone would lower drug spending or strengthen the generic pharmaceutical supply chain.” Total intermediary gross profit ranged from -12.3% for oxycodone HCL at the low end to 88.6% for ezetimibe at the high end of Medicare Part D spending. The study’s authors said the analysis was limited by the “lack of information on direct and indirect remuneration offered by manufacturers or pharmacies,” making it impossible to estimate net profits generated. “Additionally, without access to the proprietary agreements between Centers for Medicare & Medicaid Services (CMS) and PBMs or plan sponsors, we were unable to determine what proportion of gross profits earned on generic drug transactions was returned to CMS or used to reduce premiums,” the study said, adding that the estimated PBM spread pricing may be underestimated.

2022-10-28

·BioSpace

Ensysce Biosciences Announces First Subjects Dosed in Second Human Abuse Potential Study

~ Critical Study to Support Abuse Deterrent Labeling ~ SAN DIEGO, CA / ACCESSWIRE / October 28, 2022 / Ensysce Biosciences Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety focused on reducing abuse and overdose, today announced the first subjects dosed in the PF614-104 study, ‘A Randomized, Double-blind, Placebo and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users' (ClinicalTrials.gov Identifier: NCT05571345). The study is being conducted by Drs. Brad Vince and Steven Hull at Dr. Vince Clinical Research (DVCR) in Overland, KS. This study is designed to test and confirm that oral PF614 will have less potential for ‘Drug Liking' by recreational drug users versus immediate release oxycodone at equivalent drug dosages. Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "This second Human Abuse Potential (HAP) study of PF614 is intended to demonstrate our technology's abuse deterrent properties and is critical for the ‘abuse deterrent' labeling of any new opioid drug product. This study along with our previous intranasal abuse liability study serve as important steps in establishing that PF614 may be differentiated from current immediate-release and extended-release oxycodone-containing products. PF614 uses the Ensysce TAAP™ technology and requires exposure to endogenous human trypsin in the intestines to trigger a two-step activation process to release active dose levels of oxycodone that is then absorbed systemically. Without exposure to trypsin, PF614 remains essentially inert and is excreted unchanged. This two-step activation is key to the abuse deterrence of PF614 and is ultimately what we believe sets PF614 apart from current marketed opioids. Our focus is on aiding those suffering from severe pain while reducing the fear of opioids." The PF614-104 study will examine the desirability of three doses of PF614 versus a currently marketed dose of oxycodone HCl and versus placebo in recreational drug users. Eligible subjects will receive five treatments (one per treatment period) in a randomized, double-blind, crossover manner. The primary outcome measure will be ‘Drug Liking' and the key secondary endpoint will be ‘Take Drug Again.' Dr. Lynn Kirkpatrick, CEO of Ensysce offered, "This study is vital to our path to commercialization, and we are extremely happy to be working with DVCR to execute this study. We believe that PF614 is a unique drug in the opioid space and this study may provide data that further supports its potential. We look forward to completing this study and reporting the data, expected in early 2023." About Ensysce Biosciences Ensysce Biosciences is a clinical-stage biotech 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 in the process of developing a unique, tamper-proof treatment option for pain that minimizes the risk of both drug abuse and overdose. Our products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse, reducing the human and economic costs. 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," and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinical development and are 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 annual report on Form 10-K 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 source version on accesswire.com:

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100 项与盐酸羟考酮/烟酸相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
疼痛	申请上市	美国	Acura Pharmaceuticals, Inc.	-
疼痛	申请上市	-	Pfizer Inc.	-
阿片相关性障碍	临床2期	美国	Acura Pharmaceuticals, Inc.	2008-03-01