SUMMIT, N.J., January 25, 2023 (Newswire.com) - Neumentum, a pharmaceutical company dedicated to transforming the way pain is treated - without opioids - today announced the initiation of its phase 3 study evaluating the efficacy and safety of its lead product candidate, NTM-001 (pre-mixed bag of ketorolac for continuous infusion), in patients with moderately-severe pain after bunionectomy surgery.
NTM-001 is a novel, alcohol-free formulation of the non-steroidal, anti-inflammatory drug (NSAID) ketorolac in a pre-mixed bag for continuous infusion over 24 hours. The phase 3 program is designed to achieve a broad indication for NTM-001 in the short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in the post-operative setting.
"We are excited to initiate this phase 3 program with this promising new drug candidate, NTM-001," said Dr. Ira Gottlieb, Principal Investigator for the study. "There is an urgent but unmet medical need for alternatives to opioids in the postoperative setting, and NTM-001 may be a solution to that problem."
J. Taggart McGurrin, CPA, MBA, JD, President and Chief Business Officer of Neumentum, added, "The potential benefit of NTM-001 is that it can deliver powerful pain relief for 24 hours that can reduce or even eliminate the need for any opioids for postoperative patients. Reducing the use of opioids is beneficial in many ways—it reduces the risk to patients, minimizes or eliminates distressing opioid-related side effects, and can reduce the length of hospital stays. It also lifts a lot of the burden of opioid stewardship from hospitals without compromising patient care." He went on to say, "We are pleased to partner once again with the esteemed NEMA Research team as the Contract Research Organization conducting this very important study."
This multicenter efficacy and safety study, NTM-001-CT-001, is a randomized, double-blind trial comparing NTM-001 intravenous (IV) infusion over 24 hours to placebo in patients with moderately severe postoperative pain after bunionectomy surgery. IV bolus morphine serves as an active comparator in the trial to determine assay sensitivity and support assessment of opioid-level analgesia. The primary endpoint of the study is the Summed Pain Intensity Difference over 24h (SPID24) from start to end of administration of treatment. Secondary endpoints related to analgesic effectiveness, quality of life, safety and tolerability, opioid consumption and pharmacokinetics will also be assessed. Topline results from the study are expected in second half 2023.
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 early- and late-stage 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 U.S. In 2020, 9.3 million people over age 12 reported misusing prescription opioid pain relievers1, and opioids were involved in 68,630 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, nearly 143 million prescriptions - over 43 prescriptions per 100 Americans - were written for opioids in 2020.4
Neumentum is led by an expert 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.
NTM-001 is a novel formulation of ketorolac, the most powerful NSAID, in a convenient-to-use pre-mixed bag for continuous infusion over 24 hours. It is in phase 3 development for the short-term management of moderately-severe acute pain that requires analgesia at the opioid level, usually in the postoperative setting. It is designed to deliver 24 hours of opioid-level analgesia, reduce the potential analgesic gaps associated with bolus ketorolac, reduce or eliminate the need for postoperative opioids, and shorten the length of hospital stay. If approved, NTM-001 will provide patients, professionals, and institutions with a powerful, injectable, non-opioid analgesic in a convenient ready-to-use pre-mixed bag, offering 24-hour analgesia without the side effects, risks, and liabilities of opioids or the disadvantages of short-acting injectable analgesics.
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.
Disclaimer: NTM-001 is an investigational new drug candidate and is not approved for any indication in any market.
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 SAMSHA, Key Substance Use and Mental Health Indicators in the US: Results from the 2020 National Survey on Drug Use and Health. P20, Fig 19.
 https://www.cdc.gov/drugoverdose/deaths/index.html, accessed 30 Sep 2022
 Vivolo-Kantor AM, Hoots BE, Scholl L, et al. MMWR Morb Mortal Wkly Rep 2020;69:371-376
 https://www.cdc.gov/drugoverdose/rxrate-maps/index.html, accessed 30 Sep 2022Contact Information:
President and Chief Business Officer
Original Source: Neumentum Announces Initiation of Phase 3 Program Evaluating Its Lead Product Candidate, NTM-001, for the Management of Moderately Severe Acute Pain