Xspray Pharma AB is set to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024, after a productive meeting with the U.S. Food and Drug Administration (FDA). This decision follows a Complete Response Letter (CRL) issued by the FDA in July 2024. The resubmission incorporates FDA feedback, potentially leading to Dasynoc's launch as early as Q1 2025, assuming a two-month review period.
Addressing FDA Concerns and Enhancing Patient Safety
The FDA has recommended minor adjustments to Dasynoc's tablet strengths to reduce the risk of medication errors. While these changes are within normal variability, the FDA has requested the production of new batches before resubmission. Xspray Pharma has already initiated the production of these batches and will provide further clarification on the manufacturing process to ensure full alignment with the FDA’s requirements.
Dasynoc's Unique pH-Independent Formulation
Dasynoc is designed with a pH-independent formulation to address the challenges faced by cancer patients who rely on pH-altering medications like antacids. These medications can cause inconsistent absorption of existing cancer treatments. Dasynoc aims to minimize the risks associated with fluctuating drug absorption, ensuring patients receive consistent treatment.
Per Andersson, CEO of Xspray Pharma, stated, “We are very encouraged by the positive and collaborative discussions with the FDA. The new tablet strengths will enhance patient safety by reducing the potential for dosing errors, and we are working diligently to meet all the necessary requirements...Xspray Pharma is particularly eager to bring Dasynoc to market because of the critical need we have identified in our research. Many patients, especially those relying on pH-altering medications like antacids, face challenges with existing cancer treatments due to inconsistent absorption. Dasynoc’s innovative pH-independent formulation directly addresses this issue.”
Anticipated Regulatory Timeline
Upon resubmission, Xspray Pharma anticipates the FDA will assign a new Prescription Drug User Fee Act (PDUFA) date. A final decision is expected within two to six months of the resubmission, contingent on the review timeline set by the FDA.
About Xspray Pharma
Xspray Pharma AB (publ) is focused on developing improved PKIs for cancer treatment, utilizing its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies.
