PALO ALTO, Calif., Sept. 6, 2018 /PRNewswire/ -- Neumentum, a pharmaceutical company dedicated to transforming the way pain is treated – without opioids – today announced it completed dosing the first cohort of patients in its phase I study of NTM-001 (pre-mixed bag ketorolac for continuous infusion).
NTM-001 is Neumentum's lead product candidate, a novel, alcohol-free formulation of the non-steroidal anti-inflammatory drug (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, potentially reducing the need for opioid pain relievers.
"Neumentum is developing new ways to manage pain without the risk of addiction, misuse or life-threatening side effects seen with opioids. We believe that people in pain deserve treatment options that are more effective and safer than those widely available today," said Scott Shively, co-founder and chief executive officer of Neumentum. "After surgery, patients requiring continuous pain relief have few non-opioid options. Most current alternative options are inadequate because they may require addition of opioids or necessitate multiple doses over the course of 24 hours, problems NTM-001 has been specifically designed to address."
The Phase I study of NTM-001 is designed to evaluate the pharmacokinetics of NTM-001 continuous infusion compared with ketorolac IV injection every 6 hours. The study will be comprised of 4 cohorts and will enroll 64 subjects at 2 sites.
Neumentum plans to initiate its pivotal Phase III study in early 2019, following successful completion of this Phase I study, and following an end-of-phase II meeting with the U.S. Food and Drug Administration (FDA). Neumentum successfully completed its investigational new drug (IND) process on August 1, 2018, dosing the first patient 12 days later.
"During our Type B meeting with FDA, we agreed to conduct our Phase I pharmacokinetic study and we look forward to seeking further guidance from the Division on the following pivotal Phase III program," said Joseph Pergolizzi, MD, co-founder and executive chairman of Neumentum. "Our experienced team has swiftly accomplished a series of major clinical development and regulatory milestones that reflect the urgency of the opioid crisis. We are on track to deliver a safe, effective, new option to healthcare providers and patients by mid-2021."
Neumentum was founded in March 2017, and since that time has successfully closed on multiple rounds of financing. The company has hired an outstanding team of experts with extensive drug development and commercial experience in the pain and neurology space.
Injectable ketorolac has been used for more than 30 years and is the most frequently administered non-opioid IV analgesic, with over 45 million doses given to patients each year. Neumentum plans to offer this proven treatment in a novel, stable formulation with a smooth PK profile over 24 hours, allowing for around-the-clock analgesia.
Limitations of opioids include their addictive potential, risk of life-threatening respiratory depression, frequent side effects such as nausea, vomiting and constipation that may increase health resource utilization, and the liability from their potential misuse, abuse and diversion.
Addressing a National Health Emergency
Neumentum's lead product candidate, NTM-001 may help address unmet needs for providers, 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.1 There were more than 17,000 deaths due to prescription opioid pain relievers in 2015, nearly three times the number of deaths in 1999.2
The FDA has announced new guidelines in developing non-opioid pain options in 2019.
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 about Neumentum, please visit www.neumentum.com.
1 Centers for Disease Control and Prevention, Prescription Opioid Overdose Data. https://www.cdc.gov/drugoverdose/data/overdose.html
2 National Institute on Drug Abuse, Overdose Death Rates. Supporting data. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates