APUS, Subsidiary of InskoBi, Expects to Benefit from New FDA Guidelines for Non-Opioid Pain Treatment Development

APUS (Apimeds US), the U.S. bio subsidiary of KOSPI-listed InskoBi, announced on September 17 that its therapeutic agent Apitox is expected to rapidly gain prominence as a beneficiary of the recently released U.S. Food and Drug Administration (FDA) guidelines for the development of non-opioid pain treatments.

According to InskoBi and APUS, the FDA recently issued guidelines for pain treatment development, which include granting expedited status to non-opioid alternative therapies. As a result, they anticipate that these guidelines will have a positive impact on the Phase 3 clinical trials of Apitox, a natural product that contains no opioid ingredients.

According to the U.S. Centers for Disease Control and Prevention (CDC), more than 108,000 people died from drug overdoses in the year ending April 2022. Notably, in 2020, 75% of drug overdose deaths were due to opioid pain medications.

With the FDA now granting expedited review status to potential opioid alternatives, interest in Apitoxin as a substitute therapy is increasing. Leveraging these new guidelines, APUS is accelerating the commercialization of Apitox and is actively considering expanding its pipeline by partnering with innovative non-opioid therapeutic companies in the United States.

In addition, APUS plans to begin Phase 3 clinical trials in January next year for patients with moderate knee osteoarthritis (OA), aiming to shorten the Biologics License Application (BLA) timeline. Apitox successfully completed Phase 3 clinical trials for general OA patients in 2019, securing a foundation for entry into the global market.

According to market research firm Grand View Research, the global non-opioid pain treatment market is projected to reach $45 billion in 2024, with an annual growth rate of 7-8%, expanding to $70 billion by 2030.

APUS has set early FDA approval and establishing a revenue base as its top priorities, and plans to expand indications to include autoimmune diseases such as multiple sclerosis (MS) in the future.

Erik Emerson, CEO of APUS, stated, "Non-opioid therapies are desperately needed alternatives for both patients and physicians. By rapidly completing Phase 3 trials for Apitox, we will establish an early revenue base and expand our pipeline in the United States, thereby demonstrating both global growth potential and social contribution."

This content was produced with the assistance of AI translation services.