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
MORRISTOWN, NJ, December 8, 2020 – 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.
The following poster presentations will be available on-demand at the ASHP Midyear Meeting and Exhibition website on Tuesday, December 8, 2020, 3:00 – 4:30 pm EST:
- Current Use Patterns for Ketorolac Intravenous Bolus for Post-Operative Pain in Inpatient Settings – Results of a Chart Audit in 119 Hospitals Across the United States
Presenter: Ilona Steigerwald, Chief Medical Officer, Neumentum, Inc.
Poster ID: 112 - 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
Presenter: Ilona Steigerwald, Chief Medical Officer, Neumentum, Inc.
Poster ID: 113 - 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)
Presenter: Ilona Steigerwald, Chief Medical Officer, Neumentum, Inc.
Poster ID: 114
The data to be presented include the final study results from four cohorts of a randomized, controlled clinical trial evaluating NTM-001, Neumentum’s novel, alcohol-free 24-hour continuous infusion formulation of the well-established potent NSAID analgesic ketorolac tromethamine. Neumentum is developing NTM-001 to potentially be a suitable alternative to opioids in the management of postoperative pain including in elderly and/or renally impaired patients.
“We are incredibly encouraged by the results from this first-in-man study evaluating NTM-001,” said Scott Shively, Chief Executive officer of Neumentum. “The data presented in these posters will spur us to conduct further research in the pursuit of safe and effective pain management without the risks for abuse and misuse that come with opioids.”
“This data underscore our commitment to validating NTM-001 with the very best science,” said Dr. Joseph Pergolizzi, Executive Chairman of Neumentum. “We look forward to the path ahead and to further validating these findings to address the global unmet needs of chronic and acute pain.”
Earlier this year, Neumentum shared a corporate update on the progression of its pipeline of non-opioid analgesic programs, which outlined the regulatory path forward for NTM-001, and the company’s intention to initiate a Phase 3 pivotal, post-bunionectomy efficacy study following the completion of its next round of equity financing.
About Neumentum: Addressing a National Health Emergency
Neumentum is dedicated to becoming a leading non-opioid analgesic and neurology specialty pharmaceutical company with product candidates that have the potential to provide the benefits of safe and effective pain management without the risks of abuse, misuse and diversion seen with opioids, or opioid-induced side effects including potentially life-threatening respiratory depression.
Opioid use is considered a critical public health concern in the US. In 2018, 9.9 million people over age of 12 reported misusing prescription opioid pain relievers1, and opioids were involved in 46,802 overdose deaths.2 Opioids also account for over 305,000 emergency department visits annually for non-fatal overdoses.3 Despite these staggering statistics, and the frequently reported opioid-induced side effects such as nausea, vomiting, constipation and somnolence, 168 million prescriptions – over 51 prescriptions per 100 Americans – were written for opioids in 2018.4
Neumentum has two lead product candidates being developed to directly help address the opioid crisis. NTM-006, a Phase 2 novel oral analgesic with a target indication for moderate to severe chronic pain, was licensed in late 2019 from Janssen Pharmaceuticals NV and McNeil Consumer Pharmaceuticals Co., both part of the Johnson & Johnson Family of Companies. NTM-001 is a Phase 3-ready IV formulation of Toradol (ketorolac), with recent Phase I results showing that it may provide consistent, steady blood plasma levels of ketorolac over 24 hours and durable analgesic effect. This Phase I study is part of a program supporting what has the potential to be the first-ever NSAID approved for continuous infusion.
Neumentum is led by a world-wide executive team of biotech and pharmaceutical industry leaders who have extensive experience in pain and neurology, from drug development through commercialization. For more information, visit www.Neumentum.com.
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INVESTOR CONTACT:
Scott Shively
CEO & Co-founder
scottshively@neumentum.com
(833) NEUPAIN
MEDIA CONTACT:
Megan Kernan
Westwicke, an ICR company
megan.kernan@westwicke.com
(952) 221-2096
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[1] SAMSHA, Key Substance Use and Mental Health Indicators in the US: Results from the 2018 National Survey on Drug Use and Health. P13, Fig 10. [2] Wilson N, Kariisa M, Seth P, Smith H IV, Davis NL. MMWR Morb Mortal Wkly Rep 2020; 69:290–297 [3] Vivolo-Kantor AM, Hoots BE, Scholl L, et al. MMWR Morb Mortal Wkly Rep 2020;69:371–376 [4] www.cdc.gov/drugoverdose/maps/rxrate-maps.html, accessed 16 Jul 2020