PharmaTher Announces FDA Approval of Ketamine (KETARx(TM))
PharmaTher Holdings (OTCQB: PHRRF) has received FDA approval for 碍贰罢础搁虫鈩�, 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庐'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.
PharmaTher Holdings (OTCQB: PHRRF) ha ottenuto l'approvazione FDA per 碍贰罢础搁虫鈩�, il suo prodotto a base di ketamina per la gestione del dolore chirurgico, segnando una tappa importante nello sviluppo dell'azienda. L'approvazione pone PharmaTher nella condizione di espandersi in diverse aree terapeutiche, tra cui salute mentale, disturbi neurologici e gestione del dolore.
Il mercato globale della ketamina, attualmente valutato $750 milioni, 猫 previsto raggiungere $3,42 miliardi entro il 2034, con un CAGR del 16,4%. Questo potenziale di crescita 猫 ulteriormente confermato dal successo di SPRAVATO庐, che mostra un run rate di vendite di $1,6 miliardi e una guidance di $3鈥�3,5 miliardi per il 2027鈥�2028.
L'approvazione contribuisce a fronteggiare la carenza di ketamina inserita nella lista FDA a partire da febbraio 2018, offrendo una fonte affidabile e di alta qualit脿 per varie applicazioni terapeutiche.
PharmaTher Holdings (OTCQB: PHRRF) ha recibido la aprobaci贸n de la FDA para 碍贰罢础搁虫鈩�, su producto de ketamina para el manejo del dolor quir煤rgico, marcando un hito importante en el desarrollo de la compa帽铆a. La aprobaci贸n sit煤a a PharmaTher en posici贸n de expandirse a varias 谩reas terap茅uticas, incluidas la salud mental, los trastornos neurol贸gicos y el manejo del dolor.
El mercado global de ketamina, actualmente valorado en $750 millones, se proyecta que alcanzar谩 $3,42 mil millones para 2034, con un CAGR del 16,4%. Este potencial de crecimiento se ve reforzado por el 茅xito de SPRAVATO庐, que presenta un run rate de ventas de $1,6 mil millones y una gu铆a de $3鈥�3,5 mil millones para 2027鈥�2028.
La aprobaci贸n contribuye a abordar la escasez de ketamina incluida en la lista de la FDA desde febrero de 2018, ofreciendo una fuente fiable y de alta calidad para diversas aplicaciones terap茅uticas.
PharmaTher Holdings (OTCQB: PHRRF)臧� 鞕戈臣鞝� 韱奠 甏�毽毄 旒�韮�氙� 鞝滍拡鞚� 碍贰罢础搁虫鈩㈧棎 雽�頃� FDA 鞀轨澑鞚� 氚涭晞 須岇偓 氚滌爠鞐� 鞛堨柎 欷戩殧頃� 鞚挫爼響滊ゼ 靹胳洜鞀惦媹雼�. 鞚措矆 鞀轨澑鞚� PharmaTher臧� 鞝曥嫚 瓯搓皶, 鞁犼步瓿� 歆堩櫂 氚� 韱奠 甏�毽� 霌� 雼れ枒頃� 旃橂 攵勳暭搿� 頇曥灔頃� 靾� 鞛堧姅 氚滍寪鞚� 鞝滉车頃╇媹雼�.
鞝� 靹戈硠 旒�韮�氙� 鞁滌灔鞚� 順勳灛 $750 million 攴滊搿� 韽夑皜霅橂┌, 鞐绊弶攴� 靹膘灔毳�(CAGR) 16.4%搿� 2034雲勱箤歆� $3.42 billion鞐� 鞚措ゼ 瓴冹溂搿� 鞓堨儊霅╇媹雼�. 鞚措煬頃� 靹膘灔 鞛犾灛霠レ潃 SPRAVATO庐鞚� 靹标车鞙茧霃� 鞛呾霅橂姅雿�, 頃措嫻 鞝滍拡鞚� 順勳灛 $1.6 billion 毵れ稖 霟半爤鞚错姼毳� 旮半 欷戩澊氅� 2027鈥�2028雲勱箤歆� $3鈥�3.5 billion鞚� 氇╉憸搿� 頃橁碃 鞛堨姷雼堧嫟.
鞚措矆 鞀轨澑鞚� 2018雲� 2鞗旊秬韯� 瓿勳啀霅� FDA鞚� 旒�韮�氙� 頀堧 攵�臁� 氍胳牅毳� 頃挫唽頃橂姅 雿� 旮办棳頃橂┌, 雼れ枒頃� 旃橂 鞚戩毄鞐� 鞁犽頃� 靾� 鞛堦碃 瓿犿拡歆堨潣 瓿店笁鞗愳潉 鞝滉车頃╇媹雼�.
PharmaTher Holdings (OTCQB: PHRRF) a obtenu l'approbation de la FDA pour 碍贰罢础搁虫鈩�, son produit 脿 base de k茅tamine destin茅 脿 la prise en charge de la douleur chirurgicale, marquant une 茅tape majeure dans le d茅veloppement de l'entreprise. Cette approbation permet 脿 PharmaTher de se d茅velopper dans plusieurs domaines th茅rapeutiques, notamment la sant茅 mentale, les troubles neurologiques et la gestion de la douleur.
Le march茅 mondial de la k茅tamine, actuellement estim茅 脿 750 millions $, devrait atteindre 3,42 milliards $ d'ici 2034, avec un taux de croissance annuel compos茅 (TCAC) de 16,4 %. Ce potentiel de croissance est renforc茅 par le succ猫s de SPRAVATO庐, qui affiche un run rate des ventes de 1,6 milliard $ et des pr茅visions de 3鈥�3,5 milliards $ pour 2027鈥�2028.
Cette approbation contribue 脿 rem茅dier 脿 la p茅nurie de k茅tamine figurant sur la liste de la FDA depuis f茅vrier 2018, en offrant une source d'approvisionnement fiable et de haute qualit茅 pour diverses applications th茅rapeutiques.
PharmaTher Holdings (OTCQB: PHRRF) hat die FDA-Zulassung f眉r 碍贰罢础搁虫鈩�, sein Ketaminprodukt zur Behandlung von chirurgischen Schmerzen, erhalten und damit einen bedeutenden Meilenstein erreicht. Die Zulassung erm枚glicht PharmaTher die Ausweitung in verschiedene Therapiegebiete, darunter psychische Gesundheit, neurologische St枚rungen und Schmerzbehandlung.
Der globale Ketaminmarkt, derzeit mit $750 Millionen bewertet, soll bis 2034 auf $3,42 Milliarden anwachsen, bei einer j盲hrlichen Wachstumsrate (CAGR) von 16,4%. Dieses Wachstumspotenzial wird durch den Erfolg von SPRAVATO庐 gest眉tzt, das einen $1,6 Milliarden Umsatz-Runrate aufweist und eine Prognose von $3鈥�3,5 Milliarden f眉r 2027鈥�2028 nennt.
Die Zulassung tr盲gt zur L枚sung des seit Februar 2018 bestehenden FDA-Engpasses bei Ketamin bei und bietet eine verl盲ssliche, qualitativ hochwertige Versorgung f眉r verschiedene therapeutische Anwendungen.
- FDA approval received for 碍贰罢础搁虫鈩� 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
- FDA issued compounding risk alert for ketamine products in psychiatric disorders
- Faces competition from established products like SPRAVATO庐 in certain markets
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 8th, 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
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 .
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: [email protected]
Website:
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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 .
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FAQ
What did PharmaTher (PHRRF) receive FDA approval for in August 2025?
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What is the Veterans Health Administration's stance on ketamine treatments?
