FDS Insight Magazine Jun - Sep 2023

42 N EWS FROM O VERSEAS United States F ENTANYL CRISIS SPURS NEED FOR HELP WITH MULTIPLE - DRUG OVERDOSES he record number of Americans dying from a mix of drugs laced with fentanyl is driving research into medications that can eliminate multiple substances from the body. The National Institute on Drug Abuse is prioritizing research to counteract overdoses from more than one drug. One promising medication could start initial safety testing as soon as June or July. ‘Many people, if not most people, in some areas are dying with multiple substances in their body,’ said Sarah E. Wakeman, medical director for the Massachusetts General Hospital Substance Use Disorder Initiative. Fentanyl, a synthetic opioid that’s anywhere between 50 to 100 times stronger than morphine, is fuelling the latest wave of the opioid crisis, particularly when mixed with other drugs such as methamphetamine or cocaine. Those drug combinations make the drug overdose response ‘much harder and much more complex,’ NIDA Director Nora D. Volkow said. Expanded treatment options Volkow’s agency, which is part of the National Institutes of Health, has made expanding the range of treatment options for substance use disorders a key focus area. That work includes research into fentanyl vaccines and monoclonal antibodies that can can bind to methamphetamine and trap it before the drug enters the brain, heart tissue, and other organs. NIDA also is funding Clear Scientific’s pursuit of a treatment that can remove methamphetamine and fentanyl the same way existing products can remove toxins from the bloodstream. ‘It’s almost like Pac-Man,’ Clear Scientific CEO Shekar Shetty said. ‘Once it gets into your blood, it’s able to latch on to the target molecule, and it binds it and it removes it from the body to the urine.’ Clear Scientific is developing an intravenous version of its drug and also looking into an intramuscular version. Shetty said the Cambridge, Mass., biopharma company plans to submit its investigational new drug application to the Food and Drug Administration next month, with first-in-human safety studies potentially beginning this summer. More advanced clinical trials to determine dosing and to study how the drug interacts with the body could happen in the first quarter of next year. T