PharmaTher Announces FDA Approval of Ketamine (KETARx鈩�)
PharmaTher Holdings (OTCQB: PHRRF) has achieved a significant milestone with the FDA approval of KETARx鈩�, its ketamine product for surgical pain management, on August 8th, 2025. This approval positions PharmaTher strategically in the rapidly growing ketamine market, currently valued at $750 million and projected to reach $3.42 billion by 2034, with a CAGR of 16.4%.
The approval enables PharmaTher to expand ketamine development across various therapeutic areas, including depression, Parkinson's disease, ALS, and Complex Regional Pain Syndrome (CRPS). Notably, ketamine has been on the FDA drug shortage list since February 2018, highlighting the significant market opportunity for a consistent, high-quality supply.
PharmaTher Holdings (OTCQB: PHRRF) ha raggiunto un importante traguardo con la approvazione da parte della FDA di KETARx鈩�, il suo prodotto a base di ketamina per la gestione del dolore chirurgico, l'8 agosto 2025. Questa approvazione posiziona PharmaTher in modo strategico nel mercato della ketamina in rapida crescita, attualmente valutato $750 milioni e previsto raggiungere $3,42 miliardi entro il 2034, con un CAGR del 16,4%.
L'approvazione permette a PharmaTher di ampliare lo sviluppo della ketamina in diversi ambiti terapeutici, tra cui depressione, morbo di Parkinson, sclerosi laterale amiotrofica (ALS) e sindrome del dolore regionale complesso (CRPS). 脠 rilevante che la ketamina sia nella lista dei farmaci in carenza della FDA dal febbraio 2018, sottolineando l'opportunit脿 di mercato per un approvvigionamento costante e di alta qualit脿.
PharmaTher Holdings (OTCQB: PHRRF) ha alcanzado un hito importante con la aprobaci贸n por la FDA de KETARx鈩�, su producto de ketamina para el manejo del dolor quir煤rgico, el 8 de agosto de 2025. Esta aprobaci贸n sit煤a a PharmaTher estrat茅gicamente en el mercado de la ketamina, de r谩pido crecimiento, actualmente valorado en $750 millones y proyectado a alcanzar $3.42 mil millones para 2034, con un CAGR del 16,4%.
La aprobaci贸n permite a PharmaTher ampliar el desarrollo de la ketamina en diversas 谩reas terap茅uticas, incluidas depresi贸n, enfermedad de Parkinson, ELA (ALS) y S铆ndrome de Dolor Regional Complejo (CRPS). Cabe destacar que la ketamina figura en la lista de escasez de f谩rmacos de la FDA desde febrero de 2018, lo que resalta la oportunidad de mercado para un suministro constante y de alta calidad.
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鞚措矆 鞀轨澑鞚� 韱淀暣 PharmaTher電� 鞖办毟歃�, 韺岉偍鞀硲, ALS(攴检渼於曥劚 旄§偔瓴巾檾歃�), 氤淀暕攵�鞙勴喌歃濎頉勱蛋(CRPS) 霌� 雼れ枒頃� 旃橂 攵勳暭搿� 旒�韮�氙� 臧滊皽鞚� 頇曥灔頃� 靾� 鞛堦矊 霅╇媹雼�. 韸鬼瀳 旒�韮�氙检潃 2018雲� 2鞗旊秬韯� FDA鞚� 鞎诫 攵�臁� 氇╇鞐� 韽暔霅橃柎 鞛堧嫟電� 鞝愳棎靹�, 鞎堨爼鞝侅澊瓿� 瓿犿拡歆堨潣 瓿店笁鞐� 雽�頃� 韥� 鞁滌灔 旮绊殞毳� 鞁滌偓頃╇媹雼�.
PharmaTher Holdings (OTCQB: PHRRF) a atteint une 茅tape importante avec l'approbation par la FDA de KETARx鈩�, son produit 脿 base de k茅tamine pour la prise en charge de la douleur chirurgicale, le 8 ao没t 2025. Cette approbation positionne PharmaTher de mani猫re strat茅gique sur le march茅 de la k茅tamine en forte croissance, actuellement 茅valu茅 脿 750 millions de dollars et pr茅vu d'atteindre 3,42 milliards de dollars d'ici 2034, avec un TCAC de 16,4 %.
Cette validation permet 脿 PharmaTher d'茅tendre le d茅veloppement de la k茅tamine 脿 plusieurs domaines th茅rapeutiques, notamment la d茅pression, la maladie de Parkinson, la SLA (scl茅rose lat茅rale amyotrophique) et le syndrome douloureux r茅gional complexe (CRPS). Il est notable que la k茅tamine figure sur la liste des p茅nuries de m茅dicaments de la FDA depuis f茅vrier 2018, ce qui met en 茅vidence une importante opportunit茅 de march茅 pour un approvisionnement constant et de haute qualit茅.
PharmaTher Holdings (OTCQB: PHRRF) hat am 8. August 2025 mit der FDA-Zulassung von KETARx鈩�, seinem Ketaminprodukt zur Kontrolle von Operationsschmerzen, einen bedeutenden Meilenstein erreicht. Diese Zulassung positioniert PharmaTher strategisch im schnell wachsenden Ketaminmarkt, der derzeit mit $750 Millionen bewertet ist und bis 2034 voraussichtlich $3,42 Milliarden erreichen wird, bei einem CAGR von 16,4%.
Die Zulassung erm枚glicht es PharmaTher, die Ketamin-Entwicklung auf verschiedene therapeutische Bereiche auszuweiten, darunter Depression, Parkinson-Krankheit, ALS (amyotrophe Lateralsklerose) und das komplexe regionale Schmerzsyndrom (CRPS). Auff盲llig ist, dass Ketamin seit Februar 2018 auf der FDA-Liste der Arzneimittelengp盲sse steht, was die bedeutende Marktchance f眉r eine zuverl盲ssige, hochwertige Versorgung unterstreicht.
- FDA approval of KETARx鈩� for surgical pain management
- Strong market potential with ketamine market projected to reach $3.42B by 2034
- Addresses ongoing FDA drug shortage list issue since February 2018
- Strategic positioning in multiple therapeutic areas including mental health, neurological, and pain disorders
- Potential market opportunity highlighted by SPRAVATO庐 sales run rate of $1.6B
- Competitive market with established players like SPRAVATO庐
- FDA warning about risks associated with compounded ketamine products
- Complex regulatory landscape for psychedelic-based treatments
TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the 鈥淐ompany鈥� or 鈥淧harmaTher鈥�) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved the Company鈥檚 ketamine product, herein referred to as KETARx鈩�, 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:
鈥淭oday 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.鈥�
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鈥檚 ketamine product, KETARx鈩�, 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鈩�) 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:
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 鈥渃loser鈥�, "could", 鈥渃onfident鈥�, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", 鈥漰romise鈥�, 鈥渟trong鈥�, "aim", 鈥渕ay鈥�, 鈥減lan鈥�, 鈥減roposed鈥�, 鈥渓ead鈥�, 鈥渢oward鈥�, 鈥渁nticipate鈥�, 鈥減rovide鈥�, 鈥減osition鈥�, 鈥渓everage鈥�, 鈥渕itigate鈥�, 鈥渂efore鈥�, 鈥減rior鈥�, 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 .
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.
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FAQ
What is the significance of PharmaTher's FDA approval for KETARx鈩�?
What is the market potential for PharmaTher's ketamine product?
What therapeutic areas will PharmaTher's KETARx鈩� target?
How does PharmaTher (PHRRF) address the current ketamine shortage?
What are the potential applications of PharmaTher's ketamine in veterans' healthcare?
