Lifecore Biomedical Partners with Nirsum Labs to Advance Addiction Treatment

California-based, Lifecore Biomedical, has partnered with Nirsum Laboratories to provide CDMO services to support the clinical development of Nirsum's leading candidate for treating opioid use disorder (OUD) and alcohol use disorder (AUD), NRS-033. With the drug entering Phase 2 clinical trials, Lifecore will provide filled syringes for the studies.

Nirsum’s CEO, Dr. Nikej Shah, highlighted the urgent need for improved addiction treatments, noting that existing FDA-approved options are outdated and limited and expressing his optimism that NRS-033 could improve therapeutic retention and reduce relapse rates among patients seeking abstinence.

The following article originally appeared in Contract Pharma.

Lifecore Biomedical Inc., a fully integrated contract development and manufacturing organization (CDMO), has been selected by Nirsum Laboratories Inc. to provide CDMO services focused on supporting Nirsum’s clinical development of its lead development candidate, NRS-033.

Under the agreement, planned activities include assessing and transferring technology for the fill and finish process associated with NRS-033. Lifecore’s unique expertise in the fill and finish of sterile injectable pharmaceuticals will inform these assessments, enabling the development of a comprehensive commercialization strategy for NRS-033.

NRS-033 is an innovative treatment designed for opioid use disorder (OUD) and alcohol use disorder (AUD). Fully owned and developed by Nirsum, it is now moving into Phase 2 clinical trials. This newly established agreement will enable Lifecore to supply Nirsum with filled syringes for the clinical development of NRS-033.

“With growing concerns about opioid and alcohol addiction in the U.S. and beyond, we’re grateful for the opportunity to support Nirsum on this important and promising treatment. 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,” said Paul Josephs, CEO of Lifecore. “We are excited to add Nirsum to our growing list of customers and appreciative that their team has entrusted us to collaborate with them on these activities.”

“We believe that opioid and alcohol use disorders are enormous unmet needs, each with just a few decades-old, FDA-approved treatment options available. We believe NRS-033 will be a key innovation, solving the critical problem of short therapeutic retention of available therapies that results in high relapse rates for abstinence-seeking patients with OUD and AUD. By improving therapeutic retention with NRS-033, Nirsum aims to give hope to the millions of Americans with OUD and AUD,” said Nikej Shah, M.D., CEO of Nirsum Labs. “We are excited to begin our work with Lifecore to potentially help bring our important therapy through further clinical development and commercialization.”

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