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

Rhea-AI Summary

PharmaTher (OTCQB: PHRRF) is advancing its ketamine transdermal patch as a non-opioid pain relief solution, building on its recently FDA-approved IV ketamine product, KETARx™. The company is targeting the $50 billion U.S. pain management market, including $13 billion in acute postoperative pain and $30 billion in chronic pain conditions.

The ketamine patch aims to provide controlled, sustained analgesia for both acute and chronic pain, suitable for hospital, outpatient, and home-care settings. PharmaTher plans to pursue the FDA's Commissioner's National Priority Voucher (CNPV) Pilot Program, potentially enabling an accelerated NDA review of just 1-2 months. The development aligns with FDA's priority to address the opioid epidemic, which caused over 80,000 deaths in 2023.

Positive

• Recently received FDA approval for IV ketamine product KETARx™
• Targeting massive $50 billion U.S. pain management market opportunity
• Potential ultra-accelerated FDA review through CNPV Pilot Program (1-2 months)
• Dual strategy combining approved IV ketamine with novel transdermal delivery system
• Additional potential applications in mental health conditions

Negative

• Ketamine patch still in development phase
• Will face competition in crowded pain management market
• Success dependent on FDA approval and market adoption

Toronto, Ontario--(Newsfile Corp. - August 27, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, today announced the advancement of its ketamine transdermal patch as a next-generation, non-opioid pain relief solution, building on the recent FDA 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 CEO of PharmaTher. "By addressing the unmet medical need for effective non-opioid pain relief, targeting a multi-billion-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 CDC¹. Each year, over 50 million surgical and diagnostic procedures are performed in the U.S.², 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^3-6. 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 1-2 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

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) 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. For more information, visit PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "closer", "could", "confident", "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "promise", "strong", "aim", "may", "plan", "proposed", "lead", "toward", "anticipate", "provide", "position", "leverage", "mitigate", "before", "prior", and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and nine months ended February 28, 2025 dated April 24, 2025, which is available on the Company's profile at www.sedarplus.ca.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

References:

1. https://www.cdc.gov/overdose-prevention/about/index.html
2. https://www.cdc.gov/nchs/fastats/inpatient-surgery.htm
3. https://www.mordorintelligence.com/industry-reports/post-operative-pain-management-market
4. https://www.futuremarketinsights.com/reports/postoperative-pain-market
5. https://www.futuremarketinsights.com/reports/chronic-pain-market
6. https://www.imarcgroup.com/chronic-pain-market

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/264087

FAQ

What is PharmaTher's (PHRRF) new ketamine patch development about?

PharmaTher is developing a ketamine transdermal patch as a non-opioid pain relief solution for both acute postoperative and chronic pain, building on their FDA-approved IV ketamine product KETARx™.

How big is the market opportunity for PharmaTher's (PHRRF) ketamine patch?

The company is targeting a $50 billion U.S. pain management market, with $13 billion in acute postoperative pain and $30 billion in chronic pain conditions.

What advantages does PharmaTher's (PHRRF) ketamine patch offer?

The patch offers controlled, sustained pain relief without opioids, can be used in multiple settings (hospital, outpatient, home-care), and leverages the established safety profile of FDA-approved IV ketamine.

How does PharmaTher's ketamine patch align with FDA priorities?

The patch aligns with FDA's national priority to develop non-opioid analgesics, making it eligible for the CNPV Pilot Program that could enable ultra-accelerated review (1-2 months).

What additional applications is PharmaTher exploring for its ketamine patch?

Beyond pain management, PharmaTher may explore applications in mental health conditions, including treatment-resistant depression, suicidality, and PTSD.