お知らせ • Jul 21
PharmaTher Holdings Ltd Announces Collaboration To Advance KetaMist Needle-Free Ketamine Treatment Toward FDA Approval
PharmaTher Holdings Ltd. announced a collaboration with Curtis W. Cassidy, M.D., the inventor and developer of KetaMist, a needle-free ketamine treatment platform, to pursue U.S. Food and Drug Administration approval for treatment-resistant depression and other neuropsychiatric and medical conditions where ketamine has demonstrated therapeutic benefit. KetaMist is a proprietary, patient-controlled and needle-free ketamine treatment platform developed for patients with treatment-resistant depression and other conditions. KetaMist has been used in more than 9,000 patient treatments, creating a meaningful body of real-world clinical experience that PharmaTher believes may support an efficient and potentially expedited FDA development strategy. Treatment-resistant depression represents a significant unmet medical need, affecting millions of patients in the United States who do not respond adequately to standard antidepressant therapies. The current FDA-approved ketamine-based therapy for treatment-resistant depression, Spravato (esketamine nasal spray), has demonstrated strong commercial traction, generating approximately $1.7 billion in worldwide sales in Fiscal year 2025, with trailing twelve-month sales through June 30, 2026 of approximately $2.0 billion. Analysts have reportedly projected that Spravato could generate approximately $3 billion in annual sales by 2027 and up to $5 billion in peak annual sales. PharmaTher believes KetaMist has the potential to compete in this large and growing market by offering a differentiated treatment approach that may address certain limitations associated with existing therapies. KetaMist is designed as a patient-controlled and needle-free delivery system, which may offer several potential advantages, subject to FDA approval: Personalized dosing and administration, allowing physicians to tailor treatment to individual patient response; Simplified delivery method, potentially improving patient comfort and accessibility; Potential for broader clinical adoption, depending on regulatory requirements and labeling; and Use of racemic ketamine, which may provide a differentiated pharmacological profile compared to esketamine. PharmaTher views KetaMist as a franchise platform with the potential to be developed across multiple indications where ketamine has already demonstrated clinical utility, including but not limited to depression, anxiety disorders, post-traumatic stress disorder, chronic pain, and other neuropsychiatric and neurological conditions. While many of these uses are currently off-label, PharmaTher believes KetaMist's flexible and personalized delivery approach may support expansion into additional therapeutic areas over time, subject to regulatory approval. PharmaTher and Dr. Cassidy plan to work with the FDA to find an efficient path to approval for KetaMist. Because ketamine is already an FDA-approved drug, the Company may be able to build on existing knowledge. KetaMist has already been used in more than 9,000 patient treatments, providing real-world experience on how the therapy is administered, how patients respond, and overall safety. PharmaTher will prepare regulatory documents to help guide discussions with the FDA toward a potentially expedited approval pathway. PharmaTher previously obtained FDA approval for Ketamine Hydrochloride Injection USP under ANDA #217858, demonstrating the Company's ability to complete the regulatory, manufacturing, analytical and quality requirements necessary to secure an FDA ketamine approval. Although PharmaTher completed its sale of its ANDA in December 2025, the Company retained its rights to pursue non-generic ketamine opportunities, including new formulations, delivery technologies and therapeutic indications. PharmaTher also retained significant regulatory and product-development experience generated through the successful ANDA program. As part of the KetaMist collaboration, PharmaTher intends to apply its ketamine regulatory, analytical and chemistry, manufacturing and controls experience to the KetaMist development program and seek FDA feedback on the most efficient pathway toward approval. The collaboration activities will include preparing an FDA meeting package to obtain guidance for a potentially accelerated path toward FDA approval. Near-term milestones are expected to include regulatory engagement with the FDA, definition of the clinical and data requirements for a potential NDA submission, and evaluation of how existing real-world data may support the development program. The collaboration agreement provides PharmaTher with a one-year evaluation period to assess KetaMist for potential development and commercial testing. During this period, the parties may negotiate and enter into one or more additional agreements relating to the further development and commercialization of KetaMist, subject to mutually acceptable terms. KetaMist is not currently approved by the FDA, and its existing clinical use is considered off-label. There can be no assurance that the FDA will accept the proposed regulatory pathway, that the existing treatment information will be suitable for regulatory use, or that KetaMist will receive FDA approval. KetaMist is a proprietary, patient-controlled and needle-free ketamine treatment platform developed to provide a more personalized approach for patients with treatment-resistant depression and other neuropsychiatric and medical conditions. The system is designed to allow physicians to tailor dosing and administration based on individual patient response, offering flexibility compared to traditional ketamine delivery methods. KetaMist has been used in more than 9,000 patient treatments, generating meaningful real-world clinical experience related to dosing, administration, safety observations and patient outcomes.
