PharmaTher ‘applauds’ FDA’s new CNPV program

PharmaTher (PHRRF) announced its strong support for the U.S. Food and Drug Administration’s new Commissioner’s National Priority Voucher 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 portion of the application and the draft labeling at least 60 days before submitting the final application. “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. “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.”