China-based Nuance Pharma announced the initiation of subject enrollment and the first drug infusion in a Phase I clinical study for its ketorolac for IV infusion (NTM-001), a non-opioid analgesic co-developed with US-based Neumentum Inc.
Study Details
The Phase I study enrolled 16 healthy subjects, who have completed the 96-hour sample collection process and 15-day safety observation. No adverse events or health issues were reported. Data cleaning and statistical analysis are ongoing, with results expected by the end of 2022.
Product Profile
NTM-001 is a novel, alcohol-free formulation of ketorolac designed for continuous 24-hour IV infusion. Compared to opioids, it provides sustained pain relief without opioid-related side effects or the drawbacks of short-acting ketorolac boluses.
Partnership
Nuance Pharma entered into a USD 53 million licensing agreement with Neumentum in November 2020, securing exclusive development and commercialization rights to NTM-001. The drug is currently in a global pivotal Phase III study in Greater China for short-term postoperative moderate to severe pain.-Fineline Info & Tech
