PharmaTher Provides Corporate Update Following FDA Approval of Ketamine (KETARx™)

Rhea-AI Summary

PharmaTher (OTCQB: PHRRF) has provided a significant corporate update following FDA approval of KETARx™, its ketamine-based product for surgical and diagnostic anesthesia. The company is pursuing a dual-track commercialization strategy, targeting either a strategic partnership by Q4-2025 or a self-launch option.

The global ketamine injectable market is projected to grow from $725M (2024) to $3.42B (2034). PharmaTher holds five FDA orphan drug designations for ketamine and plans to submit a New Drug Application (NDA) for Complex Regional Pain Syndrome (CRPS) by Q4-2025, with an expected PDUFA date by Q4-2026. An additional rare disorder NDA is planned for Q1-2026.

The company is focusing exclusively on rare disorders through the FDA's 505(b)(2) pathway, leveraging orphan drug designations for market exclusivity and regulatory incentives.

Positive

• FDA approval secured for KETARx™ for surgical pain management
• Projected market growth from $725M (2024) to $3.42B (2034)
• Large addressable market with 50-55M U.S. surgical procedures annually
• Five FDA orphan drug designations secured for various indications
• Advanced discussions with specialty pharmaceutical partners for commercialization
• Potential 7-year market exclusivity and fee waivers for orphan indications

Negative

• Commercialization partnership not yet finalized
• Additional clinical data needed for CRPS New Drug Application
• No plans to pursue non-orphan/rare indications which limits market potential

Company advancing U.S. commercialization with FDA-approved ketamine and rare disorder NDA filings

TORONTO, Aug. 26, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to provide a corporate update highlighting commercial readiness for ketamine (KETARx™) and an ambitious regulatory program aimed at advancing KETARx™ for rare disorders.

Fabio Chianelli, Founder and CEO of PharmaTher, stated:

"With FDA approval for KETARx™ secured, our immediate priority is market entry, underpinned by a strong and efficient operational framework. We are also committed to broadening its therapeutic applications. Our strategy involves establishing a high-integrity ketamine franchise through a two-pronged approach: initially focusing on surgical and diagnostic anesthesia, then expanding into rare disorders leveraging ketamine's proven efficacy and safety and the FDA's increasing openness to real-world evidence and published data for drug approvals of rare disorders.”

With the recent FDA approval of KETARx™ for surgical pain management (anesthesia and sedation for surgical and diagnostic procedures), PharmaTher is executing a progressive plan to establish category leadership in the U.S. while advancing additional indications via the efficient 505(b)(2) pathway—particularly in rare disorders, where orphan-drug incentives and real-world evidence (RWE) can accelerate timelines.

Ketamine: A Transformative Opportunity

Numerous positive trends for ketamine are converging to offer unprecedented growth opportunities in both the near and medium terms, positioning PharmaTher at the forefront of ketamine’s evolution:

• Large addressable market: Global ketamine injectable market projected to expand from $725M (2024) to $3.42B (2034)¹.
• Sizeable, durable demand: ~50–55M U.S. surgical procedures and 23–24M diagnostic procedures annually utilize anesthesia/sedation—high-value access points for KETARx™^2-7.
• Growing macro factors: The increasing number of surgical & diagnostic procedures requiring anesthesia, driven by an aging population, rising chronic diseases, and novel surgical techniques, creates a robust demand for KETARx™.
• Clinical advantages: Ketamine’s well-known physiological and opioid-sparing profile.
• Quality & supply security: Ongoing quality and labelling concerns with compounded ketamine and potential supply blocks from the FDA underscore the need for FDA-approved, standardized products like KETARx™.
• Expanding reimbursement landscape: Broader medical community acceptance and growing coverage in psychiatry and pain expand ketamine’s long-term utility.
• Favorable regulatory environment: FDA increasing openness to real-world evidence and published data—especially for rare diseases—supports a fast-follower strategy under 505(b)(2) pathway.
  

Commercialization: Fast-Track to U.S. Market Leadership

Building on the momentum of FDA approval, PharmaTher is actively implementing a comprehensive commercialization strategy for KETARx™ in the U.S. market. This strategy, designed for sustainable growth, prioritizes both strategic partnerships and robust self-launch capabilities to ensure broad market access and capitalize on the significant opportunities within surgical and diagnostic anesthesia, while providing freedom to expand to exclusive new indications.

• Partnership pathway: PharmaTher is in advanced discussions with specialty pharmaceutical partners with commercial expertise in pain management and injectables. The Company anticipates a definitive agreement on or before Q4-2025 to accelerate U.S. and select international launches.
  
• Dual-track launch readiness: If a definitive agreement does not materialize on that timeline, PharmaTher will self-launch, leveraging established manufacturing and commercial partners.
  
• Channel build-out underway: Active discussions with leading and specialty drug wholesalers to supply hospitals, specialty clinics, government institutions, and clinical research.
  

Furthermore, the Company is in separate, promising initial discussions on potential development partnerships for its ketamine-based clinical stage programs, including for Parkinson’s disease, further expanding PharmaTher's pipeline and future revenue streams.

Capitalizing on New FDA Initiatives for Orphan Drugs: A Pipeline of Exclusive Opportunities

PharmaTher is strategically pursuing additional FDA approvals for KETARx™ to address rare disorders. Leveraging recent FDA drug approval initiatives for rare diseases, the Company’s robust orphan drug portfolio, and the successful FDA approval of KETARx™, the Company intends to submit literature-based New Drug Applications (NDA). This will be accomplished via the expedited 505(b)(2) pathway, which utilizes existing data to potentially accelerate approval timelines and require limited to no new efficacy-based studies.

PharmaTher holds five FDA orphan drug designations for ketamine, each representing a distinct opportunity for market exclusivity and significant patient impact:

1. Amyotrophic lateral sclerosis (approved on 08/03/2021)
2. Complex Regional Pain Syndrome (approved on 10/12/2021)
3. Status Epilepticus (approved on 01/31/2022)
4. Ischemia/reperfusion injury during solid organ transplantation (approved on 12/14/2022)
5. Rett Syndrome (approved on 02/01/2023)
   

Lead NDA program: Complex Regional Pain Syndrome

Following a meeting with the FDA regarding a potential New Drug Application (NDA) for ketamine in Complex Regional Pain Syndrome (CRPS) via the 505(b)(2) pathway and further consultation with its regulatory advisors, PharmaTher now has a better understanding of the FDA's approval requirements. The Company is therefore gathering relevant clinical data and securing exclusive rights to this essential data to support an NDA for a narrowly defined, short-term use of ketamine for CRPS. The Chemistry, Manufacturing, and Controls (CMC) section of this NDA will be strongly supported by the recently approved ketamine product, KETARx™. The Company expects to submit this NDA to the FDA by the end of Q4-2025, with hopes for a Prescription Drug User Fee Act (PDUFA) date by Q4-2026.

With orphan drug designation for CRPS, KETARx™ would qualify for substantial benefits and incentives, including seven years of marketing exclusivity, potential tax credits, exemption of post-approval fees, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million – significantly enhancing the value for this program.

Additionally, PharmaTher plans to submit another NDA for KETARx™ to treat a different rare disorder by Q1-2026; details will be released closer to the filing to maintain competitive advantage.

No Plans for Seeking FDA Approval for Non-Orphan/Rare Indications for Ketamine

The Company currently has no plans to pursue non-orphan/rare indications for KETARx™. PharmaTher is strategically focused on advancing ketamine for rare disorders under the FDA’s 505(b)(2) pathway with Orphan Drug Designation, which provides seven years of market exclusivity, fee waivers, and other regulatory incentives. Unlike common indications (e.g., depression), where reliance solely on published literature would not secure market exclusivity and any new label expansion would ultimately flow to all ketamine ANDA holders, such as PharmaTher, orphan indications offer a durable competitive advantage. By targeting rare disorders with high unmet medical need, PharmaTher is positioned to create meaningful exclusivity, protect market share, and unlock long-term value for patients and shareholders.

The Company will continue to provide timely updates on its commercial and regulatory progress, inviting shareholders, prospective investors and partners to subscribe to the press release email list and access the latest corporate presentation on pharmather.com.

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. The Company’s strategy combines regulatory efficiency, manufacturing quality, and commercial execution to deliver durable, capital-efficient growth. 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.factmr.com/report/injectable-ketamine-market
2. https://hcup-us.ahrq.gov/reports/statbriefs/sb281-Operating-Room-Procedures-During-Hospitalization-2018.jsp
3. https://www.ncbi.nlm.nih.gov/books/NBK577044/
4. https://catalog.data.gov/dataset/hcup-nationwide-ambulatory-surgery-sample-nass-database-restricted-access
5. https://orthospinenews.com/2023/08/16/ambulatory-surgical-center-market-is-expected-to-hit-usd-152600-million-by-2030/
6. https://www.endoscopy-campus.com/en/ec-news/u-s-gi-endoscopy-volumes-biggest-change-is-increases-in-upper-endoscopic-ultrasound/
7. https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/burden-of-digestive-diseases-in-united-states/indications-outcomes-gastrointestinal-endoscopy
   

FAQ

What is the FDA approval status of PharmaTher's KETARx™?

KETARx™ has received FDA approval for surgical pain management, specifically for anesthesia and sedation in surgical and diagnostic procedures.

What is the market potential for PharmaTher's ketamine injectable product?

The global ketamine injectable market is projected to grow from $725M in 2024 to $3.42B by 2034, with an addressable market of 50-55M U.S. surgical procedures annually.

What are PharmaTher's (PHRRF) commercialization plans for KETARx™?

PharmaTher is pursuing a dual-track strategy: seeking strategic partnerships with specialty pharmaceutical companies by Q4-2025 while maintaining self-launch capabilities as a backup option.

How many orphan drug designations does PharmaTher hold for ketamine?

PharmaTher holds five FDA orphan drug designations for ketamine, including treatments for ALS, Complex Regional Pain Syndrome, Status Epilepticus, Ischemia/reperfusion injury, and Rett Syndrome.

When will PharmaTher submit its NDA for Complex Regional Pain Syndrome?

PharmaTher plans to submit the NDA for CRPS by the end of Q4-2025, with an expected PDUFA date by Q4-2026.

What regulatory pathway is PharmaTher using for rare disorder approvals?

PharmaTher is using the FDA's 505(b)(2) pathway for rare disorders, which allows use of existing data to potentially accelerate approval timelines with limited to no new efficacy-based studies required.