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
- FDA approval goal date set for August 9, 2025 for ketamine product
- Company holds five FDA orphan drug designations for various conditions
- New CNPV program could reduce FDA review time from 10-12 months to 1-2 months
- Development of innovative delivery systems (KETAPATCH™ and wearable pump) offering alternatives to IV infusions
- Strong alignment with national health priorities could accelerate development timeline
- CMC portion and draft labeling must be submitted 60 days before final application
- Success in obtaining CNPV status not guaranteed
- Products still in development phase with pending approvals
Provides Accelerated Path to Market for PharmaTher’s Ketamine-based Proprietary Delivery Systems & Orphan Drug Designations, and Leveraging its Ketamine Product, having an FDA Approval Goal Date on August 9, 2025
TORONTO, June 18, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a company focused on unlocking the pharmaceutical potential of ketamine, today announced its strong support for the U.S. Food and Drug Administration's (FDA) new Commissioner’s National Priority Voucher (CNPV) program. This initiative awards vouchers to companies developing products that align with U.S. national health interests. PharmaTher believes its proprietary ketamine programs are highly congruent with the goals of this program and intends to pursue this pathway to expedite the development and regulatory review of its novel ketamine therapies.
The new CNPV program will allow drug developers to participate in a novel FDA priority program that significantly shortens the review time for a final drug application from approximately 10-12 months to 1-2 months. In addition to accelerated review, the agency may also grant accelerated approval if the product meets the applicable legal requirements. The new review program also includes enhanced communication with the sponsor throughout the process. To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application.
FDA Approval Goal Date on August 9, 2025: PharmaTher possesses a robust CMC package for its ketamine product, which has an FDA approval goal date of August 9th, 2025.
Promising Clinical Data: The Company also has promising clinical data supporting its use in rare and near-rare disorders such as Parkinson’s disease and Complex Regional Pain Syndrome. PharmaTher is developing KETAPATCH™, a ketamine microneedle patch, and a ketamine on-body wearable pump. These innovations offer a potential alternative to cumbersome intravenous infusions, providing ease of administration for at-home, hospital, and emergency care settings, where rapid, reliable treatment is critical for surgery, pain management, mental health, neurological disorders, and medical countermeasures.
Granted FDA Orphan Drug Designations: Furthermore, the FDA has granted five orphan drug designations to PharmaTher for ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS), Rett Syndrome, Complex Regional Pain Syndrome (CRPS), Status Epilepticus (prolonged seizures), and the prevention of ischemia/reperfusion injury during solid organ transplantation.
PharmaTher is advancing a pipeline of ketamine-based treatments designed to address critical unmet medical needs that align with U.S. national priorities. These include addressing the ongoing mental health crisis and the urgent need for non-opioid pain solutions for both civilian and military populations.
"The FDA's new Commissioner’s National Priority Voucher program is a visionary initiative that acknowledges the urgent need for innovation in areas vital to the nation’s well-being. This aligns perfectly with our mission to unlock the full therapeutic potential of ketamine for severe mental health, neurological, and pain disorders," said Fabio Chianelli, CEO of PharmaTher. "Our ketamine platforms, featuring proprietary KETAPATCH™ and a ketamine on-body wearable pump delivery systems, is designed to be a safe, non-invasive, and easily administered solution. This makes it an ideal candidate for situations requiring rapid, reliable treatment, from a doctor's office to potential emergency and battlefield settings. We believe this new FDA pathway provides a clear opportunity to significantly accelerate our development timeline and deliver substantial value to both patients and shareholders, demonstrating a clear alignment with national interests."
Mr. Chianelli continued, "PharmaTher is uniquely positioned to become a leader in the pharmaceutical development of ketamine through its focus on novel, IP-protected delivery systems and formulations. The ability to secure a CNPV would be a transformative catalyst for PharmaTher. It not only validates the national importance of our work but also provides a strategic tool to hasten the availability of our therapies and represents a valuable asset that can strengthen our leadership position for ketamine. We look forward to engaging proactively with the FDA to explore the application of this program for our ketamine pipeline."
For further information about PharmaTher's ketamine-based programs and the new CNPV program, please visit PharmaTher.com and the FDA new release link, respectively.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
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FAQ
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