“[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

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 national economies is overwhelming. In 2018 alone, OUD cost the US $696 billion according to the Council of Economic Advisors.

Yet, today the disease has available only a few inadequately effective, poorly-accepted, and decades-old therapies. 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 for the condition. Similarly, psychiatric disease (e.g., major depression, bipolar) and HIV were once under-treated and dismissed as defects of “character” or “morals”, rather than of treatable biology. The advent of modern, effective therapies for those conditions heralded dramatic improvements in treatment rates and societal acceptance; the same will occur with OUD.

Already, the zeitgeist is shifting. Awareness, advocacy, and funding for OUD 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 and prevalent neuropsychiatric condition by the medical community, requiring new, effective treatments. In partnership with the National Institutes of Health  (HEAL Initiative award UG3DA048234), 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 adherence, 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.

Dan Deaver, PhD

Chief Scientific Officer

Dr. Deaver is Chief Scientific Officer of Nirsum, focussing on biology, toxicology, and ADME.

Mark Sorenson, PhD

Chief Development Officer

Dr Sorenson is Chief Development Officer of Nirsum, focussing on  Chemistry, Manufacturing, and Controls (CMC).

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


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