Spark Biomedical, Inc. Granted $2.49M from the National Institutes of Health for a Clinical Trial Looking at Extended Use of Wearable Neurostimulation in Opioid Use Disorder Treatment

Spark Biomedical, Inc, the Hazelden Betty Ford Foundation, and Gaudenzia, Inc. Unite in Effort to Help Patients Reduce Relapse Risks and Sustain Recovery From Opioid Use Disorder

November 16, 2021, Dallas, TX — Spark Biomedical, Inc. has been helping patients overcome acute opioid withdrawal using its Sparrow Therapy System — Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief — since receiving FDA clearance in January 2021. However, acute withdrawal is only the first step in Opioid Use Disorder (OUD) treatment. Spark now has its eyes set on improving relapse prevention.

With the support of a $2.49M grant (1R44DA053876-01) from the National Institutes of Health HEAL Initiative, and in partnership with the Hazelden Betty Ford Foundation and Gaudenzia, Inc. — two of the nation's largest and most well-respected behavioral health care providers — Spark is set to launch a clinical trial to examine how tAN therapy, used over an extended period of time, can improve opioid addiction treatment retention by reducing post-acute opioid withdrawal symptoms as well as ongoing opioid cravings. Ultimately, this will help people stay engaged in their care, avoid returning to use, and sustain their recovery.

Clinical Trial Aims

The Sparrow Therapy System has already demonstrated that tAN therapy can successfully reduce acute opioid withdrawal symptoms within 60 minutes of treatment and maintain effectiveness throughout a five-day detox period. With this new NIH-funded, prospective, randomized, controlled, multi-center, two-phase clinical trial estimated to begin in January 2022, Spark Biomedical aims to further study:

• ‍The rate of treatment retention and withdrawal symptom reduction during acute detox — Using active and placebo tAN therapy in combination with active and placebo Lucemyra® (trial Phase I)
• The rate of relapse, reduction in opioid cravings, and post-acute withdrawal symptom reduction — Using tAN therapy with extended-release injectable naltrexone (Vivitrol®) compared to Vivitrol alone for three months (trial Phase II).
  

Principal Investigator and Spark’s Chief Science Officer, Dr. Navid Khodaparast, Ph.D., stated, "Opioid use disorder can be physically and psychologically taxing to the patient and their families. The Sparrow Therapy System is the only non-invasive, auricular neurostimulation therapy for mitigating opioid withdrawal symptoms, with no known side effects. In partnerships with Hazelden Betty Ford and Gaudenzia, we will collectively expand our understanding of how neurostimulation and pharmacologic treatments can improve addiction outcomes."

"As opioid use disorders continue to hurt families and claim more lives, there is an urgent need for diverse solutions that expand patient choices, meet individual needs and improve outcomes," said Alta DeRoo, MD, Chief Medical Officer of the Hazelden Betty Ford Foundation, the nation's largest nonprofit provider of addiction treatment, co-occurring mental health care, recovery resources, and related prevention and education services. "We'll be observing the effects of this wearable treatment on a spectrum of patients who initiate their care at our two largest residential treatment sites and are grateful to help advance the research on treatment options."

"We are very excited for this partnership and the potential for the Sparrow device to support those in recovery," said Quyen Ngo, Ph.D., LP, Executive Director of Hazelden Betty Ford's Butler Center for Research. "This device has the potential to increase individuals' abilities to fully engage in the recovery process by mitigating the physiological and biological factors that increase the risk of returning to use."

Dr. Dale Klatzker, Ph.D., CEO of Gaudenzia, Inc., stated, "Staying focused and engaged in long-term recovery is a challenging undertaking. The longer a person remains connected to some form of treatment, the better they will be at managing their recovery throughout their life. Participating in this trial for a non-invasive, non-opioid option that can reduce the desire to return to using opioids will help our clients build a stronger relationship to recovery."

Existing Medication-Assisted Treatment (MAT) Limitations

Opioid use in the U.S. has continued to rise since the 1990s, creating an opioid crisis that, according to the Centers for Disease Control, killed nearly 70,000 U.S. residents in 2020 alone1.

Currently, pharmacotherapy (MAT) options are the primary treatment for opioid withdrawal and effectively support many in their long-term recovery, including:

• ‍Full-agonist: Methadone
• ‍Partial-agonist: Buprenorphine
• ‍Full-antagonist: Naltrexone
• ‍Alpha(2)-agonist: Lofexidine

However, these options have limitations that Spark seeks to overcome.

Controlled Substance Limitations

Both methadone and buprenorphine are regulated by the Controlled Substances Act, meaning they can only be prescribed by licensed physicians designated to oversee opioid-based pharmacotherapies. Even with licensing, these physicians are limited to a specific number of patients per physician — up to 100 in year one and 275 in subsequent years. Unfortunately, there aren't enough licensed physicians with patient openings in the U.S. to cover the communities that need help the most. More to the point, fewer than 10% of primary care doctors can prescribe buprenorphine.2

Efficacy Limitations

Because they are non-opioid-based, Vivitrol and Lucemyra do not require specific licensing and are more easily prescribed, enabling these therapies to reach more patients. However, treatment efficacy and patient retention have been limited – meaning significantly fewer patients are using or seeking these non-opioid treatment options.

Through its upcoming clinical trial, Spark Biomedical ultimately seeks to broaden the footprint of readily available, effective treatment for acute withdrawal and long-term recovery support. Demonstrating the effectiveness of tAN therapy throughout the entire OUD treatment lifecycle could expand the indication of the Sparrow Therapy System and empower more patients to overcome opioid addiction.

Dr. Khodaparast further noted, “Expanding the bounds of Sparrow into the long-term addiction treatment setting could lead to a shift in clinical practice, lowering the rate of relapse, and most importantly overdose.”

About Spark Biomedical, Inc.

Spark Biomedical, Inc. is a U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the Company’s mission is to eliminate opioid addiction by working to address the full opioid addiction lifecycle, including:

• Withdrawal Management
• Relapse Prevention (Craving, Anxiety, Depression)

• Opioid Sparing
• PTSD/Trauma Abatement

Learn more at sparkbiomedical.com or on LinkedIn.

About Hazelden Betty Ford

The Hazelden Betty Ford Foundation is a force of healing and hope for individuals, families, and communities affected by addiction to alcohol and other drugs. As the nation’s leading nonprofit provider of comprehensive inpatient and outpatient addiction and mental health care for adults and youth, the Foundation has treatment centers and telehealth services nationwide as well as a network of collaborators throughout health care. With a legacy that began in 1949 and includes the 1982 founding of the Betty Ford Center, the Foundation today also encompasses a graduate school of addiction studies, a publishing division, an addiction research center, recovery advocacy and thought leadership, professional and medical education programs, school-based prevention resources and a specialized program for children who grow up in families with addiction. Learn more at HazeldenBettyFord.org and on Twitter.

About Gaudenzia, Inc.

Gaudenzia, Inc. is one of the largest nonprofit treatment and recovery centers focused on substance use disorders in the United States, with facilities operating in Pennsylvania, Maryland, Delaware, and Washington, D.C. The agency serves about 15,000 individuals annually and operates more than 100 programs for men and women with substance use and co-occurring disorders. Since 1968, Gaudenzia has provided specialized services and programs to users of all demographics, including pregnant and parenting mothers, adolescents, people with co-occurring mental illness and substance use disorders, and more. Those seeking help can call Gaudenzia’s 24/7 Treatment and Recovery Hotline at 833-976-HELP (4357). For more information, visit www.Gaudenzia.org.

About the NIH Grant

Research will be supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number 1R44DA053876-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

1 Data from CDC WONDER; 2020 — National Vital Statistics System, Provisional Drug Overdose Death Counts, Dec. 2020 predicted totals (not final data, subject to change).

2 Ryan McBain, Ph.D., M.P.H., policy researcher, RAND Corp., Boston; Lindsey Vuolo, J.D., M.P.H., director, health law and policy, Center on Addiction, New York City; Jan. 7, 2020, Annals of Internal Medicine