Elysium Therapeutics Completes Pre-IND Meeting with FDA for First-Ever Technology Designed to Combat Oral Fentanyl Overdose

Reports alignment with FDA on next steps to progress clinical program for SOOPR™ as a potentially novel rescue therapy for oral fentanyl overdose

LYONS, Colo., Aug. 20, 2025 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to prevent and reverse overdoses caused by highly potent, synthetic opioids especially when ingested orally, today announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) focused on a planned first-in-human clinical trial investigating SOOPR™ (Synthetic Opioid Overdose Protection and Reversal) as a rescue treatment for overdoses brought on by synthetic opioids, including fentanyl.

"We are grateful for the productive conversation with the FDA and are confident that we have a clear path forward for our SOOPR clinical program," said Greg Sturmer, CEO of Elysium Therapeutics. "We look forward to receiving the formal minutes from our meeting, completing IND-enabling studies, and filing the IND application in the coming year."

SOOPR is a rapid-onset, long-acting rescue agent specifically designed to prevent and reverse overdoses from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan^® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 12 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization and severe withdrawal symptoms commonly associated with nalmefene and high-dose naloxone products. SOOPR is also designed to provide protection from same-day re-use of opioids.

Data from in vivo proof-of-concept studies of SOOPR demonstrated a more rapid onset of action versus naloxone and a significantly longer duration of action. This profile is especially useful in counteracting oral fentanyl overdoses associated with prolonged fentanyl absorption and exposure that often outlast the short-acting profile of Narcan.

Sturmer added: "Improved rescue therapies designed specifically to address fentanyl overdose are urgently needed as currently available short-acting opioid agonists, such as Narcan, do not align with the long-acting profile of synthetic opioid drugs and often induce severe withdrawal symptoms. As a result, 20 to 45% of fentanyl overdose victims initially rescued with naloxone experience a re-narcotization event, which can lead to brain damage and death, and approximately 40% of decedents from an opioid overdose have received Narcan."

About Elysium Therapeutics  
Elysium is an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral synthetic opioids, including fentanyl. Elysium is working to establish new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead technology, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), is a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. In addition, Elysium is developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain. For more information, please visit https://www.elysiumrx.com.

SOURCE Elysium Therapeutics