“[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’s social mission is in developing new medications for opioid use disorder (OUD), the most significant, neglected public health crisis the US has faced in a generation. OUD kills more Americans yearly than traffic fatalities, HIV at its peak, breast cancer, or cumulative combat deaths in Vietnam. It afflicts young adults in their prime disproportionately, with fatalities averaging ~40 years of age. Even pre-Covid, life expectancy was increasing globally but declined in the US as last seen only during World War I, driven by OUD. And in 2020 opioid deaths increased another ~30% over 2019. The disease has flooded the foster care system with orphaned and near-orphaned children of afflicted parents. OUD cost the US >$1 trillion in 2017 alone. The disease has impacted every corner of American society, politics, culture, and economy.

Medications for OUD (MOUD) plus psychosocial counseling are the gold standard of care. Yet today’s few MOUDs are essentially the same ones from decades ago, then and now inadequate defenses against the tide of addiction. In theory, these MOUD should prevent relapse, but some options are themselves opioids or have short treatment retention. Given their shortcomings, these MOUD are under-prescribed, offered to <20% of patients. Patients seeking abstinence in detoxification programs, go home un-initiated onto MOUD in an estimated ~95% of cases, only to predictably relapse. The systematic lapse of MOUD initiation in such patients results from dissatisfaction with available options, as evidenced in national treatment guidelines. OUD patients are left stigmatized with the false narrative that durable opioid independence is unattainable.

History has shown that other false narratives about disease can change with the advent of new medicines. Depression was regarded an inherited “weakness;” HIV was deemed “God’s wrath”. Such beliefs were dispelled once breakthrough medications arose, demonstrating disease treatability and de-stigmatizing victims. Similarly, with innovation, the narrative will shift for OUD.

Awareness for OUD is already improving. It was declared a Public Health Emergency in 2017. Beating OUD is a bipartisan national imperative: the SUPPORT Act of 2019 passed 99 to 1 in the Senate. In cooperation with the National Institutes of Health (HEAL Initiative award UG3DA048234), Nirsum is all-in on the fight. Just as second-generation HIV therapies drove AIDS mortality down >70% from US epidemic peaks, our goal is to do the same 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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