Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
Supernus Pharmaceuticals (Nasdaq: SUPN) has resubmitted its New Drug Application (NDA) for SPN-830, an apomorphine infusion device designed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease. This resubmission addresses the FDA's questions from a Complete Response Letter (CRL) issued in April 2024. The CRL indicated that two areas required additional review or information, but no clinical safety or efficacy issues were identified as approval requirements. Supernus believes it has addressed the FDA's concerns and will continue to work closely with the agency during the review process. The company's CEO, Jack Khattar, expressed commitment to bringing SPN-830 to market, viewing it as a potentially important treatment option for Parkinson's disease patients and their families.
Supernus Pharmaceuticals (Nasdaq: SUPN) ha ripresentato la sua Domanda di Nuovo Farmaco (NDA) per SPN-830, un dispositivo per infusione di apomorfina progettato per il trattamento continuo delle fluttuazioni motorie (episodi OFF) nella malattia di Parkinson. Questa ripresentazione risponde alle domande della FDA contenute in una Lettera di Risposta Completa (CRL) emessa nell'aprile 2024. La CRL ha indicato che due aree richiedevano una revisione o informazioni aggiuntive, ma non sono stati identificati problemi clinici di sicurezza o efficacia come requisiti per l'approvazione. Supernus è convinta di aver affrontato le preoccupazioni della FDA e continuerà a collaborare strettamente con l'agenzia durante il processo di revisione. Il CEO dell'azienda, Jack Khattar, ha espresso il suo impegno a portare SPN-830 sul mercato, considerandolo un'opzione di trattamento potenzialmente importante per i pazienti affetti da Parkinson e le loro famiglie.
Supernus Pharmaceuticals (Nasdaq: SUPN) ha vuelto a presentar su Solicitud de Nuevo Medicamento (NDA) para SPN-830, un dispositivo de infusión de apomorfina diseñado para el tratamiento continuo de las fluctuaciones motoras (episodios OFF) en la enfermedad de Parkinson. Esta reapresentación aborda las preguntas de la FDA en una Carta de Respuesta Completa (CRL) emitida en abril de 2024. La CRL indicó que dos áreas requerían revisión adicional o información, pero no se identificaron problemas clínicos de seguridad o eficacia como requisitos para la aprobación. Supernus cree que ha abordado las preocupaciones de la FDA y continuará trabajando en estrecha colaboración con la agencia durante el proceso de revisión. El CEO de la empresa, Jack Khattar, expresó su compromiso de llevar SPN-830 al mercado, viéndolo como una opción de tratamiento potencialmente importante para los pacientes de Parkinson y sus familias.
슈퍼너스 제약(Supernus Pharmaceuticals, Nasdaq: SUPN)이 SPN-830에 대한 신약 신청서(NDA)를 재제출했습니다. SPN-830은 파킨슨병에서의 운동 변동(OFF 에피소드) 치료를 위한 아포모르핀 주입 장치입니다. 이번 재제출은 2024년 4월에 발행된 FDA의 완전 응답 편지(CRL)에서 제기된 질문에 답하기 위한 것입니다. CRL은 두 가지 분야가 추가 검토 또는 정보가 필요하다고 밝혔지만, 승인 요건으로서 임상 안전성 또는 효능 문제는 식별되지 않았습니다. 슈퍼너스는 FDA의 우려를 해결했다고 믿으며, 검토 과정에서 기관과 긴밀히 협력할 것이라고 밝혔습니다. 회사의 CEO인 잭 카타르(Jack Khattar)는 SPN-830을 시장에 출시하겠다는 의지를 표현하며, 이를 파킨슨병 환자와 그 가족들에게 잠재적으로 중요한 치료 옵션으로 보고 있습니다.
Supernus Pharmaceuticals (Nasdaq: SUPN) a représenté à nouveau sa Demande de Nouveau Médicament (NDA) pour SPN-830, un dispositif d'infusion d'apomorphine conçu pour le traitement continu des fluctuations motrices (épisodes OFF) dans la maladie de Parkinson. Cette nouvelle représentation répond aux questions de la FDA soulevées dans une Lettre de Réponse Complète (CRL) émise en avril 2024. La CRL a indiqué que deux domaines nécessitaient un examen ou des informations supplémentaires, mais aucun problème de sécurité ou d'efficacité clinique n'a été identifié comme exigence d'approbation. Supernus croit avoir résolu les préoccupations de la FDA et continuera à travailler en étroite collaboration avec l'agence pendant le processus d'examen. Le PDG de l'entreprise, Jack Khattar, a exprimé son engagement à mettre SPN-830 sur le marché, le considérant comme une option de traitement potentiellement importante pour les patients atteints de Parkinson et leurs familles.
Supernus Pharmaceuticals (Nasdaq: SUPN) hat seine Antrag auf ein neues Medikament (NDA) für SPN-830, ein Apomorphin-Infusionsgerät, das für die stetige Behandlung von motorischen Schwankungen (OFF-Episoden) bei Parkinson entwickelt wurde, erneut eingereicht. Diese Einreichung beantwortet die Fragen der FDA aus einem im April 2024 erteilten vollständigen Antwortschreiben (CRL). Der CRL deutete darauf hin, dass in zwei Bereichen eine zusätzliche Überprüfung oder Information erforderlich war, dass jedoch keine klinischen Sicherheits- oder Wirksamkeitsprobleme als Zulassungsvoraussetzung identifiziert wurden. Supernus glaubt, dass es die Bedenken der FDA angesprochen hat und weiterhin eng mit der Behörde während des Prüfprozesses zusammenarbeiten wird. Der CEO des Unternehmens, Jack Khattar, drückte sein Engagement aus, SPN-830 auf den Markt zu bringen, da er es als potenziell wichtige Behandlungsmöglichkeit für Patienten mit Parkinson und deren Familien ansieht.
- Resubmission of NDA for SPN-830, addressing FDA's previous concerns
- No clinical safety or efficacy issues identified in the previous CRL
- Potential new treatment option for Parkinson's disease patients if approved
- Delay in potential approval due to previous Complete Response Letter
- Uncertainty regarding FDA's acceptance of the resubmitted NDA
The resubmission of Supernus Pharmaceuticals' New Drug Application (NDA) for SPN-830 is a significant development in the Parkinson's disease (PD) treatment landscape. This apomorphine infusion device aims to address a critical unmet need in managing motor fluctuations, particularly OFF episodes, which significantly impact patients' quality of life.
Key points to consider:
- Addressing FDA concerns: Supernus believes it has adequately responded to the FDA's questions from the April 2024 Complete Response Letter (CRL). This suggests the company has likely provided additional data or clarifications, potentially strengthening the application.
- No clinical safety or efficacy issues: The FDA did not identify any concerns regarding the drug's safety or efficacy in the CRL, which is a positive sign for potential approval.
- Novel delivery method: If approved, SPN-830 would offer a continuous infusion option for apomorphine, potentially providing more consistent symptom control compared to existing intermittent therapies.
The resubmission indicates Supernus' confidence in the product and its potential market value. However, investors should note that FDA approval is not guaranteed and the review process may still uncover new concerns or require additional information.
Supernus Pharmaceuticals' resubmission of the NDA for SPN-830 is a positive step for the company's pipeline and potential future revenue streams. Here's what investors should consider:
- Market opportunity: Parkinson's disease affects approximately 1 million people in the US, with a growing patient population due to an aging demographic. A novel treatment for motor fluctuations could capture a significant market share.
- Competitive landscape: If approved, SPN-830 would compete with existing PD treatments, including other apomorphine formulations. Its continuous infusion approach could differentiate it in the market.
- Financial implications: Approval and successful commercialization of SPN-830 could potentially boost Supernus' revenue and diversify its product portfolio, reducing reliance on existing CNS drugs.
- Regulatory risks: While the company believes it has addressed FDA concerns, there's still a possibility of further delays or requests for additional information, which could impact the timeline to market.
Investors should monitor the FDA's response to this resubmission, as it will be important in determining the near-term prospects for SPN-830 and its potential impact on Supernus' financial performance. The lack of clinical safety or efficacy issues in the previous CRL is encouraging, but regulatory hurdles remain a key risk factor.
ROCKVILLE, Md., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
Supernus believes it has addressed the U.S. Food and Drug Administration’s (FDA) questions related to a Complete Response Letter (CRL) issued in April 2024 for the SPN-830 NDA. The CRL had indicated that the review cycle for the application was complete, but that two areas either required additional review by the FDA or additional information to be provided to the FDA. No clinical safety or efficacy issues were identified at that time as a requirement for approval. Supernus will continue to work closely with the FDA as it reviews the SPN-830 NDA.
“We continue to show our commitment to bring SPN-830 to the market and will support the FDA throughout the NDA review process,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “If approved, we believe this novel therapy can be an important treatment option for PD patients and their families.”
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.
For more information, please visit www.supernus.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s ability to conduct and progress product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-830; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.
CONTACT:
Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591
Or
INVESTOR CONTACT:
Peter Vozzo
ICR Westwicke
(443) 213-0505
peter.vozzo@westwicke.com
FAQ
What is the current status of Supernus Pharmaceuticals' SPN-830 NDA?
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