New Drugs on Horizon for Opioid Overdose, Withdrawal

Researchers are working on new medicines designed to prevent fentanyl overdose deaths and ease withdrawal symptoms that make it harder for people to stop misusing drugs.

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New drug options can help reduce opioid withdrawal symptoms like insomnia, to help in the recovery process.Getty Images

Drug overdose deaths have surged to record highs in recent years, accelerated by the increasing pervasiveness of fentanyl-laced street drugs and by limited access to care during the COVID-19 pandemic.

Overdose fatalities hit a grim milestone last year, surpassing 100,000 for the first time and shattering the record for annual fatalities set in 2020, according to the Centers for Disease Control and Prevention (CDC). Two-thirds of the overdose deaths in 2021 involved synthetic opioids like fentanyl.

“If you think about what has happened in the last two years since COVID began, it used to be that one person would die every 11 minutes of an overdose of opiates,” says Nancy Davis, cofounder and president of Cure Addiction Now (CAN), a nonprofit funding research to develop new treatments for substance use disorders. “Now it’s one person every 90 seconds.”

Davis, speaking at a forum highlighting CAN-funded research, stressed that many longstanding tools to prevent these deaths — like naloxone to reverse overdoses, buprenorphine to treat opioid use disorder, and test strips to detect fentanyl hidden in pills — simply aren’t helping enough people to halt the alarming spike in fatalities.

Part of the problem is that people can’t afford help or don’t know where to go for treatment, Davis says.

But two other challenges loom large in combating the current opioid epidemic: Existing treatments for opioid use disorder don’t do enough to ease patients’ cravings and withdrawal symptoms, and available medicines to reverse overdoses are no match for fentanyl.

A new nasal spray in development may help prevent more deaths from fentanyl, says Roger Crystal, MD, president and chief executive of Opiant Pharmaceuticals, and a guest speaker at the CAN forum. He’s the lead inventor of Narcan (naloxone), a nasal spray that can rapidly restore breathing that’s stopped because of an opioid overdose.

When people overdose from fentanyl-laced street drugs, their survival often depends on several doses of Narcan, Dr. Crystal says. The new, experimental nasal spray contains a different drug, nalmefene, that appears to have a faster onset and is longer lasting than Narcan in clinical trials.

“The strength of the breathing response was twice as fast as what we can achieve with Narcan,” Crystal says. His company plans to seek marketing approval from the U.S. Food and Drug Administration (FDA) for a nalmefene nasal spray in the first half of 2023 and start selling the drug by the end of next year.

Another treatment on the horizon aims to use Belsomra (suvorexant), a sleeping pill already approved by the FDA as a tool to help ease opioid withdrawal symptoms. Many other sleep aids are sedatives with the potential for addiction, and can’t be used to treat opioid use disorder. But Belsomra works differently by blocking signals to wake up, and it isn’t sedating or addictive, says Kelly Dunn, PhD, an opioid researcher at Johns Hopkins School of Medicine in Baltimore, who has received grant funding from CAN and presented her work at the forum.

When substance users stop opioids, withdrawal symptoms like cravings, anxiety, vomiting, diarrhea, shaking, and hot and cold flashes can all make it hard to sleep, Dr. Dunn says. And as people develop insomnia, it can make all of these withdrawal symptoms worse. “If a person wants to stop using opioids, we need to manage their withdrawal symptoms,” Dunn says.

In a small clinical trial of 38 people with opioid use disorder, patients taking the maximum 40-milligram FDA-approved dose of Belsomra slept 90 minutes more each night than patients on a placebo, or dummy pill. That far surpassed what scientists had hoped for — an extra 20 minutes of sleep, Dunn says. And, patients on the drug also experienced far fewer cravings and withdrawal symptoms.

Larger trials are still needed. But because the drug is already on the market, doctors are free to prescribe it for patients with opioid use disorder even though it isn’t yet FDA-approved for this use, says Kurt Rasmussen, PhD, chief scientific officer of Delix Therapeutics and a member of CAN’s scientific advisory board. “This is off-label, but very exciting,” says Dr. Rasmussen, who moderated the CAN forum.

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