A University of Maryland medical research institute has been tapped to test a promising opioid addiction treatment that aims to curb the cravings that are often responsible for relapses but not controlled well by other common therapies.
The Institute of Human Virology, a center in the school of medicine that normally focuses on infectious diseases, plans to announce today that it has won a $12 million federal grant to investigate the therapy over the next five or six years.
The institute will test the drug for Amygdala Neurosciences Inc., a California-based biopharmaceutical firm, along with the National Institutes of Health, which provided the funding. The effort is part of a NIH new program launched in April to speed scientific solutions for the national opioid addiction and overdose epidemic called the Helping to End Addiction Long-term, or HEAL, Initiative.
“There are other treatments, but no one has figured out cravings,” said Shyam Kottilil, professor of medicine and director of the institute’s division of clinical care and research. “Maybe we are able to find out where this field should go. It’s a much needed area of research.”
The chemical agent in the drug called ANS-6637 inhibits a surge of dopamine in the brain that provides the “high” and associated craving. It’s worked in animal models and the institute will test it in humans for safety and efficacy. The trials could include those the institute already treats as part of a local program to cure hepatitis C infections that are often spread by intravenous drug use along with other infectious diseases such as HIV.
The institute became interested in the opioid treatment research as a means of treating the whole patient, Kottilil said. It’s also a means of reducing harm from the drug epidemic. Those who relapse can contract, and spread, hepatitis again, he said.
Much of the testing will be done in Baltimore, which has been particularly hard hit by the opioid epidemic. There were 761 fatal overdoses last year in the city and 2,282 in the state, with most related to opioids including heroin or the more powerful fentanyl. Cocaine is also on the rise, and Kottilil said the therapy under investigation may be used for other types of cravings.
The therapy likely would be used together with other treatments, such as Suboxone, a form of buprenorphine that blocks the effects of opioids. Kottilil said Suboxone is effective, but the high relapse rates suggest that there is a need to continue looking for therapies.
Those who treat addiction say the institute’s researchers are rightfully focusing on a process in the brain to target the therapies.
“Finding effective medications in the treatment of addiction is crucial as it also adds to the needed view of addiction as a brain disorder with neurochemistry involved,” said Dr. Michael Fingerhood, an addiction specialist at Johns Hopkins Bayview Medical Center and associate professor of medicine and public health at Johns Hopkins University. “Medications that can impact brain processes that regulate craving would have a major impact.”
The NIH grant validates the potential of Amygdala Neurosciences’ therapy, said Peter M. Strumph, the company’s CEO.
“This is a great example of NIH and industry teaming up to accelerate development, in this case, for the benefit of people who suffer from opioid use disorder,” he said.
U.S. Rep. Elijah Cumming, a Maryland Democrat, and U.S. Sen. Elizabeth Warren, a Massachusetts Democrat, pushed for the increase in NIH funding to address addiction. The pair also worked on separate legislation winding through Congress for more funding for treatment and other means of addressing the opioid epidemic blamed for more than 49,000 deaths last year across the country, or more than two-third of all the overdose deaths.
“Baltimore City, one of the hardest hit communities in this national crisis, is a prime location for these clinical trials,” Cummings said. The institute “research that the NIH grant will support is exactly the kind of innovative work that the HEAL Initiative seeks to encourage to combat the opioid crisis that is devastating communities across the country.”