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PharmaTher Holdings Ltd. (OTCQB: PHRRF, CSE: PHRM) generates news centered on its ketamine-focused pharmaceutical programs, drug delivery platforms, and related asset monetization activities. Company announcements describe a specialty pharmaceutical and life sciences business focused on unlocking the pharmaceutical and therapeutic potential of ketamine, psychedelics, and GLP-1 drugs, particularly for neuropsychiatric, mental health, pain, neurological, and obesity-related disorders.
News updates cover several recurring themes. One major area is the development of ketamine-based therapies, including a program for levodopa-induced dyskinesia in Parkinson's disease (LID-PD) that the company is preparing to advance under the FDA 505(b)(2) pathway toward a Phase 3 strategy. Releases describe regulatory planning, prior Phase I/II data, intellectual property coverage, and discussions with potential pharmaceutical partners. Another frequent topic is the evolution of a long-acting injectable ketamine franchise under an exclusive evaluation and option-to-license agreement with Oakwood Laboratories, which is intended to address neuropsychiatric indications such as treatment-resistant depression and major depressive disorders.
PharmaTher also issues news about its PharmaPatch™ microneedle patch platform, including initiatives to deliver ketamine, psychedelic compounds, and GLP-1 drugs, and its expansion into GLP-1 therapies for the potential treatment of obesity. Additional updates highlight the Digital Health AI division, featuring KetaVault™ and KetAImine™, which are presented as ketamine data and AI discovery platforms designed to generate new indications and combination programs.
Corporate communications further report on the FDA-approved ketamine ANDA, its sale to a sterile-injectables partner with milestone and profit-sharing economics, and the company's broader asset strategy, including its 49% equity interest in Sairiyo Therapeutics Inc. Investors and observers who follow PHRRF news can use this page to review company statements on clinical plans, regulatory interactions, partnering discussions, and platform expansions as disclosed in official releases.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported a total of $12.12 million in cash and investments as of May 31, 2022, fully funding its ketamine-based development programs for mental health and pain disorders.
The company aims for FDA approval of its ketamine injection and infusion products by 2H-2023. Key milestones include results from a Phase 2 clinical trial for ALS and potential Phase 3 trials for Parkinson’s disease. The firm is also pursuing partnerships for its innovative delivery systems.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) shared results from a Phase 1/2 clinical study of ketamine for treating levodopa-induced dyskinesia in Parkinson's disease at the MDS International Congress. The study showed that 100% of participants experienced a reduction in dyskinesias, with UDysRS scores decreasing by 51% at infusion, 49% at three weeks, and 41% at three months. The company plans a Phase 3 study to seek FDA approval under the 505(b)(2) pathway. Additionally, a patent for ketamine's potential use in Parkinson's treatment has been allowed by the USPTO.
PharmaTher Holdings Ltd. announced positive results from its IND-enabling pharmacokinetic study of the KETARX™ Ketamine Patch, demonstrating successful delivery of ketamine over 40 hours. The study, conducted under Good Laboratory Practice compliance, showed that the patch was well tolerated and allowed for increased dosage flexibility. PharmaTher plans to initiate phase 2 and 3 clinical studies by the end of Q4-2022 targeting mental health, PTSD, and pain management, following the FDA's 505(b)(2) regulatory pathway for approval.
PharmaTher (OTCQB: PHRRF) announced a Notice of Allowance from the USPTO for its patent on ketamine's use in treating motor disorders, including Parkinson’s Disease. This patent enhances their intellectual property and commercial prospects. The company plans to advance to a Phase 3 clinical study following successful results from a dose-finding study for levodopa-induced dyskinesia, showing 100% efficacy in reducing dyskinesias. The global Parkinson’s market is projected to grow to $7.5 billion by 2025, presenting significant financial potential for PharmaTher's ketamine treatment.
PharmaTher Holdings Ltd. has successfully completed a study on its patented microneedle patch, PHARMAPATCH™, for delivering ketamine and KETABET™. This breakthrough aims to mitigate side effects linked to traditional ketamine delivery methods. The patch showed promising results in animal studies, achieving sustained plasma concentrations of ketamine. The company plans to initiate Phase 2 clinical studies for treatment-resistant depression and chronic pain, and is currently preparing for upcoming GLP pre-clinical studies. PHARMAPATCH™ offers a de-risked, transdermal solution for patients.
PharmaTher Holdings Ltd. announced positive findings from an observational study on KETABET™, a drug combining FDA-approved ketamine and betaine anhydrous. The study revealed a significant 66% reduction in side effects like depersonalization and derealization associated with ketamine treatment for depression. The company plans to launch a Phase 2 clinical study using KETABET™ integrated into a microneedle patch, aiming to improve treatment compliance for various mental health disorders. Patent protection for KETABET™ is secured in multiple countries, expiring in 2036.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has partnered with CC Biotechnology Corporation to develop a wearable ketamine delivery device. This innovation aims to transition ketamine administration from traditional intravenous and intramuscular methods to a subcutaneous format, enhancing patient comfort and treatment adherence for mental health, neurological, and pain disorders. Clinical studies for the new device are expected to begin in Q1-2023. The partnership seeks to establish PharmaTher as a leader in specialty ketamine products, complementing its existing portfolio of injectable and microneedle patch solutions.
PharmaTher Holdings Ltd. announced the granting of US Patent No: 11,286,230 for a continuous-flow process technology for producing ketamine. This patent enhances PharmaTher's intellectual property portfolio, which includes novel uses and delivery systems for ketamine to address unmet medical needs in mental health and pain disorders. The company plans to develop its own Ketamine Injection and Infusion product, aiming for FDA submission in Q4-2022. This patent addresses inefficiencies in traditional ketamine production, improving yield and purity.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported a total of nearly $12 million in cash and investments as of February 28, 2022, ensuring full funding for ongoing development programs focused on ketamine products targeting mental health and pain disorders. Key highlights include progress towards FDA approval for KETARX™, a ketamine injection product, and successful clinical studies evaluating its microneedle patch and other formulations. The Company aims to lead in advancing ketamine therapeutics and plans to submit regulatory applications by the end of 2022.
PharmaTher Holdings Ltd. announced its plan to file ANDA and 505(b)(2) submissions with the FDA for innovative ketamine formulations aimed at mental health and neurological disorders. The company secured an exclusive license agreement with Gesval S.A. for a patented continuous-flow technology to enhance ketamine production efficiency. The company aims to launch its Ketamine Injection product and address various medical needs, including future pivotal studies for Parkinson's and ALS. Notably, PharmaTher's strategy includes partnerships for secure cGMP ketamine supply and novel dosage forms.