Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission
Xspray Pharma (Nasdaq Stockholm: XSPRAY) has announced plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024 following a positive FDA meeting. The company is addressing feedback from the Complete Response Letter (CRL) issued in July 2024. Key points include:
1. Potential launch of Dasynoc as early as Q1 2025 if FDA sets a two-month review period.
2. FDA recommends minor adjustments to tablet strengths to reduce medication error risks.
3. New batches with adjusted strengths are already in production.
4. Xspray will provide further clarification on the manufacturing process.
5. Dasynoc's pH-independent formulation addresses challenges faced by patients using pH-altering medications.
Xspray Pharma (Nasdaq Stockholm: XSPRAY) ha annunciato piani per ripresentare la sua domanda di autorizzazione di nuovo farmaco (NDA) per Dasynoc nel quarto trimestre del 2024, dopo un incontro positivo con la FDA. L'azienda sta affrontando il feedback ricevuto dalla Lettera di Risposta Completa (CRL) emessa a luglio 2024. I punti chiave includono:
1. Lancio potenziale di Dasynoc già dal primo trimestre del 2025, se la FDA stabilisce un periodo di revisione di due mesi.
2. La FDA raccomanda lievi aggiustamenti alle dosi delle compresse per ridurre i rischi di errore di medicazione.
3. Nuovi lotti con dosi modificate sono già in produzione.
4. Xspray fornirà ulteriori chiarimenti sul processo di produzione.
5. La formulazione indipendente dal pH di Dasynoc affronta le sfide incontrate dai pazienti che utilizzano farmaci che alterano il pH.
Xspray Pharma (Nasdaq Estocolmo: XSPRAY) ha anunciado planes para volver a presentar su Solicitud de Nuevo Medicamento (NDA) para Dasynoc en el cuarto trimestre de 2024, tras una reunión positiva con la FDA. La empresa está atendiendo las solicitudes del Carta de Respuesta Completa (CRL) emitida en julio de 2024. Los puntos clave incluyen:
1. Lanzamiento potencial de Dasynoc tan pronto como en el primer trimestre de 2025, si la FDA establece un período de revisión de dos meses.
2. La FDA recomienda ajustes menores a las concentraciones de las tabletas para reducir los riesgos de errores de medicación.
3. Nuevos lotes con concentraciones ajustadas ya están en producción.
4. Xspray proporcionará aclaraciones adicionales sobre el proceso de fabricación.
5. La formulación independiente del pH de Dasynoc aborda los desafíos que enfrentan los pacientes que usan medicamentos que alteran el pH.
Xspray Pharma (나스닥 스톡홀름: XSPRAY)는 FDA와의 긍정적인 회의 후 Dasynoc의 새로운 의약품 신청서(NDA)를 2024년 4분기에 재제출할 계획을 발표했습니다. 이 회사는 2024년 7월에 발행된 완전 응답 서한(CRL)에서 받은 피드백을 처리하고 있습니다. 주요 내용은 다음과 같습니다:
1. FDA가 2개월의 검토 기간을 설정할 경우 2025년 1분기 초에 Dasynoc을 출시할 수 있습니다.
2. FDA는 의약품 오류 위험을 줄이기 위해 정제 강도의 소규모 조정을 권장합니다.
3. 조정된 강도의 새로운 배atches이 이미 생산되고 있습니다.
4. Xspray는 제조 과정에 대한 추가 설명을 제공할 것입니다.
5. Dasynoc의 pH 비의존성 제형은 pH를 변화시키는 약물을 사용하는 환자들이 직면한 문제를 해결합니다.
Xspray Pharma (Nasdaq Stockholm : XSPRAY) a annoncé son intention de soumettre à nouveau sa demande de nouveau médicament (NDA) pour Dasynoc au quatrième trimestre 2024 à la suite d'une réunion positive avec la FDA. L'entreprise prend en compte les retours de la Lettre de Réponse Complète (CRL) émise en juillet 2024. Les points clés incluent :
1. Lancement potentiel de Dasynoc dès le premier trimestre 2025 si la FDA fixe une période de révision de deux mois.
2. La FDA recommande des ajustements mineurs aux dosages des comprimés afin de réduire les risques d'erreurs de médication.
3. De nouveaux lots avec des puissances ajustées sont déjà en production.
4. Xspray fournira des clarifications supplémentaires sur le processus de fabrication.
5. La formulation indépendante du pH de Dasynoc répond aux défis auxquels sont confrontés les patients utilisant des médicaments modifiant le pH.
Xspray Pharma (Nasdaq Stockholm: XSPRAY) hat Pläne angekündigt, seinen Antrag auf Zulassung eines neuen Arzneimittels (NDA) für Dasynoc im 4. Quartal 2024 erneut einzureichen, nachdem ein positives Treffen mit der FDA stattgefunden hat. Das Unternehmen geht auf das Feedback aus dem im Juli 2024 ausgestellten Vollständigen Antwortschreiben (CRL) ein. Die wichtigsten Punkte sind:
1. Möglicher Markteintritt von Dasynoc bereits im 1. Quartal 2025, wenn die FDA eine zweimonatige Überprüfungsfrist festlegt.
2. Die FDA empfiehlt geringfügige Anpassungen der Tablettenstärken zur Verringerung des Risikos von Medikationsfehlern.
3. Neue Chargen mit angepassten Stärken sind bereits in Produktion.
4. Xspray wird weitere Klarstellungen zum Herstellungsprozess bereitstellen.
5. Die pH-unabhängige Formulierung von Dasynoc adressiert Herausforderungen, denen Patienten gegenüberstehen, die pH-verändernde Medikamente einnehmen.
- Planned NDA resubmission for Dasynoc in Q4 2024
- Potential launch of Dasynoc as early as Q1 2025
- Production of new batches with adjusted strengths already initiated
- Dasynoc's pH-independent formulation addresses critical patient needs
- Positive and collaborative discussions with the FDA
- Delay in Dasynoc approval due to FDA's Complete Response Letter
- Need for new batches production with adjusted tablet strengths
- Additional clarification required on manufacturing process
- Uncertainty in FDA review timeline (two or six months)
Insights
The FDA meeting outcome for Xspray Pharma's Dasynoc is a significant positive development. The clear path forward with minor adjustments to tablet strengths addresses safety concerns and strengthens the NDA. The potential Q1 2025 launch, if granted a two-month review, positions Xspray favorably in the oncology market. Dasynoc's pH-independent formulation addresses a critical unmet need, potentially capturing a substantial market share among patients on pH-altering medications. This innovative approach could differentiate Xspray in the competitive cancer therapeutics landscape, potentially driving future revenue growth and market expansion.
The FDA's feedback on Xspray's Dasynoc NDA is constructive and manageable. The request for new batches with adjusted tablet strengths is a minor hurdle, easily addressed within the company's existing manufacturing capabilities. The FDA's focus on reducing medication errors demonstrates a patient-centric approach, which aligns well with current regulatory trends. The timeline for resubmission in Q4 2024 is realistic and allows for thorough preparation. The possibility of a two-month review period suggests the FDA views the resubmission favorably, potentially expediting Dasynoc's market entry. This regulatory progress significantly de-risks Xspray's path to commercialization.
Dasynoc's pH-independent formulation addresses a crucial clinical challenge in cancer treatment. Many patients require concurrent use of antacids or other pH-altering medications, which can significantly impact the efficacy of standard cancer therapies due to inconsistent absorption. By eliminating this variable, Dasynoc could improve treatment outcomes and patient quality of life. This innovation may lead to more predictable dosing, potentially reducing side effects and improving overall treatment efficacy. The medical community is likely to welcome this advancement, as it could simplify treatment protocols and enhance patient care in oncology practices.
The FDA recommends adjustments to Dasynoc's tablet strengths to reduce the risk of medication errors. Although these changes are minor (within normal variability), the FDA has requested new batches to be produced before submission. Xspray Pharma has already initiated production of these batches. The company will also provide further clarification on the manufacturing process to ensure full alignment with the FDA’s requirements.
Per Andersson, CEO of Xspray Pharma, commented: “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. Our production process is well underway, and we are on track to resubmit the NDA in Q4 2024.”
He continued: “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, which minimizes the risks associated with fluctuating drug absorption ensuring that patients can receive consistent treatments. We believe this solution will be welcomed by healthcare providers and patients alike, who are in need of more reliable treatment options.”
Upon resubmission, Xspray Pharma expects the FDA to assign a new Prescription Drug User Fee Act (PDUFA) date, with a final decision anticipated within two or six months of the resubmission, depending on the review timeline set by the FDA.
About Xspray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging 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. Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240919363821/en/
Edward
Chief Commercial Officer
Xspray Pharma AB
E-mail: edward.jordan@xspray.com
Kerstin Hasselgren
Senior Advisor & Investor Relations
Xspray Pharma AB
Mob: +46 (0) 70 311 16 83
E-mail: kerstin.hasselgren@xspray.com
Source: Xspray Pharma AB
FAQ
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