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 (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.
PharmaTher (OTCQB: PHRRF) sta sviluppando un cerotto transdermico a base di ketamina come soluzione analgesica non oppioide, partendo dal suo prodotto endovenoso di ketamina recentemente approvato dalla FDA, KETARx™. L'azienda punta al mercato statunitense della gestione del dolore da 50 miliardi di dollari, che include 13 miliardi per il dolore postoperatorio acuto e 30 miliardi per le condizioni di dolore cronico.
Il cerotto a base di ketamina è pensato per fornire un'analgesia controllata e prolungata, sia per il dolore acuto che cronico, adatta a ospedali, strutture ambulatoriali e assistenza domiciliare. PharmaTher intende richiedere la partecipazione al Commissioner’s National Priority Voucher (CNPV) Pilot Program della FDA, che potrebbe consentire una revisione NDA accelerata in appena 1-2 mesi. Lo sviluppo è in linea con la priorità della FDA di affrontare l'epidemia di oppioidi, che ha causato oltre 80.000 decessi nel 2023.
PharmaTher (OTCQB: PHRRF) está avanzando en un parche transdérmico de ketamina como solución analgésica no opioide, basándose en su producto intravenoso de ketamina recientemente aprobado por la FDA, KETARx™. La compañía se dirige al mercado estadounidense de manejo del dolor de 50.000 millones de dólares, que incluye 13.000 millones en dolor postoperatorio agudo y 30.000 millones en condiciones de dolor crónico.
El parche de ketamina busca ofrecer analgesia controlada y sostenida para dolor agudo y crónico, adecuado para hospitales, atención ambulatoria y el hogar. PharmaTher planea solicitar participar en el Pilot Program Commissioner’s National Priority Voucher (CNPV) de la FDA, lo que podría permitir una revisión acelerada de la NDA en solo 1-2 meses. El desarrollo se alinea con la prioridad de la FDA de abordar la epidemia de opioides, que causó más de 80.000 muertes en 2023.
PharmaTher (OTCQB: PHRRF)은 비마약성 진통 솔루션으로서 케타민 경피 패치를 개발 중이며, 최근 FDA 승인된 정맥주사용 케타민 제품 KETARx™를 기반으로 하고 있습니다. 회사는 미국 진통 관리 시장 500억 달러를 목표로 하며, 여기에는 급성 수술 후 통증 분야의 130억 달러와 만성 통증 질환의 300억 달러가 포함됩니다.
케타민 패치는 급성 및 만성 통증에 대해 통제된 지속적 진통을 제공하도록 설계되었으며 병원, 외래 및 가정 치료 환경에 적합합니다. PharmaTher은 FDA의 Commissioner’s National Priority Voucher(CNPV) 파일럿 프로그램 참여를 추진할 계획이며, 이를 통해 NDA 심사가 단 1-2개월로 가속화될 가능성이 있습니다. 이 개발은 2023년에 80,000명 이상의 사망을 초래한 오피오이드 유행병 대응이라는 FDA의 우선순위와 부합합니다.
PharmaTher (OTCQB: PHRRF) fait progresser son patch transdermique de kétamine comme solution analgésique non opioïde, en s'appuyant sur son produit intraveineux de kétamine récemment approuvé par la FDA, KETARx™. La société vise le marché américain de la prise en charge de la douleur de 50 milliards de dollars, incluant 13 milliards pour la douleur postopératoire aiguë et 30 milliards pour les affections douloureuses chroniques.
Le patch de kétamine vise à fournir une analgésie contrôlée et soutenue pour la douleur aiguë et chronique, adaptée aux hôpitaux, aux structures ambulatoires et aux soins à domicile. PharmaTher prévoit de participer au programme pilote Commissioner’s National Priority Voucher (CNPV) de la FDA, ce qui pourrait permettre une révision NDA accélérée en seulement 1 à 2 mois. Ce développement s'aligne sur la priorité de la FDA de lutter contre l'épidémie d'opioïdes, qui a causé plus de 80 000 décès en 2023.
PharmaTher (OTCQB: PHRRF) entwickelt ein transdermales Ketaminpflaster als nicht-opioide Schmerztherapie und baut dabei auf seinem kürzlich von der FDA zugelassenen intravenösen Ketaminprodukt KETARx™ auf. Das Unternehmen zielt auf den 50-Milliarden-Dollar-US-Markt für Schmerzbehandlung ab, darunter 13 Milliarden für akute postoperative Schmerzen und 30 Milliarden für chronische Schmerzzustände.
Das Ketaminpflaster soll eine kontrollierte, anhaltende Analgesie bei akuten und chronischen Schmerzen bieten und ist für Krankenhaus-, ambulante und häusliche Versorgung geeignet. PharmaTher plant, das Commissioner’s National Priority Voucher (CNPV) Pilotprogramm der FDA zu beantragen, was eine beschleunigte NDA-Prüfung in nur 1–2 Monaten ermöglichen könnte. Die Entwicklung steht im Einklang mit der Priorität der FDA, die Opioid-Epidemie zu bekämpfen, die 2023 über 80.000 Todesfälle verursacht hat.
- 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
- 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
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:
- https://www.cdc.gov/overdose-prevention/about/index.html
- https://www.cdc.gov/nchs/fastats/inpatient-surgery.htm
- https://www.mordorintelligence.com/industry-reports/post-operative-pain-management-market
- https://www.futuremarketinsights.com/reports/postoperative-pain-market
- https://www.futuremarketinsights.com/reports/chronic-pain-market
- https://www.imarcgroup.com/chronic-pain-market
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/264087
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