Nirsum Labs was founded in response to the US epidemic of opioid use disorder (OUD).

Nirsum is developing new medications for opioid use disorder (OUD), the most significant and neglected public health crisis the US has faced in a generation. OUD kills more Americans yearly then traffic fatalities, HIV at its peak, breast cancer, or cumulative combat deaths in Vietnam. It afflicts young adults disproportionately, in their prime, with fatalities averaging ~40 years of age. OUD is responsible for the recent drop in US life expectancy, seen for the first time in decades. The disease has flooded the national foster care system with the orphaned and near-orphaned children of affected parents. The strain on local, state, and the national economies is overwhelming. In 2018 alone, OUD cost the US $696 billion according the Council of Economic Advisors.

Yet, today only a few poorly effective, problematic, older therapies are available for OUD,  considered by default the “gold standard” of care. As a result, OUD remains a refractory and relapsing condition, contributing to its stigmatization and under-treatment: only ~1 in 5 eligible patients receive any available medical therapy. As occurred historically with psychiatric disease (e.g., major depression, bipolar) and HIV, before the advent of their modern therapies, OUD has often been dismissed as a defect of “morals” or “character”, rather than of treatable biology.

The zeitgeist for OUD is now shifting. Awareness, advocacy, and funding are growing. The epidemic was declared a Public Health Emergency in 2017. Resource commitments to fighting the disease have bipartisan consensus: the SUPPORT Act of 2019 passed 99 to 1 in the Senate. OUD is now seen as a serious neuropsychiatric condition by the medical community, in dire need of more effective treatments. In partnership with the National Institutes of Health (NIH)/ National Institute On Drug Abuse (NIDA), Nirsum is aggressively working to fill the unmet need. Just as next generation HIV therapies drove AIDS mortality down >70% from US epidemic peaks, largely through improving therapeutic compliance and retention, Nirsum aims to help do as well for OUD.


Nikej Shah, MD

Chief Executive Officer

Dr. Shah is Founder, CEO, interim Chief Medical Officer and Co-Inventor of Nirsum’s foundational intellectual property.

“[The opioid crisis] is the most profound public health crisis facing the U.S. Food and Drug Administration and Americans… One of the critical ways the FDA can play a role is by encouraging more widespread innovation and development of medication for use in medication-assisted treatments (MAT)” – Former US FDA Commissioner Dr. Scott Gottlieb


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