“[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 1, 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. Since, in 2020 opioid deaths increased ~46%. OUD’s insidious impact is felt throughout American society, culture, politics, and the economy.
Nevertheless, today’s “standard of care” approved medications for OUD (MOUD) are essentially the same crude legacies as since the crisis mounted decades ago. Evidence shows when taken ideally, they clearly reduce relapse, but actual median retention is short ~30-45 days. Some MOUD have serious risks, restricting distribution. Underutilized, despite the limitations, <20% of patients get MOUD. Patients fully “detoxed” to abstinence in “rehab” usually go home un-initiated on MOUD, vulnerable to predictable relapse soon after, an omission tolerated by US practice guidelines, still evolving beyond ideological roots towards an evidence basis. Treated carelessly, sometimes predatorily, OUD is stigmatized as incurable, inevitably failing, and “difficult”.
The history of psychiatric disease and HIV resonates. Major depression was once regarded as “feebleness” and AIDS a “wrathful curse”. Treatments were crude, side-effect laden, or dosing regimens impossibly complex. Eventually, painstaking research yielded new medications, improving efficacy, tolerability, and retention. These successes proved clearly the biologic, not willful or moral, nature of those illnesses, displacing stigma and ideological practices with high rates of evidence-based care. Similarly, sparked by innovation, we believe the zeitgeist will shift for OUD.
Thankfully, awareness for OUD is already improving. The epidemic 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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