Delving into the Latest Updates on Tramadol Hydrochloride/Acetaminophen with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Paracetamol and Tramadol Hydrochloride, Tramadol Hydrochloride Paracetamol, Tramadol/Paracetamol

+ [15]

Target

COXs x μ opioid receptor

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

PainCancer PainAcute Pain

Inactive Indication

Ankle InjuriesChronic PainLow Back Pain+ [4]

Originator Organization

Ortho-McNeil Pharmaceutical LLC

Active Organization

Janssen Pharmaceutical KK

Xian-Janssen Pharmaceutical Ltd.

Aspen Pharmacare Australia Pty Ltd.

Inactive Organization

Janssen Pharmaceuticals, Inc.

Janssen Korea Ltd.Johnson & Johnson Pharmaceutical Research & Development LLC

License Organization

Spektus Pharma, Inc.Gebro Holding GmbH

Drug Highest PhaseApproved

First Approval Date

United States (15 Aug 2001),

Acute Pain

Regulation-

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Structure/Sequence

Molecular FormulaC24H35ClN2O4

InChIKeyUFLWHLMSTCRAJP-WUTOMRCLSA-N

CAS Registry147630-10-2

Author: Yamashita, Toshihiko ; Haro, Hirotaka ; Matsuyama, Yukihiro ; Yoshida, Munehito ; Mochida, Joji ; Inoue, Gen ; Kaito, Takashi ; Taneichi, Hiroshi ; Iwasaki, Motoki ; Shintani, Ayumi ; Takura, Tomoyuki ; Miyakoshi, Naohisa ; Yamazaki, Masashi ; Murakami, Hideki ; Takahashi, Kazuhisa ; Kawakami, Mamoru ; Kabata, Daijiro ; Ito, Manabu ; Taguchi, Toshihiko ; Yamada, Hiroshi ; Ohtori, Seiji ; Nishida, Kotaro ; Imagama, Shiro ; Yonenobu, Kazuo

BACKGROUND:

Chronic low back pain (CLBP) is a major cause of chronic pain with nociceptive, neuropathic or both pain components, and a leading cause of disability. The objectives of this study were to determine the impact of background factors including previous use of drugs on outcomes of pharmacological therapy for CLBP in a nationwide multicenter prospective study.

METHODS:

The subjects were 474 patients (male: 41.9%, median age: 73.0) with CLBP. Background factors that could influence outcomes after pharmacological treatment for 6 months were examined: age, gender, body mass index (BMI), duration of CLBP, osteoporosis, history of spinal surgery, history of malignant tumor, smoking habit, employment status (yes or no), exercise habit (frequency), number of live-in family members, having something to do for pleasure, Center for Epidemiologic Studies depression scale (CES-D) score, and medication at baseline. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) for LBP, JOA Back Pain Evaluation Questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire (RDQ), Short-form 8-item health survey (SF-8), and EQ-5D were used for evaluation at baseline and after 6 months. Multivariate linear regression models were used in statistical analysis.

RESULTS:

Drugs for neuropathic pain at baseline (p < 0.001), Tramacet® at baseline (p < 0.05), weak opioids at baseline (p < 0.05), older age (p < 0.001), long disease duration (p < 0.005), history of spinal surgery (p < 0.001), and smoking habit (p < 0.001) had significant negative effects on outcomes. Employment (p < 0.05), exercise habit (p < 0.05), and CED-D at baseline (p < 0.001) had positive effects on outcomes.

CONCLUSIONS:

This is the first study to identify significant prognostic factors for outcomes of pharmacological treatment of CLBP. The neuropathic pain component of CLBP at baseline is a major significant negative factor for most outcomes involving improved pain, activities of daily life, and quality of life. Treatment strategies developed with consideration of these factors may be advantageous for recovery from CLBP.

01 Dec 2020·Traditional & Kampo Medicine

An effective case of shichimotsukokato treatment for postherpetic neuralgia in a patient with chronic kidney disease

Author: Fujii, Tomoaki ; Morimoto, Yuji

ABSTRACT:

Case:

A 78‐year‐old female who had chronic kidney disease developed postherpetic neuralgia. She was prescribed several analgesics, but the pain was severe.

Outcome:

Shichimotsukokato was prescribed to this patient, and her pain was gradually relieved. During the course of treatment, the pain worsened when tramadol hydrochloride acetaminophen tablets were interrupted and improved upon their resuming their administration, suggesting an effect for the combination with shichimotsukokato. Her renal function did not worsen, but rather seemed to have improved.

Conclusion:

Analgesics can be inappropriately used in patients with chronic kidney disease. For chronic kidney disease patients with postherpetic neuralgia, shichimotsukokato may have an effect on both pain and renal function and seems to be beneficial.

1

News (Medical) associated with Tramadol Hydrochloride/Acetaminophen

03 Nov 2026

·www.biospace.com

Spektus Pharma and GEBRO Holding Announce Global Commercialization Partnership for ActraFlex®

Novel twice-daily extended-release tramadol/paracetamol formulation combines Spektus' proprietary AmyloFlex® technology with GEBRO's established Diliban® brand. LAVAL, QC and FIEBERBRUNN, Austria , Nov. 3, 2026 /PRNewswire/ -- Spektus Pharma Inc. ("Spektus") and GEBRO Holding GmbH ("GEBRO") today announced a strategic global commercialization partnership for ActraFlex®, a novel twice-daily extended-release formulation of tramadol and paracetamol for pain management. ActraFlex® combines Spektus' patented AmyloFlex® drug-delivery technology with GEBRO's established Diliban® product, creating a differentiated formulation designed to provide sustained drug release with convenient twice-daily dosing. Under the partnership, GEBRO will lead commercialization and supply across Europe and selected international markets, anchored by Spain, where Diliban® has an established commercial presence. Spektus will lead commercialization and supply across the Americas and selected markets in Africa and Asia through its network of regional pharmaceutical partners. "Our partnership with GEBRO highlights the potential of Spektus' proprietary AmyloFlex® technology to create differentiated specialty medicines from established products and brands. Building on GEBRO's successful commercialization of Diliban® in Europe, we see strong commercial potential for ActraFlex® across the Americas, Africa and Asia," said Zarvaan Merchant, CEO of Spektus Pharma. "GEBRO brings deep expertise in pain management and a strong foundation with Diliban® in Europe. Together with Spektus' established commercialization partner network, we believe ActraFlex® has the potential to become an important global product in pain management," said Christian Kollenz, Managing Director of GEBRO Holding. The companies will lead regulatory approvals and commercialization in their respective territories. Financial terms were not disclosed. About Spektus Pharma Spektus Pharma Inc. is a Canadian specialty pharmaceutical company focused on developing and commercializing differentiated medicines using proprietary drug-delivery technologies. Spektus applies its formulation platforms to established active pharmaceutical ingredients and products to create differentiated therapies addressing unmet patient and market needs. Through an established network of pharmaceutical partners, Spektus is advancing the commercialization of its portfolio across North America, Europe and international markets. About GEBRO Holding GEBRO Holding GmbH is an Austrian pharmaceutical company with extensive experience in the development and commercialization of specialty pharmaceutical products, with a particular focus on pain management and rheumatoid arthritis. Headquartered in Fieberbrunn, Austria, GEBRO operates across multiple European and international markets through own affiliates or through its partner network. Media Contacts Spektus Pharma Inc. info@spektuspharma.com GEBRO Holding GmbH pharma@gebro.com View original content to download multimedia: SOURCE Spektus Pharma

100 Deals associated with Tramadol Hydrochloride/Acetaminophen

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External Link

KEGG	Wiki	ATC	Drug Bank
D09999	-	N02AJ13	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain	Australia	Aspen Pharmacare Australia Pty Ltd.	19 Mar 2012
Cancer Pain	Japan	Janssen Pharmaceutical KK	22 Apr 2011
Acute Pain	United States	Janssen Pharmaceuticals, Inc.	15 Aug 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Low Back Pain	Phase 3	-	Janssen Korea Ltd.	01 May 2009
Chronic Pain	Phase 3	Japan	Janssen Pharmaceuticals, Inc.	01 May 2008
Pain, Postoperative	Phase 3	Japan	Janssen Pharmaceuticals, Inc.	01 Mar 2008
Ankle Injuries	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Musculoskeletal Pain	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Sprains and Strains	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Osteoarthritis, Knee	Phase 2	-	Janssen Pharmaceuticals, Inc.	01 Jun 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05406752 (CTgov)	Phase 1	Acute Pain	32	paracetamol Uniflash (125 mg/ 1.25 mL)	xbzncwusny(xpesgsgrws) = vgwaofanpi qadzircdbn (lclxuiwcqj, 1148.85) View more	-	13 Dec 2024
WCO_IOF_ESCEO2018	Not Applicable	Osteoarthritis, Knee	48	Tramadol/Acetaminophen	uorzprkdqf(gxxfnygemu) = gxsgupdimj dlltynrxwd (ticmltyrof ) View more	Positive	27 Jul 2018
WCO_IOF_ESCEO2018	Not Applicable	Osteoarthritis, Knee	48	NSAID (Naproxen 500mg)	uorzprkdqf(gxxfnygemu) = fmghsnsphc dlltynrxwd (ticmltyrof ) View more	Positive	27 Jul 2018
NCT02389361 (CTgov)	Phase 4	Hernia, Inguinal \| Pain, Postoperative	51	Zaldiar (Group Z)	lxmscmqdkr(chjhqwsudy) = sppggfiuny leqldyhqrp (aybksgwwjs, 1.28) View more	-	13 Aug 2015
NCT02389361 (CTgov)	Phase 4	Hernia, Inguinal \| Pain, Postoperative	51	Paracetamol-Tramadol (Group PT)	lxmscmqdkr(chjhqwsudy) = tbodgcdmcx leqldyhqrp (aybksgwwjs, 1.86) View more	-	13 Aug 2015
NCT01345162 (PTSM04APHP, CTgov)	Phase 4	Hernia	200	intraoperative analgesia+Ketorolac postoperative	pbgrufpnjp = ncxvkfxfor xhatfxgwzi (chexszxkhn, kcdvunmneg - ibvlgpufkt) View more	-	09 Jun 2014
NCT00736853 (CTgov)	Phase 3	Chronic Pain	321	Placebo (Double-Blind)	tmsrvuxkgb = ulwgwcesri riioxkazzf (aeefohtomb, mzuruiruaj - euvyftcbpy) View more	-	26 Sep 2013
NCT01843660 (CTgov)	Phase 4	Low Back Pain \| Shoulder Pain \| Acute Pain ... View more	1,059	Tramadol HCl-Paracetamol	acivcgbnij(bhyqdljgpk) = xfwpyuxfej vhwtfqsmcm (nxmuvtzygg, 2.07) View more	-	26 Aug 2013
NCT00737048 (CTgov)	Phase 3	Pain, Postoperative	328	Placebo+Acetaminophen	kemujzrbxj(raphhpbely) = ixijlqrjdn qfekvlecux (kkpnoqjlme, 8.07) View more	-	01 Aug 2013
NCT01112267 (CTgov)	Phase 3	Low Back Pain	248	Placebo	ucryoihtxs = qdgiembiqq dovczrhzxa (udulbpnazp, tysberjmri - cabezuoogz) View more	-	24 Jul 2013
NCT00634543 (CTgov)	Phase 4	Diabetic Neuropathies \| Diabetic peripheral neuropathic pain	162	Gabapentin	ayvadfwjur(btkxlxkybi) = cpbridqjrn klxswhxmxm (oxzikhwoxh, 1.58) View more	-	16 Jul 2013
NCT00635349 (CTgov)	Phase 4	Osteoarthritis, Knee	143	Tramadol Hydrochloride Plus Acetaminophen+Aceclofenac+Meloxicam	ypdavgalyd(byeswoxmev) = vacfcnwswr ygrxszppuq (xhryfyjmjj, 14.17) View more	-	24 Jun 2013