What's Happening?
Akyso Therapeutics has announced the successful completion of its Phase 1a trial for iSTEP-N, a naltrexone implant for opioid use disorder (OUD), and has received a $15 million grant from the National Institute on Drug Abuse (NIDA) to develop a buprenorphine implant. The iSTEP-N implant demonstrated sustained therapeutic plasma levels of naltrexone for three months, with potential for 12-month efficacy. The implant is designed to be bioabsorbable, eliminating the need for surgical removal. The new funding will support the development of iSTEP-B, a buprenorphine implant intended to provide extended-release treatment for OUD.
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Why It's Important?
The development of long-acting implants for OUD treatment represents a significant advancement in addressing the opioid crisis. Akyso's implants offer a discreet and long-term treatment option that could reduce relapse risk during recovery. The success of the iSTEP-N trial and the new funding for iSTEP-B highlight the potential for these implants to capture a substantial portion of the $3 billion OUD treatment market in the U.S. This development is crucial for public health and could lead to more effective management of opioid addiction.
What's Next?
Akyso plans to conduct a Phase 1b study for iSTEP-N in early 2026, comparing it to Vivitrol. The company will also advance the development of iSTEP-B, leveraging the NIDA grant to pursue clinical trials and regulatory approval. The progress of these implants will be closely monitored by healthcare professionals and policymakers as they seek innovative solutions to combat the opioid epidemic.
