Delving into the Latest Updates on Acetaminophen/Oxycodone with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

LTX-02, Percoset

Target

COXs x Opioid receptors

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), Opioid receptors agonists(Opioid receptors agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Acute Pain

Inactive Indication-

Originator Organization-

Active Organization-

Inactive Organization

Acura Pharmaceuticals, Inc.Abuse Deterrent Pharma LLC

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC18H21NO4

InChIKeyBRUQQQPBMZOVGD-XFKAJCMBSA-N

CAS Registry76-42-6

View All Structures (2)

Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction.
Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively.
Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.

Start Date11 Feb 2020

Sponsor / Collaborator

The Methodist Hospital Research Institute

100 Clinical Results associated with Acetaminophen/Oxycodone

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100 Translational Medicine associated with Acetaminophen/Oxycodone

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100 Patents (Medical) associated with Acetaminophen/Oxycodone

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1

Literatures (Medical) associated with Acetaminophen/Oxycodone

20 Oct 2015·JAMAQ1 · MEDICINE

Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain

Q1 · MEDICINE

Article

Author: Davitt, Michelle ; Bijur, Polly E. ; Holden, Lynne ; Dym, Andrew A. ; Solorzano, Clemencia ; Esses, David ; Gallagher, E. John ; Friedman, Benjamin W.

IMPORTANCE:

Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination.

OBJECTIVE:

To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen.

DESIGN, SETTING, AND PARTICIPANTS:

This randomized, double-blind, 3-group study was conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014.

INTERVENTIONS:

All participants were given 20 tablets of naproxen, 500 mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5 mg; or oxycodone, 5 mg/acetaminophen, 325 mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge.

MAIN OUTCOMES AND MEASURES:

The primary outcome was improvement in RMDQ between ED discharge and 1 week later.

RESULTS:

Demographic characteristics were comparable among the 3 groups. At baseline, median RMDQ score in the placebo group was 20 (interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20 (IQR,17-22). At 1-week follow-up, the mean RMDQ improvement was 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 (98.3% CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3% CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine, 0.9 (98.3% CI, -2.1 to 3.9; P = .45).

CONCLUSIONS AND RELEVANCE:

Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01587274.

100 Deals associated with Acetaminophen/Oxycodone

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	N02AJ17	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Pain	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Preclinical	United States	Acura Pharmaceuticals, Inc.	14 Jun 2021
Pain	Preclinical	United States	Abuse Deterrent Pharma LLC	14 Jun 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04246554 (CTgov)	Phase 3	Pain, Postoperative \| Anterior Cruciate Ligament Injuries	49	Oxycodone-Acetaminophen (Control)	rshanxqolb(umndechabl) = ahmcdsyvru uksefnfcgo (quupbvexrg, 5.3) View more	-	21 Dec 2021
				Ketorolac (Ketorolac)	rshanxqolb(umndechabl) = ojhbzlzndz uksefnfcgo (quupbvexrg, 4.9) View more
NCT04194528 (S1916, CTgov)	Not Applicable	Pain \| Neoplasm Metastasis	2	Proteus digital medicine program+Oxycodone/acetaminophen 5/325 mg	yelgygbgzm = pvbttxonho nhqelvpyfj (lhkuwjcouj, hjkpqyodqh - ocapczzxmp) View more	-	10 Dec 2021
NCT04246541 (CTgov)	Phase 3	Postoperative Complications \| Drug-Related Side Effects and Adverse Reactions \| Pain, Postoperative ... View more	48	Oxycodone-Acetaminophen (Control)	gpsieheuhm(huzjjvobuy) = ejmtwwyzoj ciunfqqojf (iungdegazn, 22.7) View more	-	01 Dec 2021
				Ketorolac (Ketorolac)	gpsieheuhm(huzjjvobuy) = hfwunmctjw ciunfqqojf (iungdegazn, 26.3) View more
NCT04399122 (CTgov)	Phase 4	Pain, Postoperative	200	acetaminophen/codeine vs acetaminophen/oxycodone (Acetaminophen With Codeine)	pjkjmljcpj(epjpgflrfy) = xjnerxnofp rpbxvslqyp (qnjvtzizop, 2.03) View more	-	05 Oct 2021
				acetaminophen/codeine vs acetaminophen/oxycodone (Acetaminophen With Oxycodone)	pjkjmljcpj(epjpgflrfy) = ogmljmpkga rpbxvslqyp (qnjvtzizop, 2.29) View more
NCT02480114 (CTgov)	Phase 3	Mucositis \| Radiodermatitis \| Head and Neck Neoplasms	79	Hydrocodone/Acetaminophen+Pain Therapy+Fentanyl+Ibuprofen+Oxycodone/Acetaminophen (Arm I Standard of Care)	wzqegitibx(psmewddfjn) = kfejtyzqxs dcmcsdexui (jkgvfawljd, pjalrqszyk - fwcemhlodf) View more	-	24 Sep 2020
				Hydrocodone/Acetaminophen+Pain Therapy+Fentanyl+Ibuprofen+Gabapentin+Oxycodone/Acetaminophen (Arm II Standard of Care Plus Gabapentin)	wzqegitibx(psmewddfjn) = gfhnnbhqwl dcmcsdexui (jkgvfawljd, vcseequcfm - tjrvgqwrnm) View more
NCT01587274 (CTgov)	Phase 4	Acute low back pain	323	Naproxen+Oxycodone/ acetaminophen (Opioid)	jhcfxyaijy(vdwcntpncm) = iflzxfgmpn chikdygseq (olgauopprv, rzxkzqqohf - diatorfmtx) View more	-	31 Jul 2018
				Naproxen+Cyclobenzaprine (Skeletal Muscle Relaxant)	jhcfxyaijy(vdwcntpncm) = hmzznyjvep chikdygseq (olgauopprv, odnlpmhjmt - kijsqxhgkr) View more
NCT02455518 (CTgov)	Phase 4	Musculoskeletal Pain	416	Oxycodone/acetaminophen (Oxycodone/Acetaminophen)	mmyhbwavip = owcwkpqzse hahmmpapbh (ljxjuwdizi, zkwrvfjttc - hwwpgjbdue) View more	-	13 Feb 2018
				Hydrocodone/acetaminophen (Hydrocodone/Acetaminophen)	mmyhbwavip = hrlxieifvi hahmmpapbh (ljxjuwdizi, xnjvpvuxgs - slbhdjtipe) View more
NCT01587274 (Pubmed \| JAMA)	Phase 4	Acute low back pain	323	Naproxen + Placebo	penuqknlmp(aijejukwol): P-Value = 0.3	-	20 Oct 2015
				Naproxen + Cyclobenzaprine
ASCO2010	Not Applicable	Ostealgia	86	Oxycodone 5 mg/Acetaminophen 325 mg combination tablet	mphltblwhf(upstovbpqr) = utohyqjbpr pkjjwnrgaz (grimytjyde )	Positive	20 May 2010
				Placebo	mphltblwhf(upstovbpqr) = bxlqbtmdew pkjjwnrgaz (grimytjyde )