PharmaTher Applauds FDA's New Commissioner’s National Priority Voucher (CNPV) Program, Citing Potential to Accelerate its Ketamine Programs for Mental Health, Pain, and Neurological Disorders, and National Security Applications

Core Insights - PharmaTher Holdings Ltd. is focused on developing ketamine-based therapies and supports the FDA's new Commissioner's National Priority Voucher (CNPV) program to expedite the regulatory review process for its products [1][2][7] - The CNPV program significantly reduces the review time for drug applications from approximately 10-12 months to 1-2 months, allowing for accelerated approval if legal requirements are met [2] - PharmaTher has a robust chemistry, manufacturing, and controls (CMC) package for its ketamine product, with an FDA approval goal date set for August 9, 2025 [3] Clinical Developments - The company has promising clinical data for its ketamine therapies targeting rare and near-rare disorders, including Parkinson's disease and Complex Regional Pain Syndrome [4] - PharmaTher is developing innovative delivery systems such as KETAPATCH™, a microneedle patch, and a wearable pump, which aim to provide easier administration compared to traditional intravenous infusions [4] Regulatory Designations - The FDA has granted five orphan drug designations to PharmaTher for ketamine treatments addressing conditions like Amyotrophic Lateral Sclerosis (ALS) and Rett Syndrome [5] - These designations highlight the company's commitment to addressing critical unmet medical needs, particularly in mental health and pain management [6] Strategic Positioning - PharmaTher aims to leverage the CNPV program to enhance its development timeline and deliver value to patients and shareholders, aligning with national health priorities [7] - The company is positioned to become a leader in the pharmaceutical development of ketamine through its focus on novel, intellectual property-protected delivery systems [7]