A possible new way to prevent fentanyl overdoses: monoclonal antibodies
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The Food and Drug Administration on Thursday gave a North Carolina biotech company the go-ahead to test if a monoclonal antibody can prevent people from overdosing on fentanyl.
Why it matters: The synthetic opiate is becoming a leading cause of death for people under 50. Naloxone is currently the most widely used drug to reverse an overdose, but researchers are looking at other treatments, including an experimental vaccine.
How it works: The genetically engineered antibody CSX-1004 from Cessation Therapeutics is designed to neutralize fentanyl molecules entering the bloodstream before they reach the brain, according to the company, which previously submitted a new drug application to the FDA.
- The antibody showed promise blocking fentanyl's potentially fatal effects on the respiratory systems of mice and non-human primates in trials funded in part by the National Institutes of Health.
- The company said the treatment doesn’t enter the brain, which limits addiction risk.
What they're saying: The clinical trial, which will start in August, could "introduce a potentially paradigm-shifting treatment to address the fentanyl epidemic in the U.S.," said Tracy Woody, CEO at Cessation Therapeutics.
Catch up fast: The public health response to the overdose crisis that's claimed more than 100,000 lives per year has largely centered on expanding access to addiction treatment, decriminalizing fentanyl test strips and targeting the trafficking of the synthetic opioid.
- But drugs for treating opioid use disorder aren’t guaranteed to reach the most high-risk patients, which can widen gaps in care.
- Antibody therapies have been used to boost people's immune systems to fight infections, including from COVID.
Go deeper: Fentanyl overdose death rate nearly quadrupled from 2016 to 2021
