Elysium Therapeutics Unveils Promising Data on O2P™ Hydrocodone Prodrug for Acute Pain

Elysium Therapeutics has made significant strides in enhancing opioid safety through the successful Phase 1 clinical trial of its O2P™ hydrocodone prodrug. The study demonstrated that the prodrug is well-tolerated, provides effective pain relief for moderate-to-severe acute pain, and importantly, offers protection against overdose and abuse. This achievement marks a pivotal step towards redefining opioid safety standards within the pharmaceutical sector.

The O2P technology, central to Elysium's SMART™ (Safer Medicines Alleviate Risks and Trauma) opioids, is a bifunctional prodrug design that reduces the release of the opioid in cases where doses exceed the recommended limit. This innovation is applicable across various oral opioid agonists, potentially transforming the treatment of pain and addressing opioid use disorders.

Elysium's CEO, Greg Sturmer, highlighted the inadequacy of current non-opioid treatments and the risks associated with existing opioids, which contribute to poor pain management and increased healthcare costs in the U.S. The company's SMART opioids, spearheaded by O2P hydrocodone, are set to offer a superior analgesic option without the typical risks.

The Phase 1 trial, O2P-001, involved 93 subjects and assessed the safety, tolerability, and pharmacokinetics of O2P hydrocodone. The study's key outcomes showed that O2P hydrocodone had a good safety profile, even at higher doses, and its plasma concentration was effective for pain management with a longer duration of action. This suggests that patients could manage their pain with fewer doses, thereby reducing the risk of misuse and abuse.

Dr. Leela Vrishabhendra, the principal investigator of the study, and Tom Jenkins, Ph.D., Elysium's Chief Scientific Officer, both emphasized the potential of O2P technology to produce safer opioids that could mitigate the opioid crisis. The study's findings indicate that O2P hydrocodone significantly lowers the risk of oral overdose compared to traditional hydrocodone.

Elysium Therapeutics is poised to engage with the FDA to discuss the next steps for O2P hydrocodone, finalize clinical study protocols, and seek partnerships to bring safer opioid medications to market. The company's lead product, O2P hydrocodone, employs a unique trypsin-activated delivery system that releases hydrocodone in the small intestine and includes an inhibitor to control release at higher doses.

In addition to O2P hydrocodone, Elysium is developing SOOPR™, a long-acting opioid antagonist aimed at preventing and reversing synthetic opioid overdoses, such as those caused by fentanyl. This development addresses the shortcomings of current rescue agents like naloxone and nalmefene, which fail to prevent thousands of overdose deaths annually.

Elysium's commitment to innovation in the opioid industry is evident in their pursuit of safer and more effective treatments for acute pain, aiming to reduce the prevalence of opioid misuse and overdose while improving patient outcomes.

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