Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

Supernus Pharmaceuticals, a leading biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) diseases, has announced the resubmission of its New Drug Application (NDA) for its apomorphine infusion device, SPN-830. This device is designed to provide continuous treatment for motor fluctuations, also known as OFF episodes, in patients with Parkinson’s disease (PD).

Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has effectively addressed the FDA’s concerns that were outlined in a Complete Response Letter (CRL) issued in October 2022. The CRL requested additional information and analysis related to the infusion device and drug product across various areas of the NDA. Importantly, the FDA did not require additional efficacy and safety clinical studies.

Supernus Pharmaceuticals has been proactive in its collaboration with the FDA, ensuring that all necessary information and analysis have been provided to support the approval of SPN-830. The company remains committed to working closely with the FDA throughout the NDA review process to bring this promising alternative treatment option to patients and their families.

Jack Khattar, the President and CEO of Supernus Pharmaceuticals, expressed enthusiasm for the potential of SPN-830, stating, “SPN-830 represents a novel and less invasive therapy approach for PD patients who are seeking a convenient option in the form of a continuous subcutaneous infusion of apomorphine.” This therapy approach could provide PD patients with a more convenient and effective treatment option, ultimately improving their quality of life.

Supernus Pharmaceuticals is renowned for its dedication to developing and commercializing products that address the unmet needs of patients with CNS diseases. The company’s diverse neuroscience portfolio already includes approved treatments for epilepsy, migraine, ADHD, hypomobility in PD, cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients.

In addition to SPN-830, Supernus Pharmaceuticals is actively developing a broad range of novel CNS product candidates, including potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. This commitment to innovation and research underscores the company’s mission to improve the lives of patients suffering from CNS diseases.

Supernus Pharmaceuticals is poised to make a significant impact in the field of CNS therapeutics. With its robust pipeline of potential treatments and its dedication to collaboration with regulatory authorities, the company is well-positioned to bring innovative and effective therapies to patients in need.

For more information about Supernus Pharmaceuticals and its groundbreaking CNS treatments, please visit their official website at www.supernus.com.