ketorolac PMB (NTM-001) / Neumentum, Nuance Biotech - LARVOL DELTA

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=341 | Completed | Sponsor: NEMA Research, Inc. | Recruiting ➔ Completed

Trial completion • Pain

NTM-001 (Ketorolac Tromethamine 24 Hour Continuous Infusion): A 48-Hour Toxicity and Toxicokinetic Study in Minipigs, with a 14-Day Recovery Period (PAINWeek 2024) - "Due to technical issues, dosing was not continuous for nine minipigs, seven more received less than the intended dose, and two animals required extended infusion to achieve full dosing. All other animals received the full dosage with no interruptions. The mean administered NTM-001 doses were 0, 29.6, 140.9, and 279.1 mg/kg for Groups 1-4, respectively."

CNS Disorders • Pain

Characterization of Pain Management Regimens For Inpatients Receiving Bolus Ketorolac For Post-Surgical Pain Management – Results of a Retrospective Chart Audit of 597 Patient Records in 101 Hospitals Across the United States (PAINWeek 2024) - "A total of 597 patient charts were collected and analyzed from 101 hospitals with between 200 and 1536 beds (mean 532) across the US. Responses were provided by hospital pharmacists (38%), directors of pharmacies (31%), nurse practitioners (21%) and physician assistants (11%). The average age of patients included was 49 years, with 22% being elderly (≥65 years)."

Retrospective data • CNS Disorders • Pain

A Novel Formulation of Ketorolac Tromethamine (NTM-001) in Continuous Infusion in Adults with and without Renal Impairment: A Randomized Controlled Pharmacologic Study. (PubMed, Adv Ther) - "NTM-001 was considered safe and well tolerated in this population of participants ≥ 65 years, including in those with mild or moderate renal impairment. There were fewer adverse events in the continuous infusion group. The predictable pharmacologic properties and blood concentration levels suggest that continuous IV infusion of ketorolac can be used as an effective postoperative pain reliever in older subjects."

Journal • Pain • Renal Disease

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: NEMA Research, Inc. | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Pain

A Randomized Controlled Trial of a Novel Formulation of Ketorolac Tromethamine for Continuous Infusion (NTM-001) in Healthy Volunteers. (PubMed, Adv Ther) - "The PK parameters for NTM-001 and comparator bolus were similar to the modeling targets with no updating of the base model. There were no outliers and little intersubject variability. NTM-001 delivered as a bolus of 12.5 mg IV followed immediately by continuous infusion of 3.5 mg/h using a standard hospital infusion pump may offer an alternative to opioids for acute postoperative pain control."

Journal • Pain

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: NEMA Research, Inc. | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Pain

A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Nuance Pharma (shanghai) Co., Ltd | Recruiting ➔ Completed | Trial completion date: Nov 2022 ➔ Mar 2023

Trial completion • Trial completion date

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: NEMA Research, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2023 ➔ Sep 2023 | Trial primary completion date: Jan 2023 ➔ Jun 2023

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

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: NEMA Research, Inc. | Initiation date: Jul 2022 ➔ Nov 2022

Trial initiation date • Pain

A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Nuance Pharma (shanghai) Co., Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2022 ➔ Nov 2022

Enrollment open • Trial completion date

A Phase 1 Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Nuance Pharma (shanghai) Co., Ltd

New P1 trial

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: NEMA Research, Inc.

New P3 trial • Pain

[VIRTUAL] Current use patterns of ketorolac intravenous bolus for post-operative pain in inpatient settings. Results of a chart audit in 119 hospitals across the United States (ASHP 2020) - "NTM-001 (optimized formulation of ketorolac for continuous intravenous infusion over 24h) aims to mitigate those shortfalls... Intravenous ketorolac is widely used in US hospitals in major post-surgical settings for up to 24 hours. Dosing regimens in daily practice may be inconsistent with prescribing information, not following the appropriate dosing intervals, with the potential for increased side effects or insufficient analgesia. Elderly patients at risk may receive more than the appropriate, safe daily dose."

Clinical • Gastroenterology • Obstetrics • Oncology • Orthopedics • Pain • Pediatrics

[VIRTUAL] Final study results in elderly subjects with no, mild and moderate renal impairment meet targets of model-informed development for NTM-001 (ketorolac for continuous intravenous Infusion) (ASHP 2020) - "Final pharmacokinetic results for continuous intravenous infusion with NTM-001 in elderly volunteers with increasing levels of renal impairment show a high degree of similarity to the modeling targets and suggest in general an effective level of analgesia with a standard dose reduction by 50%. Administration with pre-programmed pumps contributed to high data quality. NTM-001 was well tolerated and safe without excessive exposure with increasing renal impairment and no signs of acute renal injury."

Clinical • Acute Kidney Injury • Pain • Renal Disease

[VIRTUAL] Final results of a randomized, controlled trial in healthy volunteers with NTM-001 (novel formulation of ketorolac for continuous intravenous Infusion) meet targets of model-informed development. (ASHP 2020) - "Final results of this first-in-man study in healthy volunteers confirm the concept and proposed dosing regimen (loading dose followed by continuous infusion) of NTM-001 supported by PK/PD modeling. A high degree of similarity to the established modeling targets was demonstrated with robust results requiring no update to the model. Prediction of stable analgesia over 24h was confirmed with a somewhat faster onset of effect for the loading dose."

Clinical • Pain • Renal Disease

Neumentum to Present New Data for Drug Candidate NTM-001 at the 2020 ASHP Midyear Clinical Meeting and Exhibition (GlobeNewswire) - "Neumentum Inc., a pharmaceutical company dedicated to transforming the way pain is treated – without opioids – will present three posters at the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition, being held virtually December 6-10, 2020; Results from evaluation of novel non-opioid analgesic NTM-001, under development for post-surgical pain, support pathway to potential Phase 3 pivotal trials in 2021."

Clinical data • New P3 trial • CNS Disorders • Pain

Neumentum and Nuance Biotech Enter into Licensing Agreement for NTM-001 (ketorolac for IV infusion) in China (GlobeNewswire) - "Neumentum Inc....today announced that the company has entered into a license agreement with Nuance Biotech Co. Ltd (Nuance)...providing Nuance with the exclusive rights to develop and commercialize Neumentum’s novel ketorolac for IV infusion (NTM-001) in China....'This collaboration with Nuance provides a path to develop NTM-001 in China, which has become a very large market for pain products, and validates the global need for non-opioid analgesics...'"

Licensing / partnership • CNS Disorders • Pain

Neumentum Provides Corporate Update on Company’s Pipeline of Non-opioid Analgesic Programs (GlobeNewswire) - "Neumentum Inc....today provided a corporate update on notable business accomplishments and priorities for...NTM-001....Based on the recent guidance letter received from the FDA, Neumentum has a clear understanding of the regulatory path forward for NTM-001, providing for rapid Phase 3 development. The company intends to initiate its Phase 3 pivotal, post-bunionectomy efficacy study following consummation of its next round of equity financing."

New P3 trial • CNS Disorders • Pain

Neumentum presents data on lead product candidate NTM-001 at PAINWeek 2019 (Businesswire) - "Neumentum Inc....announced new results from its Phase I study for NTM-001 at PAINWeek 2019. The Phase I results confirm that NTM-001 provides consistent, steady blood plasma levels of ketorolac over 24 hours...This Phase I study is part of a program supporting what has the potential to be the first-ever NSAID approved for continuous infusion."

P1 data