PALO ALTO, Calif., Jan. 7, 2019 /PRNewswire/ -- Neumentum, a pharmaceutical company dedicated to transforming the way pain is treated – without opioids – today announced findings from its phase I study of NTM-001 (pre-mixed bag ketorolac for continuous infusion), confirming the investigational non-opioid pain treatment performs as it predicted in healthy adult volunteers.
NTM-001 is Neumentum's lead product candidate: a novel, alcohol-free formulation of the powerful 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.
The phase I study confirmed that NTM-001 provides consistent, steady blood plasma levels of ketorolac over 24 hours, as predicted by extensive pharmacokinetic and pharmacodynamic modelling Neumentum previously shared with the US Food and Drug Administration (FDA).
"The encouraging results keep Neumentum on track to potentially have the first continuously infused NSAID successfully developed for acute post-operative pain in the US, said Scott Shively, co-founder and chief executive officer of Neumentum. "The need for patients and providers to have effective non-opioid options is increasingly urgent."
Neumentum plans to meet with the FDA on January 29 and is preparing to initiate its Phase III program following this meeting.
"These study findings are very encouraging. Predicted pain relief is consistent across all subjects, with onset of effect as predicted and stable efficacy predicted for 24 hours," said Joseph Pergolizzi, MD, co-founder and executive chairman of Neumentum. "We are pleased to see that NTM-001 was well-tolerated, with no serious adverse events occurring in the study."
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 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 infused continuously 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.
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 in the US. 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. There were more than 17,000 deaths due to prescription opioid pain relievers in 2015, nearly three times the number of deaths in 1999.
The FDA has announced new guidelines in developing non-opioid pain options will be coming 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, visit Neumentum.com.
 Centers for Disease Control and Prevention, Prescription Opioid Overdose Data. https://www.cdc.gov/drugoverdose/data/overdose.html
 National Institute on Drug Abuse, Overdose Death Rates. Supporting data. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
 US Food and Drug Administration, Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency's ongoing work to forcefully address the opioid crisis. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618831.htm