PharmaTher Announces FDA Approval of Ketamine (KETARx(TM))
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 PharmaTher.com.
For more information about PharmaTher, please contact:Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: 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://iris.who.int/bitstream/handle/10665/371090/WHO-MHP-HPS-EML-2023.02-eng.pdf?sequence=1
https://www.factmr.com/report/injectable-ketamine-market
https://www.proactiveinvestors.com/companies/news/1075040/spravato-sales-momentum-underscores-market-potential-for-psychedelics-atai-life-sciences-seen-as-key-beneficiary-1075040.html?region=ca®ion=ca
https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine
https://www.politico.com/news/2025/06/29/rfk-psychedelics-ecstasy-ibogaine-veterans-00429997
https://rsds.org/the-veterans-health-administration-approves-and-pays-for-ketamine-infusions-for-retired-military/
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/262004
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The following FAQs were answered by Kai Burkhardt, this guide's writer and CNN Underscored's sustainability editor. Is bamboo toilet paper eco-friendly? Is bamboo toilet paper eco-friendly? Yes, bamboo toilet paper is eco-friendly. Bamboo is a much more sustainable option than toilet paper made from virgin wood pulp; however, the most eco-friendly alternative is recycled toilet paper. What is eco-friendly toilet paper? What is eco-friendly toilet paper? Normal toilet paper is made from trees that are cut down just to be flushed in your toilet. Eco-friendly toilet paper is made from either recycled paper or bamboo, both of which are more sustainable materials that have a smaller impact on the planet. CNN Underscored editors thoroughly test most of the products we cover and provide full transparency about how we test them. We have an experienced team of writers and editors with many years of testing experience who ensure each article is carefully edited and products are properly vetted. The writer of this story, Kai Burkhardt, is CNN Underscored's outdoors, pet and sustainability editor. For this guide, he acquired all the eco-friendly toilet paper mentioned in this story and tested the rolls himself. He performed standardized tests and also used them in day-to-day life to discover the best.
