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NIH for testing experimental drugs to cure opioid needs

News Release

Thursday March 21, 2019

Early trial opens at the Clinical Center.

A clinical trial of an experimental drug to treat cravings associated with opioid use disorder (OUD) has begun in the National Institute of Health Clinical Center. The Phase I study in healthy adults will assess the safety of the test compound ANS-6637 and how it is treated in the body when given with another drug treated by the same liver enzyme pathway. The NIH National Institute for Allergy and Infectious Diseases (NIAID) helps to implement the trial, funded by NIH's Long Term (HEAL) Initiative, a comprehensive program to accelerate research efforts to stop the public health crisis of OUD.

"Opioid drugs play an important role in controlling pain, but have strong potential for abuse, as evidenced by the opioid epidemic that interferes with every region of the United States. Opioid abuse and abuse are associated with high-risk behaviors that can directly or indirectly cause infections with HIV or hepatitis C virus, other diseases and premature death, "says NIAID director Anthony S. Fauci, MD" Because substance use disorders and some infectious diseases are often intertwined, infectious medical doctors must understand and be prepared to address both issues in order to Opioid use causes an increase in the neurotransmitter dopamine in the brain and common use "rewires" brain reward system, possibly generating irresistible demands on both opioids and associated signals, such as injection equipment or drug addiction partners.

"At this time, there are few pharmacological interventions that specifically target cries that some patients experience have physical dependence or opioid use," noted Henry Masur, MD, head of the Clinical Center's Critical Care with the Icine Department, and a main researcher in the new trial. "This trial will lay the foundation for future studies; together, these can lead to effective treatments for the drug needs that hinder the pursuit of sobriety."

ANS-6637 is developed by Amygdala Neurosciences, Inc. Preclinical animal studies indicate that the compound inhibits it dopamine brake that accompanies opioid use in people with OUD, without affecting the degree of dopamine required for normal brain functions.

The trial records up to 50 healthy adults aged 1

8 to 65 years. Participants will stay in the Clinical Center in Bethesda, Maryland, for 10 days and return to a final outpatient visit after one week. On the first day, volunteers will receive a single dose of the licensed drug midazolam. Midazolam was chosen because its treatment of the body is well understood and serves as a template for liver metabolism. They will not receive any drug on day two. On study days three to seven, volunteers will receive 600 milligrams of ANS-6637 each day. On day eight, participants will receive midazolam and ANS-6637 together to see how the study agent affects midazolam levels. This, in turn, will help researchers understand how ANS-6637 is treated by the body, and set up the next phase of scientific investigation in patients with OUD.

"Opioid use disorder is a treatable disease that, like in the early days of HIV, has been held back from scientific advancement with stigma and misconception," said Sarah Kattakuzhy, MD, Associate Investigator and Assistant Professor at the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore. "With the support of the HEAL Initiative and NIAID, we can now assess a new potential therapeutic treatment in the treatment of OUD. If proven effective, ANS-6637 may be part of a comprehensive package of services, including damage, opioid agonist therapy and behavioral capabilities, so that we can offer our patients the highest level of evidence-based therapy. " Kattakuzhy and colleagues are planning further studies of ANS-6637 as treatment for OUD in clinical trials at the University of Maryland School of Medicine.

Further study data, Effects of ANS-6637 on midazolam pharmacokinetics in healthy volunteers, are available in clinical studies. Gov using the identifier NCT03831971.

NIAID conducts and supports research – at NIH, across the United States and worldwide – to study the causes of infectious and immuno-mediated diseases and to develop better ways to prevent, diagnose and treat these diseases. News releases, fact sheets and other NIAID related material can be found on NIAID's website.

About the National Institutes of Health (NIH):
NIH, the nation's medical research agency, comprises 27 institutes and centers and is part of U.S. Department of Health and Human Services. NIH is the primary federal agency that performs and supports basic, clinical and translational medical research and examines the causes, treatments and cures for both common and rare diseases. For more information on NIH and its programs, visit www.nih.gov.

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