PharmaTher Announces FDA Approval of Ketamine (KETARx(TM))

Rhea-AI Summary

PharmaTher Holdings (OTCQB: PHRRF) has received FDA approval for KETARx™, its ketamine product for surgical pain management, marking a significant milestone in the company's development. The approval positions PharmaTher to expand into various therapeutic areas including mental health, neurological disorders, and pain management.

The global ketamine market, currently valued at $750 million, is projected to reach $3.42 billion by 2034, with a CAGR of 16.4%. This growth potential is further validated by SPRAVATO®'s success, which is tracking a $1.6 billion sales run rate with guidance of $3-3.5 billion by 2027-2028.

The approval addresses the ongoing FDA drug shortage list issue for ketamine since February 2018, offering a reliable, high-quality supply source for various therapeutic applications.

Positive

• FDA approval received for KETARx™ for surgical pain management
• Strong market potential with global ketamine market projected to reach $3.42B by 2034
• Addresses ongoing FDA drug shortage list issue since February 2018
• Strategic positioning for expansion into multiple therapeutic areas
• Veterans Health Administration currently approves and funds ketamine treatments

Negative

• FDA issued compounding risk alert for ketamine products in psychiatric disorders
• Faces competition from established products like SPRAVATO® in certain markets

News Market Reaction

+8.33%

1 alert

+8.33% News Effect

On the day this news was published, PHRRF gained 8.33%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Toronto, Ontario--(Newsfile Corp. - August 11, 2025) -  PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce that it received the U.S. Food and Drug Administration (FDA) approval for the Company's ketamine product, herein referred to as KETARx™, on August 8^th, 2025, for its indicated uses in surgical pain management. This FDA approval signifies a momentous achievement for PharmaTher and strategically positions the Company to contribute to the psychedelic pharmaceutical revolution by leveraging its commercial and clinical initiatives with ketamine towards mental health, neurological, and pain disorders.

Fabio Chianelli, Founder, Chairman and CEO of PharmaTher, commented:

"Today marks a new chapter for PharmaTher. With FDA approval for ketamine now in hand, we are closer to realizing our goal of becoming a global leader in ketamine-based pharmaceuticals. This historic FDA approval for PharmaTher is a testament to years of dedicated development, signalling a new era of growth. We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders."

Ketamine stands out among psychedelic and psychedelic-adjacent drugs as the only one included on the World Health Organization's Model List of Essential Medicines¹. The global ketamine market is expected to experience substantial growth, currently valued at $750 million and projected to reach $3.42 billion by 2034, indicating a compound annual growth rate of 16.4%². Furthermore, SPRAVATO® (esketamine), an FDA approved treatment for depression, is tracking a sales run rate of $1.6 billion, with guidance anticipating $3 billion to $3.5 billion by 2027-2028³. This promising market outlook underscores the potential of KETARx™ and PharmaTher's strategic position in the industry.

The FDA's approval of the Company's ketamine product, KETARx™, provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas within the Company's product pipeline. These areas include mental health conditions like depression, neurological disorders such as Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS), and the management of rare or chronic pain, including Complex Regional Pain Syndrome (CRPS).

Since February 2018, ketamine has been regularly listed on the FDA drug shortage list, highlighting a significant need for a consistent, high-quality supply. This issue is cautioned by a compounding risk alert issued by the FDA on October 10, 2023⁴, which detailed potential risks associated with compounded ketamine products used for psychiatric disorders. Robert F. Kennedy Jr., Secretary of Health and Human Services, has also emphasized the importance of expanding research and ensuring legal access to psychedelic therapies for veterans⁵. The Veterans Health Administration, the largest integrated healthcare system in the U.S., currently approves and funds ketamine infusions for retired military personnel afflicted with depression, PTSD, and chronic pain⁶. Furthermore, FDA Commissioner Marty Makary's establishment of the Commissioner's National Priority Voucher program signifies the FDA's dedication to expediting access to safe and effective treatments, instilling confidence in potential future regulatory support and accessibility for ketamine.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on unlocking the pharmaceutical potential of Ketamine (KETARx™) for mental health, neurological, and pain disorders. 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://iris.who.int/bitstream/handle/10665/371090/WHO-MHP-HPS-EML-2023.02-eng.pdf?sequence=1
2. https://www.factmr.com/report/injectable-ketamine-market
3. https://www.proactiveinvestors.com/companies/news/1075040/spravato-sales-momentum-underscores-market-potential-for-psychedelics-atai-life-sciences-seen-as-key-beneficiary-1075040.html?region=ca&region=ca
4. https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine
5. https://www.politico.com/news/2025/06/29/rfk-psychedelics-ecstasy-ibogaine-veterans-00429997
6. https://rsds.org/the-veterans-health-administration-approves-and-pays-for-ketamine-infusions-for-retired-military/

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/262004

FAQ

What did PharmaTher (PHRRF) receive FDA approval for in August 2025?

PharmaTher received FDA approval for KETARx™, its ketamine product, specifically for surgical pain management applications on August 8th, 2025.

What is the market size projection for ketamine by 2034?

The global ketamine market is projected to grow from $750 million currently to $3.42 billion by 2034, representing a compound annual growth rate of 16.4%.

What therapeutic areas will PharmaTher's KETARx™ target?

KETARx™ targets multiple therapeutic areas including mental health conditions (depression), neurological disorders (Parkinson's disease and ALS), and pain management (Complex Regional Pain Syndrome).

How does the FDA drug shortage situation affect PharmaTher's ketamine approval?

Ketamine has been on the FDA drug shortage list since February 2018, making PharmaTher's FDA-approved KETARx™ significant as a new, reliable source of high-quality ketamine supply.

What is the Veterans Health Administration's stance on ketamine treatments?

The Veterans Health Administration approves and funds ketamine infusions for retired military personnel treating depression, PTSD, and chronic pain.