Elysium Therapeutics announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for SOOPR™ (Synthetic Opioid Overdose Protection and Reversal), marking a significant milestone in developing the first technology specifically designed to combat oral fentanyl overdose. The Colorado-based biopharmaceutical company reported alignment with the FDA on next steps to progress the clinical program for this potentially novel rescue therapy.
"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."
Addressing Critical Limitations of Current Rescue Therapies
SOOPR represents a significant advancement over existing overdose reversal agents by utilizing a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The therapy 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.
The urgent need for improved rescue therapies is underscored by alarming statistics regarding current treatment failures. According to Sturmer, "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."
Superior Pharmacological Profile Demonstrated
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 pharmacological profile is especially critical in counteracting oral fentanyl overdoses, which are associated with prolonged fentanyl absorption and exposure that often outlast the short-acting profile of Narcan.
The technology is also designed to provide protection from same-day re-use of opioids, addressing a key vulnerability in current rescue protocols. Sturmer emphasized that "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."
Comprehensive Approach to Opioid Safety
Beyond SOOPR, Elysium Therapeutics is developing a broader portfolio of SMART™ (Safer Medicines Alleviate Risks and Trauma) products aimed at establishing new standards of safety in the opioid industry. The company is also advancing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain, representing a comprehensive approach to addressing opioid-related risks across the treatment spectrum.
The company's focus on oral synthetic opioid overdoses addresses a critical gap in current treatment paradigms, as tens of thousands of unnecessary overdose deaths each year exemplify the shortcomings of currently available rescue agents, including naloxone and nalmefene.
