PharmaTher Founder and CEO Issues Letter to Shareholders following the FDA Approval of Ketamine (KETARx™)
PharmaTher Holdings (OTCQB: PHRRF) has achieved a significant milestone with FDA approval of KETARx™, their ketamine product for surgical pain management. In a letter to shareholders, CEO Fabio Chianelli announced immediate plans for U.S. commercialization and international expansion.
The company is pursuing a dual strategy: advancing their own commercial launch while engaging in partnership discussions with specialty pharmaceutical companies. Their sales strategy targets hospitals, specialty clinics, and government institutions including the U.S. Department of Defense and Veterans Health Administration.
Beyond surgical applications, PharmaTher is developing ketamine-based treatments for Parkinson's disease, ALS, Complex Regional Pain Syndrome, and various mental health conditions through a ketamine patch and wearable pump system.
PharmaTher Holdings (OTCQB: PHRRF) ha raggiunto un traguardo significativo con l'approvazione da parte della FDA di KETARx™, il loro prodotto a base di ketamina per la gestione del dolore chirurgico. In una lettera agli azionisti, l'amministratore delegato Fabio Chianelli ha annunciato piani immediati per la commercializzazione negli Stati Uniti e per l'espansione internazionale.
L'azienda adotta una strategia duplice: avanzare con il proprio lancio commerciale e, contemporaneamente, avviare trattative di partnership con società farmaceutiche specializzate. La strategia di vendita è rivolta a ospedali, cliniche specialistiche e istituzioni governative, inclusi il Dipartimento della Difesa degli Stati Uniti e la Veterans Health Administration.
Oltre agli impieghi chirurgici, PharmaTher sta sviluppando terapie a base di ketamina per morbo di Parkinson, SLA, sindrome da dolore regionale complessa e varie condizioni di salute mentale attraverso un cerotto alla ketamina e un sistema di pompa indossabile.
PharmaTher Holdings (OTCQB: PHRRF) ha logrado un hito importante con la aprobación por la FDA de KETARx™, su producto de ketamina para el manejo del dolor quirúrgico. En una carta a los accionistas, el CEO Fabio Chianelli anunció planes inmediatos para la comercialización en EE. UU. y la expansión internacional.
La compañía sigue una estrategia dual: avanzar con su propio lanzamiento comercial mientras mantiene conversaciones de asociación con farmacéuticas especializadas. Su estrategia de ventas se dirige a hospitales, clínicas especializadas e instituciones gubernamentales, incluidos el Departamento de Defensa de EE. UU. y la Veterans Health Administration.
Más allá de las aplicaciones quirúrgicas, PharmaTher está desarrollando tratamientos basados en ketamina para enfermedad de Parkinson, ELA, síndrome de dolor regional complejo y diversas condiciones de salud mental mediante un parche de ketamina y un sistema de bomba wearable.
PharmaTher Holdings (OTCQB: PHRRF)가 수술 통증 관리를 위한 케타민 제품 KETARx™에 대해 미국 FDA 승인을 받으며 중요한 이정표를 달성했습니다. CEO 파비오 키아넬리(Fabio Chianelli)는 주주 서한에서 미국 내 상용화와 국제적 확장을 즉시 추진할 계획이라고 밝혔습니다.
회사는 자체 상용 출시에 박차를 가하는 한편 전문 제약사들과의 파트너십 논의도 병행하는 이중 전략을 추구하고 있습니다. 판매 전략은 병원, 전문 클리닉 및 정부 기관(미국 국방부와 재향군인 의료관리청 Veterans Health Administration 포함)을 주요 대상으로 합니다.
수술 분야 외에도 PharmaTher는 케타민 패치와 착용형 펌프 시스템을 통해 파킨슨병, 근위축성 측삭경화증(ALS), 복합 국소 통증 증후군 및 다양한 정신 건강 질환에 대한 케타민 기반 치료제를 개발하고 있습니다.
PharmaTher Holdings (OTCQB: PHRRF) a franchi une étape importante avec l'approbation par la FDA de KETARx™, son produit à base de kétamine pour la prise en charge de la douleur chirurgicale. Dans une lettre aux actionnaires, le PDG Fabio Chianelli a annoncé des plans immédiats de commercialisation aux États-Unis et d'expansion internationale.
L'entreprise suit une double stratégie : lancer sa propre commercialisation tout en menant des discussions de partenariat avec des sociétés pharmaceutiques spécialisées. Sa stratégie commerciale cible hôpitaux, cliniques spécialisées et institutions gouvernementales, y compris le département de la Défense des États-Unis et la Veterans Health Administration.
Au-delà des applications chirurgicales, PharmaTher développe des traitements à base de kétamine pour la maladie de Parkinson, la SLA, le syndrome douloureux régional complexe et diverses affections de santé mentale via un patch de kétamine et un système de pompe portable.
PharmaTher Holdings (OTCQB: PHRRF) hat einen bedeutenden Meilenstein erreicht: die FDA-Zulassung von KETARx™, ihrem Ketamin-Produkt zur Schmerzbehandlung bei chirurgischen Eingriffen. In einem Schreiben an die Aktionäre kündigte CEO Fabio Chianelli sofortige Pläne zur Kommerzialisierung in den USA und zur internationalen Expansion an.
Das Unternehmen verfolgt eine Doppelstrategie: den eigenen Markteintritt voranzutreiben und zugleich Partnerschaftsgespräche mit spezialisierten Pharmaunternehmen zu führen. Die Vertriebsstrategie richtet sich an Krankenhäuser, Fachkliniken und staatliche Einrichtungen, einschließlich des US-Verteidigungsministeriums und der Veterans Health Administration.
Über chirurgische Anwendungen hinaus entwickelt PharmaTher ketaminbasierte Therapien für Morbus Parkinson, ALS, das komplexe regionalisierte Schmerzsyndrom und verschiedene psychische Erkrankungen mittels eines Ketamin-Pflasters und eines tragbaren Pumpensystems.
- FDA approval received for KETARx™ for surgical pain management
- Multiple partnership discussions ongoing with specialty pharmaceutical companies
- Clear commercialization strategy targeting hospitals, clinics, and government institutions
- Pipeline includes treatments for multiple high-value indications via FDA's 505(b)(2) pathway
- Complex commercialization process with multiple moving parts to manage
- Significant competition expected in the ketamine therapeutics space
TORONTO, Aug. 14, 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, announced today that Fabio Chianelli, the Company’s Founder, Chairman and Chief Executive Officer, has issued the following letter to shareholders.
Dear Fellow Shareholders,
Earlier this year, I wrote to you about the challenges we faced with our FDA Priority Original Abbreviated New Drug Application for our ketamine product, which we have named KETARx™. I was thrilled to receive the FDA approval letter on Friday, August 8, 2025, for KETARx™, for its use in surgical pain management (anesthesia and sedation). We proudly announced this milestone on Monday, August 11, 2025.
This approval is more than just an achievement—it is a turning point. Our journey has been long, filled with determination, resilience, and belief in ketamine���s transformative potential. Now, we have not just seen the light at the end of the tunnel—we’ve stepped into it. With this success, a new era begins for PharmaTher, and I believe the opportunities ahead could be game-changing for PharmaTher, our shareholders, and most importantly, the millions of patients in need.
The Road Ahead – From Approval to Impact
We are moving swiftly into pre-launch commercialization of KETARx™ in the U.S. while also preparing international regulatory filings. Bringing a drug to market requires handling of many moving parts—marketing, sales, manufacturing, and global cost-optimization strategies, just to name a few. While this complexity is expected, the immediate surge of interest from specialty pharmaceutical companies—ranging from large to mid-sized industry players to niche innovators—has been nothing short of exhilarating.
Partnership discussions are already underway, but make no mistake—we are also advancing our commercial plan to launch KETARx™ this year. We have a clear and scalable sales channel targeting hospitals, specialty clinics, government institutions such as the U.S. Department of Defense and Veterans Health Administration, as well as clinical research programs and support for special or expanded access programs.
And this is only Phase One. Millions of surgical patients stand to benefit today, but the long-term potential for KETARx™ across other indications is vast.
Unlocking the Full Power of Ketamine
Our FDA approval reinforces our mission: to unlock the full pharmaceutical potential of ketamine for mental health, neurological, and pain disorders. I am especially excited about our clinical-stage programs, which include:
- Parkinson’s disease (treatment for levodopa-induced dyskinesia)
- Amyotrophic Lateral Sclerosis (ALS)
- Complex Regional Pain Syndrome (CRPS)
- A ketamine patch and wearable pump for diverse mental health and pain conditions
These programs fall under the FDA’s 505(b)(2) pathway, and with the current momentum in regulatory openness toward psychedelic-assisted therapies—plus potential fast-track opportunities—we believe the landscape for ketamine innovation is only improving.
While our immediate focus remains on KETARx™ commercialization, our discussions with potential partners include these pipeline programs, which could significantly expand our market reach and value creation.
From Vision to Reality
When I founded PharmaTher in April 2020, our vision was clear: be all-in on ketamine. That conviction has carried us through the highs and lows to this moment—FDA approval of our first ketamine product. This milestone isn’t just a win for us; it’s a validation of ketamine’s place as a transformative treatment option and a springboard into an entirely new chapter for the Company, unlocking an unprecedented array of opportunities that were once beyond our reach.
We are standing at the threshold of what I believe will be a new era in medicine—one where ketamine’s proven benefits can touch millions more lives worldwide. Our commitment is unwavering: to innovate, to grow, and to deliver on the promise of ketamine to transform global health outcomes.
With your continued support, I believe we will build PharmaTher into a leader in next-generation ketamine therapeutics—creating meaningful impact for patients, expanding globally, and unlocking the full potential of ketamine. The opportunities ahead are vast, the timing is perfect, and our determination has never been stronger.
PharmaTher is poised for an extraordinary next chapter.
Sincerely,
Fabio Chianelli
Founder, Chairman and CEO
PharmaTher Holdings Ltd.
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
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FAQ
What did PharmaTher (PHRRF) receive FDA approval for in August 2025?
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