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Elysium Therapeutics Advances Overdose Treatment with FDA

Elysium Therapeutics, a pioneering biopharmaceutical company, has reached a crucial milestone in its mission to combat the growing crisis of opioid overdoses, particularly those resulting from oral fentanyl consumption. The company successfully concluded a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA). This meeting centered on the clinical development of its innovative rescue therapy known as SOOPR™ (Synthetic Opioid Overdose Protection and Reversal).

In a statement following the meeting, CEO Greg Sturmer expressed optimism about the team's collaboration with the FDA. He stated, "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." The company is now focused on completing IND-enabling studies and plans to file an IND application within the next year.

SOOPR is designed to address the urgent need for effective rescue therapies that can swiftly counteract overdoses caused by synthetic opioids like fentanyl. Unlike conventional treatments, SOOPR employs a long-acting formulation of naloxone that offers a rapid onset of action, making it a promising option for those suffering from severe opioid overdoses. The drug aims to provide effective respiratory restoration for up to 24 hours, significantly reducing the risk of re-narcotization and the debilitating withdrawal symptoms that other agents often induce.

Research data from in vivo proof-of-concept studies indicate that SOOPR acts more quickly than naloxone, providing longer-lasting effects that are crucial in managing overdoses linked with prolonged fentanyl absorption. Current rescue methods, including Narcan®, are limited by their short duration and may lead to concerning re-narcotization events in overdose patients. Statistics highlight that 20% to 45% of victims initially rescued with naloxone may experience re-narcotization, potentially resulting in irreversible brain damage or even death.

Sturmer further highlighted the pressing need for improved rescue solutions, noting that approximately 40% of opioid overdose fatalities occur in individuals who have already been administered Narcan. This underscores the critical shortcomings of existing rescue agents that fail to align with the pharmacodynamics of long-acting synthetic opioid drugs.

Elysium Therapeutics aims not only to innovate in the realm of overdose reversal but also to establish higher safety standards within the opioid industry overall. Their promise of SMART™ (Safer Medicines Alleviate Risks and Trauma) products is reflective of their commitment to pioneering effective drugs that counteract the dangers associated with opioid usage and overdose scenarios.

With the rapid increase in deaths attributed to opioid use disorder, Elysium's developments represent a beacon of hope in the fight against this epidemic. Through their lead project, SOOPR, they aim to make a significant impact on the treatment landscape for opioid overdoses and restore lives affected by addiction.

For more information on Elysium Therapeutics and their work towards effective overdose treatments, visit their website at Elysium Therapeutics.