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Clinical Trials For New Drug To Be Arranged By NIH

The efficiency of a newly designed drug for treating cravings linked to opioid use disorder (OUD) is being examined by conducting a clinical trial at the National Institutes of Health Clinical Center. The Phase I safety trial of the experimental compound, ANS-6637 will be accessed on healthy adults, during which the side effects of the drug would be observed if it will be taken with some other drug targeting the same enzymatic pathway.

The several branches of the NIH are supporting and pushing the research efforts to prevent the public health crisis of OUD.

Anthony S. Fauci—director of NIH’s crucial branch, National Institute of Allergy and Infectious Diseases—stated that though opioid is an important medicinal compound that can help in controlling chronic pains, its addiction may even lead to dreadful consequences. Opioid addiction is associated with potential risks of illness by catching infections with HIV or hepatitis C virus, causing other health issues, and may even premature death.

Amygdala Neurosciences Inc. has developed ANS-6637 compound and the pre-clinical tests of this compound on model animals reveal that it restrains the flow of dopamine in the brain that occurs with opioid consumption in persons suffering from OUD, without influencing the actual levels of dopamine needed for normal functioning of the brain.

A clinical trial is to be conducted, in which 50 healthy adults will be enrolled having age between 18 and 65 Years. Participants will be provided accommodation for 10 Days in the Clinical Center in Bethesda, Maryland, and after one week, they will have to return for a final outpatient visit. During the 10-day trial, the dose of ANS-6637 will be given to the patients along with the licensed drug midazolam to check the impact of side effects or any cross-reaction in both the drug compounds.

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