Pharmather Holdings advances KETARx after FDA approval

Mr. Fabio Chianelli reports PHARMATHER ADVANCES KETAMINE PATCH AS NON-OPIOID PAIN RELIEF SOLUTION LEVERAGING FDA APPROVED IV KETAMINE (KETARX (TM)), ALIGNED WITH FDA'S CNPV NATIONAL PRIORITY INITIATIVE Pharmather Holdings Ltd. is advancing its ketamine transdermal patch as a next-generation, non-opioid pain-relief solution, building on the recent U.S. Food and Drug Administration approval of its IV ketamine product (KETARx). "With KETARx now FDA-approved, our next chapter is to expand ketamine's impact through an innovative transdermal patch that can redefine pain management," said Fabio Chianelli, founder and chief executive officer of Pharmather. "By addressing the unmet medical need for effective non-opioid pain relief, targeting a multibillion-dollar U.S. pain market and aligning with FDA's national priorities, we are positioned to accelerate development, achieve broad adoption and deliver long-term value for patients and shareholders." Unmet need for non-opioid pain relief The United States remains in the midst of a severe opioid epidemic, with more than 80,000 opioid overdose deaths in 2023, according to the CDC. Each year, over 50 million surgical and diagnostic procedures are performed in the U.S., and opioids remain the default for perioperative and chronic pain management. Despite their widespread use, opioids carry significant risks of dependence, misuse and overdose. The FDA and medical community have emphasized the urgent need for safe, effective and accessible non-opioid alternatives to reduce reliance on opioids for pain relief. Market opportunity The U.S. pain management market is valued at over $50-billion annually, with acute postoperative pain representing a $13-billion market opportunity and chronic pain conditions exceeding $30-billion annually. Given the scale of unmet need and the national urgency to reduce opioid dependence, Pharmather's ketamine patch has the potential to capture a significant share as a first-in-class non-opioid alternative. Ketamine patch: extending the value of KETARx The ketamine patch has been in development for several years and is designed to deliver controlled, sustained analgesia for both acute postoperative pain and chronic pain conditions, enabling adoption in hospital, outpatient and home-care settings. By leveraging the established safety profile, clinical experience and FDA approval of IV ketamine (KETARx), Pharmather aims to accelerate development of the patch as a scalable, patient-friendly, non-opioid solution that directly addresses this national public health crisis. Alignment with FDA priorities The FDA has identified non-opioid analgesics as a national priority and Pharmather intends to pursue the Commissioner's National Priority Voucher (CNPV) pilot program for the ketamine patch. This program offers the potential for ultra-accelerated NDA review timelines (as little as one to two months) for therapies that address national health crises such as the opioid epidemic. With IV ketamine already FDA-approved, Pharmather is uniquely positioned to leverage its regulatory, clinical and manufacturing expertise to advance the patch as a transformative pipeline asset. Strategic impact The combination of an approved IV ketamine platform (KETARx) and a novel transdermal delivery system creates a powerful dual strategy: IV ketamine: provides the proven clinical and regulatory foundation; Ketamine patch: expands ketamine's role into new care settings, offering a non-opioid alternative for millions of patients at risk of opioid exposure. Future opportunities In addition to its focus on pain management, Pharmather may also explore the potential of the ketamine patch for mental health conditions, such as treatment-resistant depression, suicidality and PTSD, where rapid and sustained delivery of ketamine could address urgent unmet needs in mental health care. About Pharmather Holdings Ltd. Pharmather Holdings is focused on unlocking the pharmaceutical potential of KETARx, an FDA-approved ketamine product for anesthesia and sedation in surgical and diagnostic procedures, while pursuing additional indications -- particularly rare disorders -- via the 505(b)(2) pathway and the development of a ketamine patch for pain and mental health conditions. We seek Safe Harbor.