Maxigesic (acetaminophen/ibuprofen) / AFT Pharma, Hyloris Pharma, BioSyent, Hikma - LARVOL DELTA

Drugs in Development to Manage Acute Pain. (PubMed, Drugs) - "These agents include VX-548 (Suzetrigine), Cebranopadol, AAT-076, Combogesic intravenous (IV), sublingual ketamine, XG004 (naproxen/pregabalin conjugate), and HTX-011 (Zynrelef). We analyze the pharmacodynamics, pharmacokinetics, development status, and clinical implications of these drugs, emphasizing the importance of finding an agent that provides both a strong safety profile and effective relief from acute pain. Our findings show promise but also highlight the need for further large-scale research to allow these drugs to be utilized in a clinical context for patients experiencing acute pain."

Journal • Review • Pain

A Pharmacokinetic study evaluating the pharmacokinetic parameters of different doses of Maxigesic® IV (intravenous paracetamol + intravenous ibuprofen) in healthy Japanese volunteers and Caucasian volunteers (ANZCTR) - P1 | N=24 | Completed | Sponsor: AFT Pharmaceuticals Ltd | Recruiting ➔ Completed

Trial completion

Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Seoul National University Hospital

New trial • Surgery • Breast Cancer • Oncology • Solid Tumor

Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section (clinicaltrials.gov) - P4 | N=84 | Not yet recruiting | Sponsor: Seoul National University Hospital

New P4 trial • Pain

A Pharmacokinetic study evaluating the pharmacokinetic parameters of different doses of Maxigesic® IV (intravenous paracetamol + intravenous ibuprofen) in healthy Japanese volunteers and Caucasian volunteers (ANZCTR) - P1 | N=24 | Recruiting | Sponsor: AFT Pharmaceuticals Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2024

Enrollment open • Trial initiation date

Intravenous acetaminophen/ibuprofen (Combogesic IV). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Pain

Hikma announces US launch of COMBOGESIC IV (PRNewswire) - "Hikma Pharmaceuticals PLC...announces the launch of COMBOGESIC IV (acetaminophen and ibuprofen) injection in the US."

Launch US • CNS Disorders • Pain

A Pharmacokinetic study evaluating the pharmacokinetic parameters of different doses of Maxigesic® IV (intravenous paracetamol + intravenous ibuprofen) in healthy Japanese volunteers and Caucasian volunteers (ANZCTR) - P1 | N=24 | Not yet recruiting | Sponsor: AFT Pharmaceuticals Ltd

New P1 trial

Analgesic Efficacy of Maxigesic in Breast Cancer Surgery (clinicaltrials.gov) - P=N/A | N=84 | Recruiting | Sponsor: Yonsei University

New trial • Surgery • Breast Cancer • Oncology • Pain • Solid Tumor

Maxigesic_Lung: Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption (clinicaltrials.gov) - P=N/A | N=96 | Completed | Sponsor: Seoul National University Hospital | Recruiting ➔ Completed

Trial completion • Pain

Hyloris announces U.S. FDA Approval of Maxigesic IV (GlobeNewswire) - "Hyloris Pharmaceuticals SA...announces Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary. The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program..."

sNDA • CNS Disorders • Pain

Hyloris Pharma wins US FDA approval for pain treatment (Yahoo Finance) - "The U.S. health regulator has approved Hyloris Pharmaceuticals' drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year. The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally. The U.S. Food and Drug Administration's decision was based on data from a late-stage study that showed the drug to be more effective in relieving pain than commonly-used intravenous paracetamol."

NDA • CNS Disorders • Pain

Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients (clinicaltrials.gov) - P4 | N=176 | Recruiting | Sponsor: Korea University Guro Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • CNS Disorders • Geriatric Disorders • Lung Cancer • Oncology • Solid Tumor

The Effect of Preoperative Maxigesic® on Intraoperative Remifentanil Requirement (clinicaltrials.gov) - P=N/A | N=96 | Not yet recruiting | Sponsor: Ajou University School of Medicine

New trial • Pain

Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy (clinicaltrials.gov) - P=N/A | N=154 | Recruiting | Sponsor: Seoul National University Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2023 ➔ Sep 2024 | Trial primary completion date: Sep 2023 ➔ Aug 2024

Enrollment open • Trial completion date • Trial primary completion date • Pain

Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption (clinicaltrials.gov) - P=N/A | N=96 | Recruiting | Sponsor: Seoul National University Hospital | Trial completion date: May 2024 ➔ Oct 2023

Surgery • Trial completion date • Pain

Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients (clinicaltrials.gov) - P4 | N=176 | Not yet recruiting | Sponsor: Korea University Guro Hospital

New P4 trial • Surgery • CNS Disorders • Geriatric Disorders • Lung Cancer • Oncology • Solid Tumor

Hyloris announces submission of Maxigesic IV packaging data requested by the US FDA (GlobeNewswire) - "Hyloris Pharmaceuticals SA...announces that its partner AFT Pharmaceuticals ('AFT') has submitted a response to the Food & Drug Administration (FDA). The US regulatory body had requested this additional data while considering market approval for Maxigesic® IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion....The formal response to the Complete Response Letter was filed with the FDA on 17 April 2023. Assuming a positive assessment by the FDA, this implies potential registration of Maxigesic® IV for the US market before year end."

FDA event • CNS Disorders • Pain

Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy (clinicaltrials.gov) - P=N/A | N=154 | Not yet recruiting | Sponsor: Seoul National University Hospital

New trial • Pain

Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption (clinicaltrials.gov) - P=N/A | N=96 | Recruiting | Sponsor: Seoul National University Hospital | Not yet recruiting ➔ Recruiting | Initiation date: May 2022 ➔ Oct 2022

Enrollment open • Trial initiation date • Video • Pain

"Hyloris Pharmaceuticals has received a complete response letter from the @US_FDA, seeking clarification on one topic related to its registration of Maxigesic IV. #HylorisPharma #FDA #BioSpace https://t.co/XJhU64eUyR" (@biospace)

Clinical • FDA event

Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption (clinicaltrials.gov) - P=N/A | N=96 | Not yet recruiting | Sponsor: Seoul National University Hospital

New trial • Video • Pain

"Pre-vaccination, @Drhaclarke recommends no OTC pain medications or antihistamines. Post-vaccination, acetaminophen, ibuprofen or #Combogesic may be taken if needed https://t.co/oJVZLZM4Ij via @InOttValley" (@DickieFox)

Pain

Hyloris Reports Full Year 2020 Financial Results (GlobeNewswire) - "Maxigesic IV is a novel combination of Paracetamol 1000mg + Ibuprofen 300mg solution for infusion for use post-operatively in hospitals for patients...successful completion of a second Phase 3 study in 232 subjects to support regulatory filing to the FDA. The submission of a scientific paper in a peer reviewed journal is currently being prepared....Maxigesic IV: submission of marketing application to the FDA by AFT Pharmaceuticals...With cash and cash equivalents of €64.40 million at year-end, the Company is well-capitalised to advance all current pipeline assets as planned and execute on its ambitious growth strategy with 14 commercial products expected by 2024."

Clinical • Commercial • Trial completion • CNS Disorders • Pain

Hyloris’ Partner AFT Pharmaceuticals Signs Licensing Agreement with Aguettant for Maxigesic IV in Eight European Markets (GlobeNewswire) - "Hyloris Pharmaceuticals...today announces that its partner AFT Pharmaceuticals ('AFT') has signed an exclusive licensing agreement with Aguettant for Maxigesic IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion...The agreement with Aguettant means that Maxigesic IV is now licensed in 20 out of the 27 EU member states (including the major pharma markets in the EU: Germany, France, Italy, and Spain) as well as the UK...AFT expects sales of Maxigesic IV in these territories to commence in early 2022...The market for post-operative pain is growing rapidly and is forecasted to reach $553 million in 2028 across the five major markets in Europe (up from $178 million in 2019)."

Licensing / partnership • Sales projection • CNS Disorders • Pain