Naldebain (dinalbuphine) / Lumosa Therap - LARVOL DELTA

Evaluation of the analgesic efficacy of dinalbuphine sebacate in transoral robotic surgery for obstructive sleep apnea-hypopnea syndrome: a single-center retrospective cohort study. (PubMed, J Robot Surg) - "The DNS group exhibited a significantly lower percentage of opioid use during POD0-POD2 (30.21% vs. 54.76%, p < 0.001) and a reduced oral morphine equivalent dose (15.31 ± 36.68 mg vs. 56.79 ± 85.83 mg, p = 0.001). These findings support the integration of DNS into multimodal analgesia protocols for OSAHS surgery, substantially reduced inpatient and post-discharge opioid use (NNT ≈ 3-5) with small, likely non-clinically important differences in pain scores and no significant safety signal, supporting its clinical relevance in OSAHS surgical programs. Warranting further multicenter validation."

Journal • Retrospective data • Anesthesia • Obstructive Sleep Apnea • Pain • Respiratory Diseases • Sleep Disorder

Naldebain: Dinalbuphine Sebacate in Postoperative Pain Control After TKA (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Thammasat University

New P4 trial • Immunology • Orthopedics • Osteoarthritis • Pain • Rheumatology

Effect of Dinalbuphine sebacate on postoperative multimodal analgesic strategy in video-assisted thoracoscopic surgery: a double-blind randomized controlled trial. (PubMed, BMC Anesthesiol) - P4 | "By providing superior analgesia, reducing opioid requirements, improving functional recovery and its long-lasting effect after discharge, DS enhanced postoperative MMA for VATS."

Clinical • Journal • Video • Anesthesia • Pain

Postoperative Pain Management of Caesarean Section (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Mackay Memorial Hospital | N=150 ➔ 100 | Trial completion date: Jul 2024 ➔ Jul 2026 | Trial primary completion date: Apr 2024 ➔ Apr 2026

Enrollment change • Trial completion date • Trial primary completion date • Pain

Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section (clinicaltrials.gov) - P2/3 | N=120 | Recruiting | Sponsor: Dalin Tzu Chi General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Pain

PO Pain Management with Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery (clinicaltrials.gov) - P4 | N=76 | Completed | Sponsor: Tri-Service General Hospital | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2024

Surgery • Trial completion • Trial completion date • Anesthesia • Orthopedics • Pain

Amphiphilic NLC-Gel formulation loaded with Sebacoyl dinalbuphine ester and Nalbuphine for localized postoperative pain management. (PubMed, Int J Pharm) - "The inclusion of supplemental NA in the exterior gel (PA12-Gel + NA) provided rapid drug onset owing to swift NA dispersion, addressing acute pain within hours along with prolonged analgesic effects. Our findings suggest that this amphiphilic formulation significantly enhanced postoperative pain management in terms of safety and efficacy."

Journal • Hematological Disorders • Pain

Analgesic Effectiveness of Dinalbuphine Sebacate in Video-Assisted Thoracoscopic Wedge Resection and Its Effect on Reducing Postoperative Pulmonary Complications: A Retrospective Cohort Study. (PubMed, Asian J Anesthesiol) - "A single preoperative injection of DS reduced the frequency of salvage analgesic administration and total consumption of certain postoperative analgesics, suggesting the effective pain relief of DS, and it did not increase the incidence of PPCs. Additionally, it reduced the need for postoperative oxygen therapy, which may suggest a better prognosis and smoother postoperative pulmonary recovery for patients."

Journal • Retrospective data • Video • Pain

Postoperative Pain Management on Patients Undergoing Lung Tumor Resection (clinicaltrials.gov) - P=N/A | N=400 | Not yet recruiting | Sponsor: China Medical University Hospital

New trial • Lung Cancer • Oncology • Pain • Solid Tumor

Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section (clinicaltrials.gov) - P2/3 | N=120 | Not yet recruiting | Sponsor: Dalin Tzu Chi General Hospital

New P2/3 trial • Pain

Breast Milk Excretion of Dinalbuphine Sebacate Injection Administered After Cesarean Section. (PubMed, J Clin Pharmacol) - "Breast milk was collected throughout the 5-day posthospitalization interval from 20 mothers injected with one dose of extended-release dinalbuphine sebacate intramuscularly. The breast milk of women who receive one dose of dinalbuphine sebacate injection postpartum contains low nalbuphine concentration. In addition, dinalbuphine sebacate injection potentially reduces maternal pain intensity during the first postpartum week and offers low toxicity risk among breastfed infants."

Journal • Pain

Multimodal Analgesia With Extended-Release Dinalbuphine Sebacate for Perioperative Management: Expert Opinion and Consensus. (PubMed, Asian J Anesthesiol) - "Extended-release dinalbuphine sebacate combined with the MMA strategy can reduce the medical burden and improve the quality of recovery following surgery."

Journal • Anesthesia • Pain

Novel Opioids in the Setting of Acute Postoperative Pain: A Narrative Review. (PubMed, Pharmaceuticals (Basel)) - "Although traditional opioids such as morphine and oxycodone are commonly used in the management of acute postoperative pain, novel opioids may play a role as alternatives that provide potent pain relief while minimizing adverse effects...The more established include oliceridine (biased ligand activity to activate analgesia and downregulate opioid-related adverse events), tapentadol (mu-opioid agonist and norepinephrine reuptake inhibitor), and cebranopadol (mu-opioid agonist with nociceptin opioid peptide activity)-all of which have demonstrated success in the clinical setting when compared to traditional opioids. On the other hand, dinalbuphine sebacate (DNS; semi-synthetic mu partial antagonist and kappa agonist), dual enkephalinase inhibitors (STR-324, PL37, and PL265), and endomorphin-1 analog (CYT-1010) have shown good efficacy in preclinical studies with future plans for clinical trials. Rather than relying solely on mu-opioid receptor agonism to relieve pain and..."

Journal • Review • Anesthesia • CNS Disorders • Depression • Pain • Psychiatry • PENK

Combined Use of Naldebain® ER Injection and Precedex® After VATS (clinicaltrials.gov) - P4 | N=70 | Not yet recruiting | Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

New P4 trial • Surgery • Pain

PO Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery (clinicaltrials.gov) - P4 | N=76 | Recruiting | Sponsor: Tri-Service General Hospital | Trial completion date: Sep 2023 ➔ Oct 2024 | Trial primary completion date: Mar 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Anesthesia • Orthopedics • Pain

Postoperative Pain Management of Caesarean Section (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Mackay Memorial Hospital | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Pain

Efficacy and safety of an extended-release sebacoyl dinalbuphine ester for laparoscopic cholecystectomy: A randomized controlled trial. (PubMed, Medicine (Baltimore)) - "A single dose of extended-release analgesic SDE given intraoperatively did not provide sufficient add-on effect for acute and chronic pain management after laparoscopic cholecystectomies in patients who received standard postoperative MMA. Intramuscular injection of 150 mg SDE in patients with average body mass causes adverse events that could have been overlooked. More clinical studies are warranted to determine the target populations who may benefit from SDE injections for improvement of acute and chronic postsurgical pain management."

Journal • Anesthesia • Pain

Naldebain and Video-assisted Thoracoscopic Surgery (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: May 2023 ➔ May 2024

Surgery • Trial completion date • Trial primary completion date • Pruritus

Editorial: Case reports in neuropharmacology 2022. (PubMed, Front Pharmacol) - No abstract available

Journal

A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management (clinicaltrials.gov) - P2 | N=36 | Enrolling by invitation | Sponsor: Sinew Pharma Inc. | Recruiting ➔ Enrolling by invitation

Enrollment status • Musculoskeletal Diseases • Orthopedics • Pain

A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Sinew Pharma Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Diseases • Orthopedics • Pain

Injection Site Reactions Before and After Intramuscular Injection Technique Revision: A Postmarketing Analysis of NALDEBAIN® From 2017 to 2022. (PubMed, Asian J Anesthesiol) - "Injection site reactions were common after intramuscularly administered oil-based agents during the first year which is later markedly reduced by changing the length of the needle and injection education."

Journal • P4 data

A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Sinew Pharma Inc.

New P2 trial • Musculoskeletal Diseases • Orthopedics • Pain

Postoperative Pain Management on Uvulopalatopharyngoplasty Patients (clinicaltrials.gov) - P4 | N=78 | Not yet recruiting | Sponsor: Li-Jen Hsin

New P4 trial • Obstructive Sleep Apnea • Pain • Respiratory Diseases • Sleep Disorder

Naldebain for Pain Management After Knee Arthroplasty (clinicaltrials.gov) - P4 | N=80 | Completed | Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Nov 2022 | Trial primary completion date: Aug 2024 ➔ Nov 2022

Trial completion • Trial completion date • Trial primary completion date • Orthopedics • Pain • Rheumatology