Last update 07 Dec 2024
Tramadol Hydrochloride
Last update 07 Dec 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Abidol, Tramadol, Tramadol hydrochloride (JP17/USP) + [63] |
Target |
Mechanism NET inhibitors(Norepinephrine transporter inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date JP (10 Mar 1978), |
RegulationOrphan Drug (US) |
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Structure
Molecular FormulaC16H26ClNO2 |
InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N |
CAS Registry36282-47-0 |
Related
478
Clinical Trials associated with Tramadol HydrochlorideEffectiveness of tramadol versus pentazocine in the control of labour pains among parturients at Enugu State University Teaching Hospital: a randomized controlled trial
Start Date02 Dec 2024 |
Sponsor / Collaborator- |
Comparison of preventive effect of tramadol and acetaminophen on control of postoperative pain after elective abdominal surgery under general anesthesia
Start Date05 Nov 2024 |
Sponsor / Collaborator- |
A comparative study of prophylactic Tramadol, Ketamine and Ondansetron in the prevention of intraoperative shivering in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. - NIL
Start Date03 Nov 2024 |
Sponsor / Collaborator- |
100 Clinical Results associated with Tramadol Hydrochloride
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100 Translational Medicine associated with Tramadol Hydrochloride
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100 Patents (Medical) associated with Tramadol Hydrochloride
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6,836
Literatures (Medical) associated with Tramadol Hydrochloride01 Jan 2025·JOURNAL OF CLINICAL ANESTHESIA
Comparative efficacy of intravenous treatments for perioperative shivering in patients undergoing caesarean delivery under neuraxial anaesthesia: A systematic review and Bayesian network meta-analysis of randomised-controlled trials
Review
Author: Blake, Lindsay ; Sultan, Pervez ; Ferrea, Guillermina ; Singh, Preet Mohinder ; Fedoruk, Kelly ; Carvalho, Brendan ; Singh, Narinder Pal ; Monks, David T
INTRODUCTION:
Shivering affects 52 % of patients undergoing caesarean delivery under neuraxial anaesthesia. Despite extensive research focused on its prevention, there is still no consensus regarding optimal pharmacological treatment. This systematic review and network meta-analysis aims to compare available intravenous treatments of perioperative shivering in patients undergoing caesarean delivery under neuraxial anaesthesia.
METHODS:
We searched seven databases (PubMed MEDLINE, Scopus, Web of Science, Embase, LILACS, Cochrane CRCT and clinicaltrials.gov) for randomised controlled trials comparing intravenous treatments of perioperative shivering during caesarean delivery and performed a Bayesian model network meta-analysis. We assessed study quality using the Cochrane risk of bias assessment tool. The primary outcome evaluated in this meta-analysis was shivering control (cessation or significant reduction in intensity), and secondary outcomes included time to shivering control, shivering recurrence, and incidence of maternal nausea.
RESULTS:
Twenty randomised controlled trials, with a total of 1983 patients, were included in this analysis. Network estimates of odds ratios (OR [95 % Credible Interval]) of effective treatment of shivering compared with saline were: dexmedetomidine (38.1 [14.2 to 111.5]), tramadol (33.6 [15.1 to 81.8]), nalbuphine (26.2 [10.8 to 80.2]), meperidine (20.9 [6.2 to 73.1]), ondansetron (6.6 [2.2 to 23.2]), and clonidine (3.2 [0.6 to 14.9]). The rank order of interventions by surface area under the cumulative ranking curve scores (in parenthesis) for shivering control was dexmedetomidine (0.87) > tramadol (0.85) > nalbuphine (0.74) > meperidine (0.66) > ondansetron (0.41) > clonidine (0.3) > amitriptyline (0.03). Dexmedetomidine was also the top-ranked intervention for time to shivering control, shivering recurrence and maternal nausea. We judged the certainty in the evidence to be moderate for dexmedetomidine and nalbuphine, and low for all other interventions.
CONCLUSION:
This network meta-analysis identified four effective intravenous treatments for shivering in patients undergoing caesarean delivery under neuraxial anaesthesia: dexmedetomidine, tramadol, nalbuphine and meperidine. Dexmedetomidine was the top-ranked intervention for all outcomes.
01 Jan 2025·Central nervous system agents in medicinal chemistry
A Review of the Association between Infections, Seizures, and Drugs
Article
Author: Tolou-Ghamari, Zahra
Background::
Seizures are a common presenting symptom of the central nervous system
(CNS) and could occur from infections (such as toxins) or drugs.
Objective::
The aim of this study was to present a systematic review of the association between infections,
seizures, and drugs.
Methods::
From their inception to 18 February 2024 relevant in-depth consequent guide approach
and the evidence-based choice were selected associated with a knowledgeable collection of current,
high-quality manuscripts.
Results::
Imbalance between inhibitory and excitatory neurotransmitters due to infections, drugs
such as ticarcillin, amoxicillin, oxacillin, penicillin G, ampicillin, tramadol, venlafaxine, cyclosporine,
tacrolimus, acyclovir, cellcept, the old generation of antiepileptic drugs, such as carbamazepine,
phenytoin, and many other drugs could cause different stages of CNS disturbances ranging
from seizure to encephalopathy. Infections could cause life-threatening status epilepticus by continuous
unremitting seizures lasting longer than 5 minutes or recurrent seizures. Meningitis, tuberculosis,
herpes simplex, cerebral toxoplasmosis, and many others could lead to status epilepticus.
In fact, confusion, encephalopathy, and myoclonus were reported with drugs, such as ticarcillin,
amoxicillin, oxacillin, penicillin G, ampicillin, and others. Penicillin G was reported as having the
greatest epileptogenic potential. A high dose, in addition to prolonged use of metronidazole, was
reported with seizure infection. Meropenem could decrease the concentration of valproic acid. Due
to the inhibition of cytochrome P450 3A4, the combination of clarithromycin and erythromycin
with carbamazepine needs vigilant monitoring.
Conclusion::
Due to changes in drug metabolism, co-administration of antiseizure drugs and antibiotics
may lead to an enhanced risk of seizures. In patients with neurocysticercosis, cerebral malaria,
viral encephalitis, bacterial meningitis, tuberculosis, and human immunodeficiency virus, the
evidence-based study recommended different mechanisms mediating epileptogenic properties of
toxins and drugs.
01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY
Bioactive phytocompounds profiling and the evaluation of analgesic, anti-inflammatory, and antihyperglycemic potential of Argyreia capitiformis (Poir.) Ooststr.: A combined n vitro, n vivo, and computational investigations
Article
Author: Hasan, Md. Nazmul ; Ahmed, Khondoker Shahin ; Devnath, Hiron Saraj ; Hossain, Arafat ; Oisay, Debasree Sen ; Biswas, Partha ; Medha, Maisha Maliha ; Hasan, Md Nazmul ; Sadhu, Samir Kumar ; Biswas, Biswajit ; Hossain, Hemayet ; Islam, Md. Naharul ; Islam, Md Naharul
ETHNOPHARMACOLOGICAL RELEVANCE:
Argyreia capitiformis (Poir.) Ooststr. (Convolvulaceae) is traditionally used by the Chakma community in the hilly region of Bangladesh to treat minor disorders such as pain.
AIM OF THE STUDY:
This study intended to determine the secondary metabolites to identify bioactive compounds and evaluate antioxidant potential, in vitro anti-inflammatory and in vivo analgesic, anti-inflammatory, and antihyperglycemic activities of A. capitiformis along with in silico investigations.
MATERIALS AND METHODS:
Chemical profiling was carried out using HPLC and GC-MS analysis. The analgesic effect was measured employing tail immersion and acetic acid-induced writhing methods. Following protein denaturation and formalin-induced paw edema, anti-inflammatory activity was studied. The antihyperglycemic potential was assessed using an oral glucose tolerance test (OGTT), while further mechanistic investigation was conducted using an alpha-glucosidase enzyme inhibitory assay. Simulations and molecular docking analyses were performed to ascertain the stability and binding affinities of the drug-protein complex.
RESULTS:
A. capitiformis ethanolic extract confirmed the presence of phenolics, alkaloids, flavonoids, terpenoids, tannins, gums, steroids, and reducing sugars. HPLC analysis revealed the presence of eight polyphenolic compounds, the most abundant of which was myricetin (64.10 ± 0.14 mg per 100 g dry extract). Moreover, the GC-MS analysis revealed twenty-four molecules, the most important of which was 2,4-bis (dimethylbenzyl)-6-t-butylphenol (9.19%). The concentrations of total flavonoids, total terpenoids, total phenolics, and total tannins were ascertained to be 142.48 mg QE/g, 173.1 mg UAE/g, 19.35 mg GAE/g, and 13.05 mg GAE/g, respectively. Furthermore, the plant extract had a total antioxidant capacity of 388 mg AAE/g. In the writhing assay, the plant extract suppressed writhing by 59.73% and 76.99% at the doses of 250 and 500 mg/kg, respectively, compared to the standard diclofenac Na 87.17%, and in the tail immersion assay, the plant extract displayed a maximum average reaction time of 1.94 and 2.40 s at the doses of 250 and 500 mg/kg, respectively as compared to the control tramadol 2.84 s at 60 min. In an in vitro anti-inflammatory assay, the plant extract possessed an IC50 of 95.51 μg/ml while diclofenac Na (standard drug) was found to be 69.50 μg/ml. Afterward, in vivo anti-inflammatory activity was observed in mice over a period, particularly after 3 h, the plant extract exerted maximum percent inflammation inhibitions of 36.36% and 45.45% at the doses of 250 and 500 mg/kg, respectively whereas ibuprofen the standard drug (100 mg/kg) exhibited 61.82%. The plant extract demonstrated antihyperglycemic activity, lowering blood sugar levels to 5.7 and 4.62 mM at doses of 250 and 500 mg/kg, respectively, as opposed to 8.58 mM in the control group. Meanwhile, the standard drug glibenclamide (5 mg/kg) dropped blood glucose levels to 2.38 mM in 60 min after glucose administration. Molecular docking (MD) and molecular dynamics simulation (MDS) studies support the stability of the protein complex responsible for exerting pharmacological activities.
CONCLUSION:
A. capitiformis extract exhibited strong medicinal values supporting its traditional uses.
56
News (Medical) associated with Tramadol Hydrochloride14 Nov 2024
- Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2024. “We have generated considerable momentum this past quarter in advancing our pipeline of innovative treatments for neurologic diseases,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “AJ201 is a potential best-in-class asset that would bring a disease-modifying therapeutic option to patients with significant unmet medical need in Kennedy’s Disease. Since dosing the last patient in the study in May, we continue to work diligently to move the study forward. We are looking forward to sharing topline clinical data in the coming months and building upon our progress of delivering impactful therapies to patients suffering from neurologic diseases.” Recent Corporate Highlights: AJ201 (Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for SBMA) In May 2024, Avenue announced the last patient visit was complete in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (SBMA), marking the final clinical milestone ahead of the anticipated topline data announcement around year-end 2024. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 enrolled 25 patients randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacokinetic and pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes from baseline in expression of Nrf2-activated genes in skeletal muscle. Exploratory objectives of the study include changes in the fat and muscle composition as seen on MRI scans. These endpoints are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). BAER-101 (GABAA α2/3 positive allosteric modulator) Subject to the receipt of additional financing, Avenue plans to initiate a Phase 2a clinical trial of BAER-101 in patients with focal epilepsy and other seizure disorders. Preclinical mouse models have demonstrated BAER-101 as a therapeutic option with the ability to fully suppress seizure activity, with the effect being fast in onset and stable throughout the duration of testing. IV Tramadol Avenue has reached final agreement with the U.S. Food and Drug Administration (“FDA”) on the safety study protocol and statistical analysis approach for the Phase 3 study of intravenous (“IV”) tramadol, which is being developed for the treatment of acute post-operative pain in a medically supervised setting. The proposed study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. Avenue aims to initiate the Phase 3 safety study pending additional financing or a partnership. The Company believes that the study can be completed and submitted to the FDA within 12 months of the study’s initiation. Financial Results: Cash Position: As of September 30, 2024, cash and cash equivalents totaled $2.6 million, compared to $4.9 million at June 30, 2024 and $1.8 million at December 31, 2023, a decrease of $2.3 million compared to the prior quarter and an increase of $0.8 million year-to-date.R&D Expenses: Research and development expenses for the third quarter of 2024 were $2.3 million, compared to $0.9 million for the third quarter of 2023.G&A Expenses: General and administrative expenses for the third quarter of 2024 were $0.8 million, compared to $1.2 million for the third quarter of 2023.Net Loss: Net loss attributable to common stockholders for the third quarter of 2024 was $(3.1) million, or $(1.92) per share, compared to net income of $0.5 million, or $4.86 per share, for the third quarter of 2023. About Avenue TherapeuticsAvenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com. Forward-Looking StatementsThis press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: the fact that we currently have no drug products for sale and that our success is dependent on our product candidates receiving regulatory approval and being successfully commercialized; the possibility that serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, such that we would need to abandon or limit development of some of our product candidates; our ability to successfully develop, partner, or commercialize any of our current or future product candidates including AJ201, IV tramadol, and BAER-101; the substantial doubt raised about our ability to continue as a going concern, which may hinder our ability to obtain future financing; the significant losses we have incurred since inception and our expectation that we will continue to incur losses for the foreseeable future; our need for substantial additional funding, which may not be available to us on acceptable terms, or at all, which unavailability could force us to delay, reduce or eliminate our product development programs or commercialization efforts; our reliance on third parties for several aspects of our operations; our reliance on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, unreliable, or unacceptable to regulatory authorities; the possibility that we may not receive regulatory approval for any or all of our product candidates, or that such approval may be significantly delayed due to scientific or regulatory reasons; the fact that even if one or more of our product candidates receives regulatory approval, they will remain subject to substantial regulatory scrutiny; the effects of current and future laws and regulations relating to fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations; the effects of competition for our product candidates and the potential for new products to emerge that provide different or better therapeutic alternatives for our targeted indications; the possibility that the government or third-party payors fail to provide adequate coverage and payment rates for our product candidates or any future products; our ability to establish sales and marketing capabilities or to enter into agreements with third parties to market and sell our product candidates; our exposure to potential product liability claims; related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our ability to maintain compliance with the obligations under our intellectual property licenses and funding arrangements with third parties, without which licenses and arrangements we could lose rights that are important to our business; the fact that Fortress Biotech, Inc. controls a majority of the voting power of our outstanding capital stock and has rights to receive significant share grants annually; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn JaffeAvenue Therapeutics, Inc. (781) 652-4500ir@avenuetx.com AVENUE THERAPEUTICS, INC.Unaudited Condensed Consolidated Balance Sheets($ in thousands, except for share and per share amounts)
September 30, December 31, 2024 2023
ASSETS
Current assets:
Cash and cash equivalents $2,597 $1,783 Prepaid expenses and other current assets 28 67 Total assets $2,625 $1,850
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses $427 $287 Accounts payable and accrued expenses - related party 517 323 Warrant liability 29 586 Total current liabilities 973 1,196
Total liabilities 973 1,196
Commitments and Contingencies
Stockholders’ equity
Preferred stock ($0.0001 par value), 2,000,000 shares authorized
Class A Preferred stock, 250,000 shares issued and outstanding as of September 30, 2024 and December 31, 2023 — — Common stock ($0.0001 par value) 200,000,000 and 75,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively
Common shares, 1,604,158 and 341,324 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively — 3 Additional paid-in capital 103,646 92,507 Accumulated deficit (101,036) (90,928)Total stockholders’ equity attributed to the Company 2,610 1,582
Non-controlling interests (958) (928)Total stockholders’ equity 1,652 654 Total liabilities and stockholders’ equity $2,625 $1,850 AVENUE THERAPEUTICS, INC.Unaudited Condensed Consolidated Statements of Operations($ in thousands, except for share and per share amounts) For the Three Months Ended September 30, For the Nine Months Ended September 30, 2024 2023 2024 2023 Operating expenses:
Research and development $2,327 $907 $6,080 $5,149 Research and development - licenses acquired — — — 4,230 General and administrative 829 1,161 3,607 3,042 Loss from operations (3,156) (2,068) (9,687) (12,421)
Other income (expense)
Interest income 51 9 152 104 Financing costs – warrant liabilities — — — (332)Loss on settlement of common stock warrant liabilities — — (759) — Change in fair value of warrant liabilities 18 2,572 157 (1,544)Total other income (expense) 69 2,581 (450) 1,316 Net (loss) income $(3,087) $513 $(10,137) $(11,105)
Net loss attributable to non-controlling interests (11) (13) (29) (88)Net (loss) income attributable to Avenue $(3,076) $526 $(10,108) $(11,017)
Net (loss) income attributable to common stockholders $(3,076) $526 $(18,918) $(11,017)
Net (loss) income per common share attributable to common stockholders, basic and diluted $(1.92) $4.86 $(17.27) $(115.55)
Weighted average number of common shares outstanding, basic and diluted 1,600,189 108,210 1,095,180 95,348
Financial StatementPhase 3Phase 2
30 Sep 2024
MONDAY, Sept. 30, 2024 -- In a clinical practice guideline issued by the American Academy of Pediatrics and published online Sept. 30 in
Pediatrics
, recommendations are presented for opioid prescribing for acute
pain
management in children and adolescents in outpatient settings.
Scott E. Hadland, M.D., M.P.H., from Harvard Medical School in Boston, and colleagues recommend that acute pain should be treated using a multimodal approach, including appropriate use of nonpharmacologic therapies, nonopioid medication, and opioid medication, when needed. For children and adolescents with acute pain, opioids should not be prescribed as monotherapy. Clinicians should prescribe immediate-release opioid formulations, start with the lowest age- and weight-appropriate doses, and provide an initial supply of five or fewer days when using opioids for acute pain management, unless the pain is related to trauma or surgery with an expected duration of more than five days. Codeine or tramadol should not be prescribed for children younger than 12 years; for adolescents age 12 to 18 years with obesity, obstructive sleep apnea, or severe lung disease; for treating postsurgical pain after tonsillectomy or adenoidectomy in patients younger than 18 years; or for any breastfeeding patient. Caution should be exercised when prescribing opioids for acute pain in children or adolescents who are taking sedating medications. Naloxone should be provided when opioids are prescribed, and patients and families should be counseled on the signs of opioid overdose and how to respond.
"For a patient with mild-to-moderate pain, doctors should always start nonopioid medications and treatment," coauthor Rita Agarwal, M.D., from the Stanford University School of Medicine in California, said in a statement.
Two authors disclosed ties to the pharmaceutical industry.
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19 Sep 2024
- Fourth-quarter revenue of $0.73 million, up 64% year-over-year – - Full-year revenue of $3.11 million, up 148% year-over-year – - As of June 30, 2024, the Company had $6.30 million in cash - NEW YORK, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, announced its financial results for the fiscal fourth quarter and full-year ended June 30, 2024, and provided a business update. Fiscal fourth quarter revenue totalled $0.73 million, an increase of 64% compared to the same period the prior year, and full-year revenue totalled $3.11 million, an increase of 148% compared to the prior fiscal year. As of June 30, 2024, the Company had $6.30 million in cash. “Our fiscal 2024 results reflect the dedication we have invested as a team to really drive the business forward,” said Harry Simeonidis, President and CEO at INBS. “Customer demand has remained strong, with orders increasing across the board as more businesses turn to our drug screening technology to safeguard their workforce and uphold their reputation for prioritizing safety. Our progress is promising, and we are continuously refining our strategy to ensure sustainable and profitable long-term growth. We remain on track for our planned FDA 510(k) submission in the fourth calendar quarter of this year and look forward to the opportunities this will unlock in 2025.” In addition, INBS reported a 20% increase in cartridge sales and a 26% increase in reader sales for the fiscal year ended June 30, 2024, compared to the prior fiscal year. With each reader needing a continuous supply of cartridges for testing, recurring revenue from cartridge sales has been a key driver in INBS’ continued growth across its active customer base of more than 400 businesses. Spiro Sakiris, CFO at INBS, commented, “We closed out fiscal 2024 with strong results. We have ensured revenue growth through concentrated expansion of our footprint, and with over 1,000 readers now installed, we are generating consistent and recurring revenue from cartridge sales. Awareness of our technology is growing, and we are seeing the results. Our next step is strategic geographical expansion, allowing us to enter new markets and further grow our customer network.” Operational Highlights for Fiscal 2024: On June 28, 2024, the Company announced the successful completion of the in-clinic portion of its Pharmacokinetic (PK) study, a core component of the Company’s clinical study plan for its 510(k) pathway for clearance by the United States Food and Drug Administration (FDA). The Company expects to complete the full PK study in the third calendar quarter of 2024.On April 11, 2024, the Company announced that its wholly owned subsidiary, Intelligent Fingerprinting Limited, had been granted a new European patent with unitary effect for its DSR-Plus Cartridge Reader, bringing the patent into effect in 17 European countries.On February 28, 2024, the Company announced its partnership with Cliantha Research to perform a pharmacokinetic (PK) study as part of its FDA 510(k) clinical study plan. Initiating the clinical studies plan represented a critical milestone for the Company.In December 2023, the National Association of Testing Authorities (NATA) accredited the Company’s laboratory partner, Racing Analytical Services Limited (RASL), to perform its fingerprint confirmatory drug testing procedure. This accreditation serves as an independent benchmark for technical validation, demonstrating the Company’s commitment to product quality, safety, and reliability for its customers.During the year, the Company announced new partnerships with Robinson Brothers, DGP Plc and James Jones & Sons, VKVP Haulage, State Road Constructions, Titan Cranes and Rigging Pty Ltd. and P&O Ferries. Additionally, the Company reported the successful completion of 25,000 Intelligent Fingerprinting tests by its existing customer, Auctus Management Group. Continued customer account growth demonstrates the strength of the Company’s proprietary fingerprint sweat-based technology in the market. The Company looks to continue this momentum and expand into new customer segments and geographical regions throughout the Asia-Pacific region (the “APAC Region”), Europe, South America and the United Arab Emirates.On October 24, 2023, the Company announced its expansion into the New Zealand market, expanding its global footprint and extending the reach of its drug screening product. Expansion into New Zealand demonstrates the Company’s ability to introduce its product in new markets. The Company aims to continue growth in new markets, offering an alternative and innovative solution that places a strong emphasis on operational efficiency, fitness for duty, employee privacy and dignity.On September 27, 2023, the Company announced that its Intelligent Fingerprinting Drug Screening business had obtained recertification for the latest ISO 13485: 2016 harmonized quality management system standard for the medical device industry. The recertification took effect on October 14, 2023, and is valid for three years. ISO 13485:2016 is the international standard for medical devices quality management system certification and is a requirement for medical device manufacturers operating across key regions, including the USA, Canada, Europe, Japan, Singapore, Malaysia and Saudi Arabia.On September 21, 2023, the Company announced the successful debut of its Intelligent Fingerprinting Drug Screening System at the 2023 Workplace Health & Safety Show in Sydney, Australia.On September 8, 2023, the Company announced the successful completion of a key development milestone in its plans to add ketamine and tramadol to its Intelligent Fingerprinting Drug Screening System. New assays for testing both drugs have passed the Company’s initial design phase and are ready for scale-up and transfer to manufacture in preparation for potential clinical trials. After completing these activities and successful clinical trials, the assays can be added to the panel of substances detected by the Company’s proprietary drug screening system.On August 1, 2023, the Company announced that it had secured 8 new customers across various locations throughout Australia, which collectively employ over 10,000 individuals, within just two months of launching its Intelligent Fingerprinting Drug Screening System in Australia.On July 6, 2023, the Company announced that it has signed a distribution agreement with Chile-based company TSCOM SPA for its Intelligent Fingerprinting Drug Screening System, increasing the product’s availability across South America. The Company further announced that it received its first order under this agreement, from a Chile-based electrical distribution company. Fourth Quarter and Full Year Ended June 30, 2024, Financial Results All amounts are expressed in U.S. dollars unless indicated otherwise. The Company’s revenue increased by 148% to $3.11 million for the fiscal year ended June 30, 2024, compared to $1.26 million for the fiscal year 2023. The increase in revenue is due to market demand, increasing brand and product awareness, and continued expansion of the Company’s customer base. Throughout fiscal year 2024, the Company launched its Intelligent Fingerprinting Drug Screening System in the APAC region through its subsidiary, Intelligent Bio Solutions (APAC) Pty Ltd, adding to its existing commercialization and marketing efforts in the United Kingdom and Europe. Loss from operations was $10.28 million for the 2024 fiscal year, compared to $12.59 million in the prior fiscal year. This improvement was primarily driven by an increase in revenue of $1.85 million and gross profit of $1.10 million, complemented by a reduction in total operating expenses of $1.53 million. The net loss attributable to INBS for fiscal year 2024 was $10.16 million, compared to $10.63 million in the prior fiscal year. This is mainly due to a fair value gain on the revaluation of financial instrument of $0.18 million in the fiscal year 2024 compared to $2.15 million in the prior fiscal year. As of June 30, 2024, the Company’s cash and cash equivalents totalled approximately $6.30 million. Financial Tables to Follow Intelligent Bio Solutions Inc.Consolidated Balance Sheets* As of June 30, As of June 30, 2024 2023 ASSETS
Current assets
Cash and cash equivalents $6,304,098 $1,537,244 Accounts receivable, net 429,704 293,861 Inventories, net 777,537 979,907 Research and development tax incentive receivable 525,332 498,758 Other current assets 497,572 552,791 Total current assets 8,534,243 3,862,561 Property and equipment, net 565,850 690,175 Operating lease right of use assets 306,744 546,475 Intangible assets, net 4,372,026 5,255,401 Total assets $13,778,863 $10,354,612
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses $1,704,568 $2,610,028 Current portion of operating lease liabilities 274,834 223,447 Current portion of deferred grant income 2,486,668 2,338,057 Current employee benefit liabilities 469,381 358,942 Current portion of notes payable 515,282 353,211 Total current liabilities 5,450,733 5,883,685 Employee benefit liabilities, less current portion 63,615 24,902 Operating lease liabilities, less current portion 81,324 356,165 Notes payable, less current portion - 402,862 Total liabilities 5,595,672 6,667,614 Commitments and contingencies
Shareholders’ equity
Common stock, $0.01 par value, 100,000,000 shares authorized, 3,456,000 and 194,200 shares issued and outstanding at June 30, 2024 and 2023, respectively* 34,557 1,942 Treasury stock, at cost, 116 shares as of June 30, 2024 and 2023, respectively* (1) (1)Additional paid-in capital 60,971,740 46,180,112 Accumulated deficit (51,964,332) (41,807,573)Accumulated other comprehensive loss (712,614) (575,496)Total consolidated Intelligent Bio Solutions Inc. equity 8,329,350 3,798,984 Non-controlling interest (146,159) (111,986)Total shareholders’ equity 8,183,191 3,686,998 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $13,778,863 $10,354,612 *Common Stock has been retroactively adjusted to reflect the decreased number of shares resulting from the 1-for-12 Reverse Stock Split on January 26, 2024, throughout the consolidated financial statements unless otherwise stated. The accompanying notes are an integral part of these consolidated financial statements. Intelligent Bio Solutions Inc.Consolidated Statements of Operations and Other Comprehensive Income (Loss)*
Year ended June 30, 2024 2023 Revenue $3,111,781 $1,256,872 Cost of revenue (exclusive of amortization shown separately below) (1,686,155) (930,204)Gross profit 1,425,626 326,668
Other income:
Government support income 424,776 737,628
Operating expenses:
Selling, general and administrative expenses (9,258,496) (8,026,703)Development and regulatory approval expenses (1,673,806) (507,424)Depreciation and amortization (1,201,274) (966,732)Goodwill impairment - (4,158,670)Total operating expenses (12,133,576) (13,659,529)Loss from operations (10,283,174) (12,595,233)
Other income (expense), net:
Interest expense (167,140) (223,534)Realized foreign exchange loss (1,178) (9,829)Fair value gain on revaluation of financial instrument 175,738 2,154,365 Interest income 84,822 9,676 Total other income, net 92,242 1,930,678 Net loss (10,190,932) (10,664,555)Net loss attributable to non-controlling interest (34,173) (32,835)Net loss attributable to Intelligent Bio Solutions Inc. $(10,156,759) $(10,631,720)
Other comprehensive income (loss), net of tax:
Foreign currency translation gain/ (loss) (137,118) 212,639 Total other comprehensive income (loss) (137,118) 212,639 Comprehensive loss (10,328,050) (10,451,916)Comprehensive loss attributable to non-controlling interest (34,173) (32,835)Comprehensive loss attributable to Intelligent Bio Solutions Inc. (10,293,877) (10,419,081)
Net loss per share, basic and diluted* $(6.38) $(127.00)Weighted average units outstanding, basic and diluted * 1,592,746 83,717 The accompanying notes are an integral part of these consolidated financial statements. *Common Stock and per share amounts have been retroactively adjusted to reflect the decreased number of shares resulting from the 1-for-12 Reverse Stock Split on January 26, 2024, throughout the consolidated financial statement unless otherwise stated. About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. Additionally, the Company’s biosensor platform has the potential to test for various indications, ranging from immunological conditions to communicable diseases. The Company’s current customer segments include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners. For more information, visit: http://www.ibs.inc/ Forward-Looking Statements: Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions’ public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Company Contact: Intelligent Bio Solutions Inc. info@ibs.inc Investor & Media Contact: Valter Pinto, Managing Director KCSA Strategic Communications PH: (212) 896-1254 INBS@kcsa.com
Financial Statement
100 Deals associated with Tramadol Hydrochloride
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D01355 | Tramadol Hydrochloride |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Chronic Pain | US | 08 Sep 2005 | |
| Pain | CN | 01 Jan 1994 | |
| Cancer Pain | JP | 10 Mar 1978 | |
| Pain, Postoperative | JP | 10 Mar 1978 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Premature Ejaculation | Phase 3 | AT | 01 Aug 2009 | |
| Premature Ejaculation | Phase 3 | BE | 01 Aug 2009 | |
| Premature Ejaculation | Phase 3 | FR | 01 Aug 2009 | |
| Premature Ejaculation | Phase 3 | DE | 01 Aug 2009 | |
| Premature Ejaculation | Phase 3 | NL | 01 Aug 2009 | |
| Premature Ejaculation | Phase 3 | ES | 01 Aug 2009 | |
| Premature Ejaculation | Phase 3 | SE | 01 Aug 2009 | |
| Low Back Pain | Phase 3 | - | 01 Nov 2000 | |
| Osteoarthritis, Knee | Phase 3 | - | 01 Nov 2000 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 4 | 30 | mtdwkqogoe(wjyjamvorr) = wgvawiekgw znezvgtcoh (wrhnmlxvod, mtyembmydf - snixszqypi) View more | - | 16 May 2024 | |||
(Acetaminophen) | mtdwkqogoe(wjyjamvorr) = wnnazprwxw znezvgtcoh (wrhnmlxvod, xpujabmpcy - kgzjisykwa) View more | ||||||
Not Applicable | - | tlcwwsxvxr(fovyhnnmqm) = hpitizxjqu vijpfhbeov (ohbitzvupc, 23.0 - 400.0) | Positive | 01 May 2024 | |||
OLNP-05 | tlcwwsxvxr(fovyhnnmqm) = umrzsuzfif vijpfhbeov (ohbitzvupc, 140.0 - 410.0) | ||||||
Phase 4 | 40 | bktplmpnef(qpvhhojyxx) = unqjzlbazw tjwmttjrpb (uucezefbho, gruwyheyla - tzimiwuiab) View more | - | 31 Aug 2022 | |||
Phase 2/3 | - | 100 | Early Bupivacaine/Tramadol | hidzqdmjqt(hziwgooxql) = gdcylubvaa mjzjwjuerf (bnvfqijkvz, 2.0) | - | 01 Jan 2022 | |
Late Bupivacaine/Tramadol | hidzqdmjqt(hziwgooxql) = ylrraakvlk mjzjwjuerf (bnvfqijkvz, 0.8) | ||||||
Phase 4 | 1,561 | (Original MMPR - Descending Dose Arm) | lswqluijfj(srihzueepi) = evgiwbjurt btgfhcmrfz (xydkfbgkvg, lbbnhjzqvv - mkhrkxfxcr) View more | - | 10 Jun 2021 | ||
(MAST MMPR - Escalating Dose Arm) | lswqluijfj(srihzueepi) = eiteynjgmk btgfhcmrfz (xydkfbgkvg, irphoibtly - pbshampghn) View more | ||||||
Phase 3 | 251 | qnmavsaosf(tziswjmwpg) = qcrkmfokxu mpvrsepthd (rfvjqaavan, bjmingdodx - pfptomjtam) View more | - | 09 Mar 2021 | |||
Phase 4 | 1,230 | Tramadol PCIA | zwgsvafswa(ymvreqevtk) = olxuvbhbja jlppvnfmjs (hkhwsvlnpm ) | - | 01 Jan 2021 | ||
Hydromorphone PCIA | zwgsvafswa(ymvreqevtk) = jwdygxkvhs jlppvnfmjs (hkhwsvlnpm ) | ||||||
Phase 4 | 63 | ixtwzllign(pzzaityysn) = bgbgbhejar kapilpipik (kypceyegrl ) | - | 04 Aug 2020 | |||
Paracetamol-diclofenac | ixtwzllign(pzzaityysn) = kdcvnwtmey kapilpipik (kypceyegrl ) | ||||||
Phase 4 | 80 | (Tramadol) | spcjwboown(zhtomhywsi) = kwmqrzutmd zrevwljhbj (sxxkbgstva, evuflsanvi - nxqgtfgqdj) View more | - | 04 Aug 2020 | ||
placebo (Placebo) | spcjwboown(zhtomhywsi) = fbivgkgksx zrevwljhbj (sxxkbgstva, pxmhllihnz - hgrurjmzmo) View more | ||||||
Not Applicable | - | woehsjjwnu(asbmpbvckk) = pdthbwezfs itqqmguycp (inevfucftb ) View more | - | 03 Jun 2020 | |||
woehsjjwnu(asbmpbvckk) = yrtzjdjsnp itqqmguycp (inevfucftb ) View more |
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