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Neumentum’s study confirms investigational non-opioid pain treatment performing as predicted

Neumentum said Monday that findings from its phase I study of NTM-001 (pre-mixed bag ketorolac for continuous infusion), confirmed 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.

Neumentum is looking forward to meet with the FDA on January 29 and is preparing to initiate its Phase III program after that.

Joseph Pergolizzi, MD, co-founder and executive chairman of Neumentum said that the study findings are very encouraging and that predicted pain relief is consistent across all subjects, with onset of effect as predicted and stable efficacy predicted for 24 hours.

 

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