Delving into the Latest Updates on Tramadol Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Abidol, Tramadol, Tramadol hydrochloride (JP17/USP)

+ [64]

Target

NET x μ opioid receptor

Action

inhibitors, agonists

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Chronic PainPainCancer Pain+ [1]

Inactive Indication

Low Back PainOsteoarthritis, KneePremature Ejaculation

Originator Organization

Johnson & Johnson

Active Organization

Grünenthal GmbH

Duoduo Pharmaceutical Co. Ltd.

Cipher Pharmaceuticals, Inc.

+ [4]

Inactive Organization

Bausch Health Americas, Inc.

Purdue Pharma LP

Janssen Pharmaceuticals, Inc.

+ [5]

License Organization

Fortress Biotech, Inc.Mundipharma KK

Revogenex Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

Japan (10 Mar 1978),

Cancer PainPain, Postoperative

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC16H26ClNO2

InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N

CAS Registry36282-47-0

Two-year observational and cross-sectional study (January 2020 - December 2021) was conducted in 75 community pharmacies from Catalonia. To estimate the potential abuse and misuse of tramadol by patients visiting community pharmacy, and to establish the demographic characteristics of the tramadol users, a validated questionnaire based on the Finch criteria was designed. A total of 251 cases were registered.

Results:

Data show that women were more involved (56.6%) and the highest proportion was found in the age interval of 46-65 years (42.6%). The combination of tramadol and paracetamol was reported in 54.6% of the cases and 73.7% corresponded to immediate-release tablets. In 93.6% of the cases, the request was preceded by previous use. Conversely, young men showed a higher non-prescription request for tramadol, reporting acute pain (p < 0.05). These results indicate that there is non-therapeutic use among patients who visit community pharmacies for information on two profiles.

Conclusion:

This study shows that being an aged woman and suffering from chronic pain seems to involve a risk of generating dependence on tramadol. Likewise, a suspicion of recreational use of tramadol by young people has also been identified. There is a need to investigate how to manage chronic pain, given its complexity and take into account the risk of misuse that may come with tramadol. The involvement of characteristics such as gender as well as the pharmaceutical form in the development of tramadol misuse also needs to be analysed deeply. It is mandatory to evaluate the criteria for prescribing tramadol and initiatives to improve the knowledge of the health professionals and the population.

01 Sep 2025·TALANTA

SERS detection of analgesics in serum based on Ag nanocubes for perioperative monitoring

Article

Author: Qin, Lei ; Ji, Yinghe ; Han, Lin ; Wu, Jing ; Wang, Yunpeng ; Zhu, Zhuo ; Li, Yang ; Sun, Tingting

Prompt and personalized perioperative analgesia management relies on sensitive and convenient monitoring of analgesics. We report a strategy for sensitive and reproducible SERS detection of analgesics based on Ag nanocubes, which have abundant intragranular hot spots on sharp corners and interparticle hot spots between gaps. Both theoretical simulations and R6G detection experiments indicated that the enhancement factor of Ag nanocube SERS platform reach to 10⁶ level. Quantitative and reproducible determination capabilities of this platform for six different analgesics with LOD as low as 500 pg mL^-1 were verified. Pharmacokinetic experiment of fentanyl in rat serum samples by SERS detection within 4 h presented consistent results with the UHPLC-MS/MS method. Valid examples of SERS detection for single or multiple analgesics in clinical patients' serums further proved the feasibility of this platform for perioperative analgesic monitoring.

01 Sep 2025·AQUATIC TOXICOLOGY

Contamination of water with drugs - the response of phytoplankton

Article

Author: Krawczyk, Barbara ; Kaźmierczak, Andrzej ; Czarny-Krzymińska, Karolina ; Szczukocki, Dominik

Human xenobiotic emissions exert a notable effect on aquatic organisms. However, there is a paucity of information concerning the chronic effects of drugs on aquatic microorganisms. Furthermore, the majority of studies to date have considered the toxicity of individual compounds in isolation rather than in complex mixtures found in the environment. The present investigation sought to assess the chronic impact of amoxicillin, bisoprolol, diclofenac, ketoprofen, sulfadiazine, and tramadol on three species of aquatic primary producers: Chlorella vulgaris, Desmodesmus armatus, and Trichormus variabilis for both individual compounds and their mixture. The obtained findings demonstrated significant inhibition of the growth of all tested strains, alteration in antioxidant enzyme activity, and morphological changes in their cells. The nature of the effects of the compounds in the tested mixture was additive. Furthermore, the ecological risk associated with exposure to the tested substances was assessed. The risk was determined to be high for ketoprofen and drugs mixture, medium for amoxicillin, diclofenac, and sulfadiazine, and low for bisoprolol and tramadol. The results of this study have revealed the ecotoxicological risks posed by the tested drugs to photosynthetic microorganisms, and have also offered insights into the biochemistry and cell morphology of the microorganisms in question. In addition, the findings of this study indicate that the exclusive reliance on the EC₅₀ parameter in the evaluation of the impact of xenobiotics on non-target organisms represents a remarkably constrained approach. This is attributable to the fact that it fails to provide insight into the changes that occur at the cellular level.

84

News (Medical) associated with Tramadol Hydrochloride

12 Jun 2025

·pipelinereview.com

Tris Pharma to Debut Positive Results of Intranasal (Snorting) Human Abuse Potential Study of Cebranopadol, an Investigational First-In-Class Oral Dual-NMR Agonist for the Treatment of Moderate-to-Severe Pain, at the 2025 CPDD Annual Meeting

– Study met primary endpoint demonstrating cebranopadol is significantly less likely to be misused intranasally (snorting) than oxycodone with majority of recreational opioid users indicating no desire to take cebranopadol again – – Results are similar to previously announced human abusability data from oral administration of cebranopadol compared to oxycodone (Schedule II) and tramadol (Schedule IV) – – Together these studies suggest that cebranopadol may have a significantly lower risk of abuse – MONMOUTH JUNCTION, NJ, USA I June 12, 2025 I Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced that the company will present intranasal human abusability datafrom cebranopadol, an investigational first-in-class oral dual NOP/MOP (dual-NMR) agonist, at the College on Problems of Drug Dependence (CPDD) Annual Meeting, taking place June 14-18, 2025, in New Orleans. The data will be presented in a late-breaking oral session and a poster presentation which highlight the significantly lower abuse potential of cebranopadol compared to established opioids such as oxycodone (Schedule II) and tramadol (Schedule IV). The late-breaking oral session will highlight positive results from an intranasal human abuse potential study demonstrating that snorting cebranopadol was significantly less liked compared to oxycodone. These results expand on an earlier study that demonstrated cebranopadol has significantly less oral abuse potential than oxycodone (Schedule II) and tramadol (Schedule IV). The poster presentation summarizes all key data to date that characterize the low abuse potential of cebranopadol. Overall, these studies support the novel mechanism of action of cebranopadol, where NOP receptor activation minimizes the potential abusability associated with MOP receptor agonists. “These results demonstrate the potential of cebranopadol, and likely other dual-NMR agonists, to change how we treat pain while reducing the risk of misuse,” said Ketan Mehta, founder and CEO at Tris Pharma. “We continue to believe in the promise of cebranopadol to transform the lives of patients with moderate-to-severe pain as evidenced by data that show strong efficacy as well as significantly lower abusability than existing options.” “The dangerous practice of crushing and insufflating opioids, often a progression from recreational use and a precursor to the use of more potent substances, underscores the critical need for analgesic alternatives with reduced potential for misuse,” said Megan Shram, Ph.D., an expert on human abuse potential studies. “This research indicates that cebranopadol exhibits a distinct pharmacological profile compared to conventional opioids such as oxycodone, and neither the oral nor intranasal administration of cebranopadol has demonstrated the capacity to produce reinforcing (i.e., euphoric) effects typically observed with high abuse liability opioids. These findings suggest that the treatment of pain with cebranopadol may offer an improved public health safety profile and more favorable risk-benefit ratio compared to traditional opioid analgesics.” Tris Pharma Presentations Poster Presentation Late-Breaking Oral Session Grant Funding Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG3DA059285. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About Acute Pain Acute pain affects millions of patients each year and is caused by injury, surgery, illness, trauma, burns or painful medical procedures, which can last up to three months, and typically resolves once the underlying cause is treated or healed. Moderate-to-severe acute pain can often only be effectively treated with conventional opioid analgesics such as oxycodone, especially following joint replacements and other orthopedic procedures, invasive surgeries, and major traumas and burns. About Cebranopadol (TRN-228) Cebranopadol is a first-in-class investigational therapy that targets two key receptors, the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors (a dual-NMR agonist), for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). These receptors are partially homologous to each other, and they play both complementary and distinct roles to modulate pain biology pathways. Studied in over 33 clinical trials in more than 2,200 patients, cebranopadol’s profile has been well characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain, and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it could become the first dual-NMR pain-relief therapy with the demonstrated ability to provide efficacy similar to conventional opioids with less potential for misuse or risk of physical dependence, addiction or overdose. Cebranopadol’s novel mechanism of action has potential in treating patients with substance use disorders (SUDs). Tris plans to continue to evaluate cebranopadol’s potential to help patients break the cycle of opioid addiction. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol’s potential to treat OUDs and SUDs. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris markets a portfolio of best-in-class ADHD products and is developing a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @ TrisPharma . SOURCE: Tris Pharma

Clinical ResultFast Track

08 May 2025

·firstwordpharma.com

Viatris plans year-end FDA filing for fast-acting pain drug

Viatris said Thursday it is looking to file for FDA approval by year-end after its rapid-onset meloxicam candidate — dubbed MR-107A-02 — succeeded in two Phase III studies involving patients recovering from hernia repair or bunion surgeries.Its formulation of the commonly used non-steroidal anti-inflammatory drug demonstrated statistically significant pain reduction across both acute pain models while also showing significant decreases in opioid use compared to placebo."Building on an established mechanism of action and well-characterised safety profile, the efficacy and benefit-risk profile observed in these two pivotal studies optimally positions our fast-acting meloxicam for potential first-line treatment of moderate-to-severe acute pain," commented Chief R&D Officer Philippe Martin.According to Viatris, patients treated with MR-107A-02 reported significantly more pain relief from baseline over 48 hours compared to placebo, measured using Sum of Pain Intensity Difference (SPID0-48h). After herniorrhaphy, the mean improvement in pain scores was 50.1 points higher for MR-107A-02; and following bunionectomy, the difference was even greater — an average of 82.7 points.In addition, 72.6% of the hernia patients and 56.9% of bunion patients treated with MR-107A-02 remained opioid-free over the entire treatment phase, compared to placebo rates of 58.6% and 33.1%, respectively.Both studies also included an opioid comparator arm — tramadol given every six hours — to confirm the sensitivity of the pain model. Viatris said post-hoc analyses showed that MR-107A-02 provided "superior pain control" over 48 hours than tramadol in both types of surgery, and was either faster or on par with the widely used opioid drug in terms of the time it took to achieve perceptible or meaningful pain relief.Companies have been trying to address the US opioid crisis with effective alternatives. Vertex Pharmaceuticals' non-opioid pain medication Journavx (suzetrigine), which received FDA approval at the end of January, is a recent entrant in the space. Earlier this week, Vertex reported only nominal first-quarter revenue for Journavx, which works by blocking NaV1.8 voltage-gated sodium channels, but company officials said the drug had racked up about 25,000 prescriptions as of April 25."Although it's early days, we're seeing tremendous receptivity to a novel non-opioid option for the treatment of moderate to severe acute pain," said Duncan McKechnie, Vertex's soon-to-be chief operating officer, during the company's earnings call (see – Spotlight On: Vertex plots $1B+ sales trajectories for Casgevy, Journavx).Meanwhile, Viatris reported that MR-107A-02 was generally well tolerated, with treatment-emergent adverse events comparable to placebo and "few" severe adverse events. The company plans to present full results from both Phase III trials at upcoming medical conferences, including the PAINWeek conference in September, as it prepares its FDA submission based on the two post-op studies as well as earlier Phase II dose range finding data in dental pain.

Clinical ResultPhase 3Phase 2

08 May 2025

·www.biopharmadive.com

Viatris’ new form of old pain drug scores in large trials

Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug its been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year.The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, acute pain felt after an injury or operation. Researchers evaluated the drug in a dental pain study in 2022. Not long after, a pair of late-stage clinical trials began assessing it in nearly 1,000 people who had just undergone either a bunion removal or a hernia repair surgery.Results from those trials, according to Viatris, now show that pain scores improved substantially more for participants given the drug rather than a placebo. The main goal of both experiments revolved around a scoring system that measures pain intensity over a two-day period. Its the same system Vertex Pharmaceuticals used in the studies that ultimately led to the approval of Journavx, a closely watched, non-opioid pain reliever.Viatris, like Vertex, also set up arms in its trials to compare the relief provided by its drug to that of an opioid. The company said after-the-fact analyses found the drug offered significantly superior pain control to tramadol. The amount of time it took for participants to sense some pain reduction and to classify that reduction as meaningful was also comparable between the two groups and, in some cases, shorter for those on Viatris therapy.Journavx did not significantly outperform the opioid arms in Vertexs studies, though those used a combination of Tylenol and a more potent opioid, hydrocodone.Additionally, Viatris said that during the main treatment phase of its studies, there was a notable reduction in opioid usageas well as a higher number of opioid-free patients in the drug group as opposed to the placebo group. Patients also generally tolerated the drug well. There were few so-called severe treatment emergent adverse events, and the incidence of them was comparable across the two groups.All this evidence optimally positions Viatris drug to become a first-line treatment for moderate-to-severe acute pain, according to Philippe Martin, the companys research and development head. “The data observed ... is a critical step in the development of a safe and effective non-opioid option to address an important public health need, he said in a statement.The trial results were released alongside Viatris first quarter earnings report. The company, which officially formed in 2020, when Mylan merged with Pfizers Upjohn unit, recorded $3.3 billion between January and March, an 11% decrease from the same period a year prior. Viatris shares were up over 10% late Thursday morning, to trade around $9.48 apiece.Shares of Vertex, meanwhile, were down more than 2%, capping off a week in which the company lost tens of billions of dollars in value thanks, in part, to an earnings report that disappointed investors.Michael Yee, a Jefferies analyst who covers Vertex, wrote in a note to clients that first quarter revenue and earnings per share were light. But what stood out was the company saying Journavx revenue was “insignificant during the period, even though cumulative prescriptions had grown to around 25,000 by late April.Brian Skorney, a Baird analyst who also follows Vertex, wrote in his own note that the new Viatris data highlight a number of concerns we have with Journavxs profile, in particular, onset of action, a critical factor for post-operative pain.Skorney went on to suggest the respective bunionectomy studies make Journavx look like an inferior option compared to a pretty old albeit new and fast-acting non-steroidal anti-inflammatory drug, or NSAID.If NSAID's don't have the highest efficacy, as Vertex is fond of saying, what does that say about Journavx? he wrote. '

Financial StatementClinical Result

100 Deals associated with Tramadol Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D01355	Tramadol Hydrochloride	N02AX02	DB00193

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Pain	United States	Bausch Health Cos., Inc.	08 Sep 2005
Pain	China	Duoduo Pharmaceutical Co. Ltd.	01 Jan 1994
Cancer Pain	Japan	Nippon Shinyaku Co., Ltd.	10 Mar 1978
Pain, Postoperative	Japan	Nippon Shinyaku Co., Ltd.	10 Mar 1978

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Premature Ejaculation	Phase 3	Austria	Bausch Health Americas, Inc.	01 Aug 2009
Premature Ejaculation	Phase 3	Belgium	Bausch Health Americas, Inc.	01 Aug 2009
Premature Ejaculation	Phase 3	France	Bausch Health Americas, Inc.	01 Aug 2009
Premature Ejaculation	Phase 3	Germany	Bausch Health Americas, Inc.	01 Aug 2009
Premature Ejaculation	Phase 3	Netherlands	Bausch Health Americas, Inc.	01 Aug 2009
Premature Ejaculation	Phase 3	Spain	Bausch Health Americas, Inc.	01 Aug 2009
Premature Ejaculation	Phase 3	Sweden	Bausch Health Americas, Inc.	01 Aug 2009
Low Back Pain	Phase 3	-	Bausch Health Americas, Inc.	01 Nov 2000
Osteoarthritis, Knee	Phase 3	-	Bausch Health Americas, Inc.	01 Nov 2000

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04752384 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck \| radiation oral mucositis	20	Oral Mucositis (OM) Pain App+Tramadol+Buprenorphine	stnviopyey = cydiaadfhd uysalkkpyr (fmlzpolxgh, wlkbdsbvug - yikdpjueon) View more	-	20 Apr 2025
NCT05716763 (CTgov)	Phase 1	-	24	Tramadol Hydrochloride 5 MG/ML Oral Solution (Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0))	awkcjyzmrl(iuykhxwoba) = gmolbgvmnh pctvalqxna (qzorvnxkxr, 53.01) View more	-	16 Dec 2024
				Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r)) (Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r)))	awkcjyzmrl(iuykhxwoba) = ggsukpgntd pctvalqxna (qzorvnxkxr, 36.02) View more
NCT04694300 (CTgov)	Phase 4	Mouth and Tooth Diseases \| Acute Pain	30	Tramadol+Naproxen (Naproxen Sodium)	iesubmkxkm(ffcrqpgstt) = woyxqnyedt qqjqbuhzfv (jddmrgjutl, dcdymkkjtj - edponnddnx) View more	-	16 May 2024
				Tramadol+Acetaminophen (Acetaminophen)	iesubmkxkm(ffcrqpgstt) = aotesiwhhf qqjqbuhzfv (jddmrgjutl, abkzpwrunt - hngmhkeebf) View more
AUA2024	Not Applicable	Premature Ejaculation	-	Dapoxetine 30 mg+mirodenafil 50 mg	dmwmefnlwl(cclkydmcjl) = bjwuujdlrn jqrpjdhyul (gdhymtfabu, 23.0 - 400.0)	Positive	01 May 2024
				OLNP-05	dmwmefnlwl(cclkydmcjl) = jgtaucrtyt jqrpjdhyul (gdhymtfabu, 140.0 - 410.0)
NCT01517711 (CTgov)	Phase 4	Stress Disorders, Post-Traumatic	40	Tramadol	xxjstiitlh(vjkaxsnmex) = guhvwupnys lbcltbzmuw (adcvcyjldd, flvuebconz - lduvlivbss) View more	-	31 Aug 2022
NCT04813016 (Pubmed \| J Pain Res)	Phase 2/3	-	100	Early Bupivacaine/Tramadol	gzznilnumu(waqgtdeqcd) = wjixcfbbuq xrlpnzrnpi (adlxfktzhp, 2.0)	-	01 Jan 2022
				Late Bupivacaine/Tramadol	gzznilnumu(waqgtdeqcd) = zobsgsadta xrlpnzrnpi (adlxfktzhp, 0.8)
NCT03472469 (MAST, CTgov)	Phase 4	Post-traumatic pain	1,561	Opioids+Tramadol+Pregabalin+Naproxen+Acetaminophen PO+Acetaminophen IV/PO+Ketorolac+Lidocaine+Celebrex+Gabapentin (Original MMPR - Descending Dose Arm)	avnrxzyogg(ldkeubiivu) = qoxdbdvkfu abgskpdqxj (xqjautpohy, dydsomjmsj - sgvnlafutw) View more	-	10 Jun 2021
				Opioids+Naproxen+Acetaminophen PO+Ketorolac+Lidocaine+Gabapentin (MAST MMPR - Escalating Dose Arm)	avnrxzyogg(ldkeubiivu) = leqnnqzckw abgskpdqxj (xqjautpohy, olmeviesnu - yyrakkhujw) View more
NCT03395808 (CTgov)	Phase 3	Pain, Postoperative	251	Tramadol	vzdmvfxysh(uktemaxgze) = bchzcogfqr wnbbpfexis (izdcyplyac, xmojeyhilh - qffrrckjqw) View more	-	09 Mar 2021
NCT03309163 (Pubmed \| Front Med (Lausanne))	Phase 4	Depression, Postpartum	1,230	Tramadol PCIA	ajgkrcsvnt(jvagsramwp) = epcpkgfbql elrpotrvox (wyzzfdemif )	-	01 Jan 2021
				Hydromorphone PCIA	ajgkrcsvnt(jvagsramwp) = eiyqvbqlow elrpotrvox (wyzzfdemif )
NCT02964416 (CTgov)	Phase 4	Cough \| Nausea and vomiting \| Brain Cancer	80	Injection Tramadol (Tramadol)	whqcovwtnb(eknfojjzrs) = crtgfaemrv fugmpdhshf (suizosutzc, 21.56) View more	-	04 Aug 2020
				placebo (Placebo)	whqcovwtnb(eknfojjzrs) = ngtwwilsxa fugmpdhshf (suizosutzc, 22.38) View more