PALO ALTO, Calif.--(BUSINESS WIRE)--Neumentum Inc., a pharmaceutical company dedicated to transforming the way pain is treated -- without opioids -- 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 as predicted by extensive pharmacokinetic and pharmacodynamic modeling that had been previously shared with the US Food and Drug Administration (FDA). Additionally, durable analgesic effect was predicted over 24 hours with a rapid onset anticipated, and NTM-001 was safe and well tolerated. This Phase I study is part of a program supporting what has the potential to be the first-ever NSAID approved for continuous infusion.
NTM-001 is Neumentum’s lead product candidate: a novel, alcohol-free formulation of the powerful NSAID ketorolac, in a pre-mixed bag designed for 24-hours of continuous infusion following surgery. It is being evaluated to manage moderately severe acute pain that requires analgesia at the opioid-level, usually in a postoperative setting.
The Phase I study of NTM-001 evaluated the pharmacokinetics of NTM-001 continuous infusion compared with ketorolac IV bolus injection every six hours. The overall study was comprised of four cohorts with a total of 67 treated subjects across two sites. The first study cohort evaluated 24 healthy adults ages 18 to 55 (12 male and 12 female), receiving the full dose of NTM-001 (96.5 mg of ketorolac consisting of a loading dose of 12.5 mg and 3.5 mg/hour continuous infusion over a 24-hour period). The remaining three cohorts evaluated older adults ages 65 or older without and with increasing levels of renal impairment. These three cohorts received a dosing regimen that was reduced by 50 percent.
“We are pleased with the overall results of this study,” said Joseph Pergolizzi, M.D., co-founder and executive chairman of Neumentum. “We were able to identify the optimal dosing in healthy adult, geriatric, and renally impaired populations that predict stable, safe analgesia for 24 hours post-surgery in all cohorts.”
“These findings confirm the previous modeling and ensure Neumentum keeps on track to potentially have the first continuously infused NSAID successfully developed for acute pain in the US,” said Scott Shively, co-founder and chief executive officer of Neumentum. “NTM-001 has the potential to reduce or replace opioid use in the post-surgical setting where there is clearly a need for non-opioid options. Neumentum is building a pipeline of products that if successfully developed, may reduce the need for opioids by providing viable safe alternatives.”
NTM-001 presentations at PAINWeek 2019 include:
- September 6, 2019 at 10:48 a.m. PDT: Abstract/poster #40 Oral presentation of Phase I Trial Results for NTM-001 (Novel Alcohol-free Formulation for Continuous 24h IV Infusion of Ketorolac from a Pre-Mixed Bag) Meets Target of Model-Informed Development. Preliminary Results for Healthy Young Volunteers of a Randomized, Controlled Pharmacokinetic Study of NTM-001 Compared with a Standard Bolus Regimen of IV Ketorolac
September 6, 2019: Abstract/poster #41
NTM-001: A Novel, Alcohol-free Formulation of Ketorolac Tromethamine in a Pre-Mixed Bag for Intravenous Continuous 24h Infusion; A Potential Alternative to Opioids to Treat Acute Moderately-Severe Post-Operative Pain
September 6, 2019: Abstract/poster #42
NTM-001: Evidence-Based and Modeling-Supported Development of a Novel Alternative to Opioids for Moderately Severe Acute Post-Operative Pain; A Literature Review Related to Safety and Efficacy Studies of Continuous IV Infusion of Ketorolac Tromethamine and the Proposed Dosing Regimen of NTM-001
September 6, 2019: Abstract/poster #39
Phase 1 Trial Results for NTM-001 (Novel Alcohol-free Formulation for Continuous 24h IV Infusion of Ketorolac from a Pre-Mixed Bag) Meet Targets of Model-Informed Development: Preliminary Results for Elderly Subjects with/without Renal Impairment of a Randomized, Controlled Pharmacokinetic Study of NTM-001 Compared with an IV Bolus Regimen of Ketorolac
Addressing a National Health Emergency
NTM-001 may help address unmet needs for providers, hospitals, payers and patients, offering effective pain treatment options without some of the potential disadvantages of opioids. America’s opioid crisis has been declared a national public health emergency.
Over 70 million surgical procedures are performed in the U.S. annually and postsurgical pain is routinely treated with opioid analgesics. Yet opioids are associated with side effects – some severe enough to be treatment limiting – and the potential for misuse and abuse. While diversion of opioids is well publicized in the retail setting, it is also a growing problem in the hospital setting, where theft and illegal transfer have become increasingly prevalent.
Every day more than 1,000 people are treated in emergency rooms for misusing prescription opioids. From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids. Overdose deaths involving prescription opioids were five times higher in 2017 than in 1999.
Neumentum is developing and plans to commercialize products that have the potential to effectively treat pain, without the risks of abuse, misuse and diversion seen with opioid analgesics. Neumentum’s lead product candidate, NTM-001 (novel, alcohol-free formulation of ketorolac in a pre-mixed bag for continuous IV infusion), has the potential to treat moderately severe acute pain that requires analgesia at the opioid level for up to 24 hours, usually in a postoperative setting, and to reduce the need for opioids. For more information, visit Neumentum.com.
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 Centers for Disease Control and Prevention, Prescription Opioid Overdose Data. https://www.cdc.gov/drugoverdose/data/overdose.html