Neumentum and NEMA Research Inc. Named to Short-List of Citeline Awards for 2021

Nominated for Most Successful Early-Phase Research

MORRISTOWN, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- The Citeline Awards, sponsored by Informa Pharma Intelligence, today announced that Neumentum Inc. and NEMA Research, Inc., have been nominated and are in consideration for an award this year for Most Successful Early-Phase Research Company. Neumentum is pioneering the development of a powerful, effective nonopioid analgesic agent for use to control postoperative pain. This early-phase research study was designed to test the safety and toxicology of a 48-hour continuous infusion regimen of ketorolac tromethamine (NTM-001) which is intended to provide stable plasma levels of ketorolac rather than the peaks and troughs of bolus dosing. This 48-hour continuous infusion regimen is groundbreaking, and the study successfully demonstrated its safety and toxicology.

“Intravenous bolus dosing results in peaks in plasma levels immediately following the dose, and troughs in plasma levels at the end of the dosing period,” said Scott Shively, CEO of Neumentum. “When the drug in question is a pain reliever, the peaks can represent overexposure to the drug and potential side effects, and the troughs can result in analgesic gaps where pain is not well controlled. Neumentum is developing a novel continuous infusion of ketorolac tromethamine, NTM-001, to address these limitations associated with the bolus regimen.”

“Neumentum wanted to conduct a pre-clinical study with its novel formulation of ketorolac that required a continuous infusion over the course of 48 hours,” stated Robert Taylor, PhD, Executive Director of Operations for NEMA Research, Inc. “NEMA research collaborated with Neumentum to carefully design and conduct this challenging study and were pleased to demonstrate that ketorolac could be safely administered in this way.”

“We are very grateful to be considered for this prestigious award,” continued Mr. Shively, “and we are particularly grateful to be nominated together with NEMA Research, Inc., which was able to take our vision for this product and the regulatory necessity of conducting this difficult preclinical trial and produce such good results. We hope that our candidate drug will help to meet an urgent unmet medical need, and we found our colleagues at NEMA to be outstandingly responsive and personally invested in these same goals.”

Citeline Awards are given every year to honor large and small clinical research organizations for outstanding work. This year’s award ceremony will be held on October 14, 2021, in Boston, Massachusetts.

About Neumentum: Addressing a National Health Emergency

Neumentum, based in Summit NJ, 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 2 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.

About NEMA Research
NEMA Research is a clinical research organization headquartered in Naples, Florida. It works with global partners on a wide range of research projects.

NEUMENTUM INVESTOR CONTACT:
Scott Shively
CEO & Co-founder
[email protected]
(833) NEUPAIN

NEUMENTUM MEDIA CONTACT:
Megan Kernan
Westwicke, an ICR Company
[email protected]
(952) 221-2096

NEMA MEDIA CONTACT:
Jo Ann LeQuang
[email protected]
(979) 824-0251 

[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