Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program

MATAWAN, N.J.--(BUSINESS WIRE)--Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) today welcomed the U.S. Food and Drug Administration’s (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting its potential to accelerate the company’s lead program, Apitox, for chronic osteoarthritis pain. The draft guidance, entitled “Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry”, can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain.

Erik Emerson, Chief Executive Officer of Apimeds, issued the following statement:

“The FDA’s draft guidance represents a landmark moment for companies like Apimeds that are committed to developing safe, non-opioid treatments for chronic pain. The agency’s call for flexibility in the number of required trials, openness to biomarkers, and willingness to accept strong scientific justification is more than regulatory encouragement; it’s an affirmation of the value of platforms like Apitox.

The guidance opens the door to more efficient development timelines, including the possibility of a single, well-controlled chronic pain trial supported by confirmatory evidence, along with potential fast track or breakthrough designations. For Apitox, this could translate into accelerating our path to regulatory submission, and ultimately, faster relief to patients suffering from osteoarthritis pain.

The FDA’s leadership in advancing non-opioid pain therapies is an important step toward reshaping how we approach one of the world’s most urgent healthcare challenges. For Apimeds, this guidance reinforces our belief that innovative biologic treatments like Apitox can redefine the standard of care in osteoarthritis and beyond. We are committed to working closely with regulators to bring safer, more effective solutions for pain management to patients as quickly as possible.”

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE American: APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company’s lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds’ website does not constitute a part of and is not incorporated by reference into this press release.

Forward-Looking Statements

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