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NIH to test experimental drug to slow opioid needs



News release

Thursday, March 21, 2019

Early trial attempts at the Clinical Center.

A clinical study of an experimental drug designed to treat cravings associated with opioid use disorder (OUD) has begun in the National Institutes of Health Clinical Center. The Phase I trial 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 profile. NIH's National Institute of Allergy and Infectious Diseases (NIAID) helps carry out the study funded through 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 the fight against pain, but have strong potential for abuse, as evidenced by the opioid epidemic affecting all regions of the United States. Opioid abuse and addiction is associated with high-risk behavior directly or indirectly. indirectly can lead to infections with HIV or hepatitis C virus, other diseases and premature death, "says NIAID director Anthony S. Fauci, MD" Because drug disorder and some infectious diseases are often intertwined, infectious nurses must understand and be prepared for To treat both issues to provide optimal care for their patients. "Opioid use causes a wave of neurotransmitter dopamine in the brain and the usual use of" rewires "brain reward system, possibly creating irresistible demands on both opioids and associated signals, such as injection equipment or drug addiction partners.

"At this time, there are few pharmacological interventions specifically targeting the requirements some patients have physical dependency or opioid use disorder," noted Henry Masur, MD, Head of Clinical Center's Critical Care with the ICINE Department. , and a major researcher in the new trial. "This experiment will pave the way for future studies; together, these can lead to effective treatments for drug requirements that inhibit the exercise of graciousness."

ANS-6637 is developed by Amygdala Neurosciences, Inc. Animal preclinical studies suggest that the compound inhibits the dopamine flood that accompanies opioid use in people with OUD without affecting the background level of dopamine required for normal brain functions.

The sample records up to 50 healthy adults aged 1

8 to 65 years. Participants will stay at the Clinical Center in Bethesda, Maryland for 10 days and return to a final outpatient visit after one week. On the first day, volunteers receive a single dose of the licensed drug midazolam. Midazolam was chosen because its treatment of the body is well understood and acts as a template for liver metabolism. They receive no medication 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 create the next phase of scientific study in patients with OUD.

"Opioid use disorder is a treatment medical disorder that, like the early HIV HIV, has been withheld from scientific development by stigmatization and misunderstanding," 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 evaluate a novel potential therapeutic for OUD treatment. If it turns out to be effective, ANS-6637 can be part of a comprehensive package of services, including injury reduction, opioid agonist therapy and behavioral interventions, so we can offer our patients the highest level of evidence-based therapy. " Kattakuzhy and colleagues are planning further investigation of ANS-6637 as treatment for OUD in clinical trials at the University of Maryland School of Medicine.

Further information on the study, ANS-6637 influence on midazolam pharmacokinetics in healthy volunteers, is available in clinical trials. gov using the identifier NCT03831971.

NIAID carries out and supports research – at NIH across the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better means to prevent, diagnose and treat these diseases. Newsletters, fact sheets and other NIAID related materials are available on the NIAID website.

About the National Institutes of Health (NIH):
NIH, the nation's medical research agency, includes 27 institutes and centers and is a component of the US health and human ward. NIH is the primary federal agency that operates and supports basic, clinical and translational medical research, and examines causes, treatments and cures for both common and rare diseases. For more information on NIH and its programs, visit www.nih.gov.

NIH … Turning Discovery for Health ®

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