Nirsum Labs selects Lifecore Biomedical for CDMO services for OUD, AUD candidate

Lifecore Biomedical announced that it has been selected by biotech company Nirsum Laboratories to provide CDMO services supporting Nirsum’s clinical development of its lead development candidate, NRS-033, a novel treatment for opioid use disorder and alcohol use disorder.

The work under the agreement will include the assessment and technology transfer of the fill and finish process for NRS-033. The assessment will leverage Lifecore’s expertise in the fill/finish of sterile injectable pharmaceutical products, with the potential for Lifecore to establish an overarching development and commercialization plan for the entire fill/finish process for the candidate.

Currently entering Phase 2 clinical development, the collaboration will position Lifecore to provide Nirsum with filled syringes for use in its clinical development.

“Our agreement will enable Lifecore to apply our experience with complex formulations to the assessment, enhancement and validation of the fill and finish process for NRS-033,” Lifecore CEO Paul Josephs said in a statement.

Lifecore is a fully integrated CDMO with expertise in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations.  

NRS-033’s development is funded in part through a cooperative agreement with the National Institutes of Health to develop a pharmacologic option superior to currently available therapies for opioid use disorder (OUD) and alcohol use disorder (AUD).

The U.S. prevalence of OUD and AUD is 9.4 million and 30 million people, respectively, representing a high unmet medical need with public health urgency.