Xspray Pharma Announces Positive FDA Meeting, Plans Dasynoc NDA Resubmission

Xspray Pharma AB, a pharmaceutical company listed on Nasdaq Stockholm, has announced considerable advancements following a fruitful discussion with the U.S. Food and Drug Administration (FDA). The company is preparing to resubmit its New Drug Application (NDA) for Dasynoc in the last quarter of 2024. This move incorporates the feedback from the FDA’s Complete Response Letter received in July 2024. If the FDA assigns a two-month review period upon resubmission, Dasynoc could potentially be launched as early as the first quarter of 2025.

The FDA has suggested modifications to the tablet strengths of Dasynoc to minimize the risk of medication errors. Although the required changes are minor, the FDA has asked for new production batches to be created before the resubmission. Xspray Pharma has already started the production of these new batches. Additionally, the company plans to provide detailed explanations regarding their manufacturing process to ensure complete compliance with FDA standards.

Per Andersson, the CEO of Xspray Pharma, expressed optimism about the positive and cooperative dialogue with the FDA. He mentioned that the new tablet strengths are designed to enhance patient safety by reducing the likelihood of dosing mistakes. Andersson stated that the production process is progressing well and that they are on schedule to resubmit the NDA in the fourth quarter of 2024.

Andersson also highlighted the urgency of bringing Dasynoc to market, pointing out the significant need identified in their research. He explained that many patients, particularly those using pH-altering medications like antacids, encounter difficulties with current cancer treatments due to inconsistent drug absorption. Dasynoc’s unique pH-independent formulation addresses this issue directly, ensuring that patients receive consistent and reliable treatments. Andersson believes that this innovation will be well-received by both healthcare providers and patients who are in need of more dependable treatment options.

Once the NDA is resubmitted, Xspray Pharma anticipates that the FDA will set a new Prescription Drug User Fee Act (PDUFA) date. A final decision from the FDA is expected within two to six months of the resubmission, depending on the review timeline established.

Xspray Pharma AB is dedicated to the development of improved protein kinase inhibitors (PKIs) for cancer treatment. The company leverages its proprietary HyNap™ technology platform to enhance the efficacy, safety, and patient experience of existing cancer therapies. The goal is to improve clinical outcomes for cancer patients. Xspray Pharma’s shares are traded on Nasdaq Stockholm.