“[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, 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 disproportionately, in their prime, with fatalities averaging ~40 years of age. Even “pre-Covid”, while ascending globally, life expectancy in the US declined as last seen during World War I, driven by OUD. 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. By 2020 opioid deaths increased another ~46%. OUD’s insidious impact is felt throughout American society, its politics, culture, and economy.
Medications for OUD (MOUD) plus psychosocial counseling are the “gold standard” of care. Yet, today’s MOUD are essentially the same as decades ago, then and now, feeble barriers against the tide. In theory, MOUD should reduce relapse. But, some MOUD are themselves restricted opioids and/ or have short median treatment retention ~30 days. Thus, MOUD are under-utilized, taken by <20% of patients. Patients “detoxed” in “rehab” seeking abstinence usually go home un-initiated onto MOUD, contrary to clear evidence, predicting early relapse. Astonishingly, such therapeutic omissions are sanctioned by national treatment guidelines, still evolving from their ideological roots to an evidence basis. Resultant treatment “failures” trap patients between two opposing and equally stigmatizing narratives: relapse is their “fault” or lifetime opioid dependency is inescapable.
History is instructive. Depression was regarded an inherited “weakness”. HIV was deemed God’s “wrath”. Initial treatments were primitive, ineffective, or their dosing impossibly complex. Eventually, breakthrough medications dispelled doubts about the diseases’ biologic, not willful or spiritual, etiology, displacing sanctimonious conjuring with consistent evidence-based care. Similarly, sparked by innovation, the zeitgeist will shift for OUD.
Thankfully, 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 2nd generation HIV therapies drove AIDS mortality down >70% from US epidemic peaks, our mission is to 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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