Dr. Frank Vocci Receives U01 Subaward

Drs. Nikej Shah of Nirsum Labs and Frank Vocci of Friends Research Institute are Co-Principal Investigators of an NIH UG3/UH3 grant, “Development of a novel drug to treat opioid use disorder.” All IND-enabling studies have been completed and the Food and Drug Administration (FDA) granted an IND to Nirsum to proceed to Phase I trials. NRS-033, a pro-drug opioid antagonist, is currently completing Phase I human trials. Nirsum Labs has been awarded a second NIH U01 award, “Select Late-Stage CMC, Nonclinical Studies, and Quality Programs to Accelerate NRS-033 Towards Pivotal Studies and Registration in Opioid Use Disorder” in which Dr. Vocci will be a Co-investigator. The purpose of the newly funded cooperative agreement is to expedite NRS-033 into Phase 3 trials and FDA registration. Accordingly, late-stage chemistry and manufacturing controls data will be developed for the Active Pharmaceutical Ingredient (NRS-033) and the drug product (a room temperature stable ready-to-use prefilled syringe). Other registration enabling non-clinical studies will be performed and Nirsum Labs will engage with the FDA to discuss Phase 3 protocols and other requirements for New Drug Application registration.