Latest news with #PharmaTher
Medscape
6 hours ago
- Business
- Medscape
FDA Okays Ketamine-Based Med for Post-Surgical Pain
The FDA has approved the racemic ketamine product known as KETARx (PharmaTher Holdings) for the treatment of post-surgical pain. 'This historic FDA approval…is a testament to years of dedicated development,' Fabio Chianelli, chairman and CEO of PharmaTher, said in a release. 'We remain steadfast in our mission to harness the pharmaceutical potential of ketamine for a range of mental health, neurological, and pain disorders,' he added. The company noted that it hopes to expand ketamine development into conditions such as Parkinson's disease, amyotrophic lateral sclerosis, depression, and complex regional pain syndrome. Its product has already received an orphan drug designation for the treatment of Rett syndrome. It added that, among psychedelic and 'psychedelic-adjacent' drugs, ketamine is the only one to be included on a list of Essential Medicines by the World Health Organization. The company initially announced that the FDA had set an approval goal date of April 2024 for KETARx. However, after 'minor deficiencies identified by Quality' were identified, the FDA assigned a new target date of October 2024. As reported by Medscape Medical News at the time, the FDA issued a complete response letter requesting additional information on the application. The final date of August 2025 was set after the company submitted the requested additional information.
Yahoo
11 hours ago
- Business
- Yahoo
PharmaTher Announces FDA Approval of Ketamine (KETARx(TM))
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 $750 million and projected to reach $3.42 billion by 2034, indicating a compound annual growth rate of 16.4%2. Furthermore, SPRAVATO® (esketamine), an FDA approved treatment for depression, is tracking a sales run rate of $1.6 billion, with guidance anticipating $3 billion to $3.5 billion by 2027-20283. This promising market outlook underscores the potential of KETARx™ and PharmaTher's strategic position in the industry. 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 ChianelliChief Executive OfficerPharmaTher Holdings 1-888-846-3171Email: info@ Website: 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 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: To view the source version of this press release, please visit
Toronto Star
11 hours ago
- Business
- Toronto Star
PharmaTher Announces FDA Approval of Ketamine (KETARx™)
TORONTO, Aug. 11, 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 announce today that the U.S. Food and Drug Administration (FDA) has approved 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.
Yahoo
12 hours ago
- Business
- Yahoo
PharmaTher Announces FDA Approval of Ketamine (KETARx™)
TORONTO, Aug. 11, 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 announce today that the U.S. Food and Drug Administration (FDA) has approved 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 $750 million and projected to reach $3.42 billion by 2034, indicating a compound annual growth rate of 16.4%2. Furthermore, SPRAVATO® (esketamine), an FDA approved treatment for depression, is tracking a sales run rate of $1.6 billion, with guidance anticipating $3 billion to $3.5 billion by 2027-20283. This promising market outlook underscores the potential of KETARx™ and PharmaTher's strategic position in the industry. 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 ChianelliChief Executive OfficerPharmaTher Holdings 1-888-846-3171Email: info@ Website: Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of 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 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
Ottawa Citizen
14-05-2025
- Business
- Ottawa Citizen
PharmaTher Unveils KetaVault™: A First-of-Its-Kind Portal to Accelerate Ketamine Research and Commercialization
Article content KetaVault™ to Provide Partners Unprecedented Access to PharmaTher's Extensive Regulatory, Manufacturing, and Clinical Ketamine Data, Aiming to Expedite New Therapies and Market Entry Article content Article content TORONTO, May 14, 2025 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the 'Company' or 'PharmaTher') (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the research and commercialization of ketamine for unmet medical needs, today announced the launch of KetaVault™. This innovative, world-first portal offers pharmaceutical and biotech companies, academic and clinical researchers, and government agencies to partner with PharmaTher for direct access to its comprehensive proprietary data on ketamine. KetaVault™ is strategically designed to streamline and accelerate clinical trials, regulatory submissions, and commercialization initiatives for ketamine-based therapies. Article content Article content The launch of KetaVault™ is strategically timed with the Company's anticipated FDA approval for its ketamine product, which has an approval goal date of June 4, 2025. This dual milestone underscores PharmaTher's commitment to leading innovation in the ketamine space. KetaVault™ is positioned to be a pivotal catalyst, empowering partners to leverage PharmaTher's deep expertise and data to unlock new therapeutic avenues for ketamine in areas of high unmet medical need and for emergency use applications, potentially revolutionizing treatment paradigms. Article content Fabio Chianelli, Chairman and CEO of PharmaTher, commented: 'PharmaTher is committed to revolutionizing patient care through ketamine. With KetaVault™, PharmaTher isn't just sharing data; we're igniting a new era of collaborative ketamine innovation. This platform is a bold step toward unlocking the full potential of ketamine, empowering our partners with unprecedented access to our years of dedicated work, rich proprietary insights, and collectively accelerating the journey towards novel treatments for patients in critical need. As we near our FDA approval goal date for ketamine, KetaVault™ will serve as a critical tool to expand ketamine's therapeutic reach and solidify PharmaTher's leadership in the market for ketamine, creating significant value for our partners and shareholders.' Article content Article content Expedited Regulatory Pathways: Leverage existing data to potentially streamline investigational new drug applications and emergency use authorizations. De-risked Clinical Development: Inform trial design, safety and efficacy data, and identify promising indications based on robust existing research. Enhanced Commercial Strategy: Gain insights into manufacturing, control, and product development for market readiness. Article content Regulatory Filings: Investigational New Drug (IND) Applications. Comprehensive Drug Information: Investigator's Brochures. Manufacturing Insights: Chemistry, Manufacturing, and Control (CMC) data. Clinical Research & Data: In-depth clinical study protocols and research data for indications including Parkinson's disease. Orphan Drug Designations: Access to information supporting FDA Orphan Drug Approvals for Amyotrophic Lateral Sclerosis, Rett Syndrome, Complex Regional Pain Syndrome, Status Epilepticus, and ischemia/reperfusion injury during solid organ transplantation. Novel Delivery Systems: Product development programs and regulatory filings for PharmaTher's ketamine microneedle patch and subcutaneous wearable pump.
