Nuance Pharma announces the completion of dosing for all HNVs in the Phase I clinical study of its novel Ketorolac for IV infusion (NTM-001), a non-opioid analgesic drug co-developed with Neumentum. A total of 16 healthy normal volunteers (HNVs) were recruited for the Phase I clinical study. All subjects had completed sample collections up to 96 hours and passed a 15-day safety follow-up period. To date, there have been no serious adverse events or alarming safety concerns reported among any of the subjects. According to Nuance R&D head, sample data clean-up and statistical analysis are in progress. The Phase I clinical study is estimated to be completed later this year.

In late 2020, Nuance Pharma entered into an exclusive license agreement with Neumentum for the rights to develop and commercialize the novel intravenous infusion of ketorolac (NTM-001) in Greater China. The asset is currently in Phase III development in the U.S. for the short-term management of moderately severe pain.

"It gives me great pleasure to announce the smooth completion of Phase I dosing for NTM-001 in Hong Kong. This represents a crucial milestone for our collaboration with Neumentum and is indicative of a grand opening to the China clinical development program. NTM-001 provides injectable non-opioid analgesic to patients and will be a promising alternative candidate for the use of opioid drugs in analgesics," commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma. "We are looking forward to introducing this novel drug in Greater China to address unmet needs in the pain management market."

"We are very excited to have completed this important study for NTM-001, further demonstrating the safety of the compound," stated Joseph Pergolizzi MD, Executive Chairman of Neumentum. " We believe NTM-001 has the potential to significantly improve the standard of care for many patients experiencing moderately severe, acute pain requiring analgesia at the opioid level. We believe the results of this study further highlight the profile of NTM-001 as a potentially effective and safe short-term pain management solution and provide valuable information for the product's clinical program moving forward."