This section highlights FDA-related milestones and regulatory updates for drugs developed by Supernus Pharmaceuticals (SUPN).
Over the past two years, Supernus Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Qelbree, SPN-817, SPN-820, and SPN-830. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Qelbree (viloxazine extended-release capsules) - FDA Regulatory Timeline and Events
Qelbree (viloxazine extended-release capsules) is a drug developed by Supernus Pharmaceuticals for the following indication: Attention-Deficit Hyperactivity Disorder (ADHD).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Qelbree (viloxazine extended-release capsules)
- Announced Date:
- January 27, 2025
- Indication:
- Attention-Deficit Hyperactivity Disorder (ADHD)
Announcement
Supernus Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2.
AI Summary
Supernus Pharmaceuticals has announced that the FDA has approved an updated label for Qelbree (viloxazine extended‐release capsules). This update adds new pharmacodynamic data in Section 12.2, showing that Qelbree works in several ways. Notably, the data highlights its partial agonist activity at the serotonin 5-HT2C receptor and its ability to inhibit the norepinephrine transporter. These findings help to deepen the understanding of Qelbree’s multimodal action in treating ADHD.
The updated information aims to provide healthcare providers with clearer insights into how Qelbree works, supporting informed treatment decisions for patients aged 6 years and older with ADHD. By clarifying its effects on serotonin and norepinephrine, the label update reinforces Qelbree’s role as a unique treatment option in the ADHD space.
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SPN-817 - FDA Regulatory Timeline and Events
SPN-817 is a drug developed by Supernus Pharmaceuticals for the following indication: for treatment-resistant seizures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPN-817
- Announced Date:
- May 23, 2024
- Indication:
- for treatment-resistant seizures.
Announcement
Supernus Pharmaceuticals, announced data from the planned interim analysis of the exploratory open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures.
AI Summary
Supernus Pharmaceuticals recently announced interim data from the exploratory open-label Phase 2a study of SPN-817, a novel, highly selective acetylcholinesterase inhibitor designed for treatment-resistant seizures. The interim analysis, based on 41 enrolled subjects (with 19 completing the maintenance period), showed encouraging results for focal seizures. Patients receiving 3mg to 4mg twice daily experienced a 75% median reduction in focal seizures during the maintenance period, which increased to 86% in the open-label extension. Additionally, responder analyses revealed that 81% of subjects achieved at least a 30% reduction in seizure frequency. The safety profile was acceptable, with common side effects like nausea, diarrhea, and headache matching the known profile of acetylcholinesterase inhibitors. These preliminary findings will help guide the upcoming Phase 2b study, as Supernus continues to optimize dosing and improve tolerability for patients with difficult-to-treat epilepsy.
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SPN-820 - FDA Regulatory Timeline and Events
SPN-820 is a drug developed by Supernus Pharmaceuticals for the following indication: Resistant depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPN-820
- Announced Date:
- February 18, 2025
- Indication:
- Resistant depression
Announcement
Supernus Pharmaceuticals announced that the Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD) did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score to Week 4 (SPN-820 [LS mean ± Standard Error]: -12.3 ± 0.96 vs. placebo: -11.9 ± 0.96; p = not significant).
AI Summary
Supernus Pharmaceuticals shared news about its Phase 2b study of SPN-820 for adults with treatment-resistant depression (TRD). The study did not show a statistically significant improvement on the main measure, the MADRS total score at Week 4. Specifically, patients receiving SPN-820 had a score change of –12.3 (±0.96) compared to –11.9 (±0.96) in the placebo group, and the difference was not statistically significant. Despite this, SPN-820 was well-tolerated among patients, with only a few adverse events noted, consistent with earlier trials.
Supernus expressed disappointment over the study results and mentioned that they will continue reviewing the data while discussing the future of the program with their development partner, Navitor Pharmaceuticals. The company thanked everyone involved in the trial for their support and efforts.
Read Announcement- Drug:
- SPN-820
- Announced Date:
- October 10, 2024
- Indication:
- Resistant depression
Announcement
Supernus Pharmaceuticals announced that the Company will hold a webcast and conference call on Thursday, October 17, 2024, at 4:30 p.m. ET to review data from the open-label Phase 2a study of SPN-820 for the treatment of major depressive disorder.
AI Summary
Supernus Pharmaceuticals will host a webcast and conference call on Thursday, October 17, 2024, at 4:30 p.m. ET. During this session, company management will review and discuss data from the open-label Phase 2a study of SPN-820, a potential treatment for major depressive disorder. The discussion will include prepared remarks and an overview of interim trial results, allowing participants to understand the progress of this study. A live webcast with presentation slides will be accessible via the company’s Investor Relations website, and a replay will be available for 60 days after the call. Participants can pre-register to receive a dial-in number and personalized conference code. This event is an important step in providing transparency about the ongoing research and future directions for SPN-820 in the treatment of major depressive disorder.
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SPN-830 (apomorphine infusion pump) - FDA Regulatory Timeline and Events
SPN-830 (apomorphine infusion pump) is a drug developed by Supernus Pharmaceuticals for the following indication: Continuous treatment of motor fluctuations in Parkinson's disease (PD).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPN-830 (apomorphine infusion pump)
- Announced Date:
- February 4, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- Continuous treatment of motor fluctuations in Parkinson's disease (PD)
Announcement
Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.
AI Summary
Supernus Pharmaceuticals announced that ONAPGO, a new wearable subcutaneous apomorphine infusion device, will be available in the U.S. in the second quarter of 2025. This device is designed to help adults with advanced Parkinson’s disease better manage motor fluctuations by delivering continuous treatment during the waking day without the need for invasive surgery.
At launch, Supernus will provide a comprehensive support team of experts that includes a strong nurse education program and access support. This team will assist patients and healthcare providers in effectively using ONAPGO, ensuring that users receive the guidance and resources needed for its successful integration into their treatment regimen.
Read Announcement- Drug:
- SPN-830 (apomorphine infusion pump)
- Announced Date:
- February 4, 2025
- Indication:
- Continuous treatment of motor fluctuations in Parkinson's disease (PD)
Announcement
Supernus Pharmaceuticals, announced that that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD).
AI Summary
Supernus Pharmaceuticals announced that the FDA has approved ONAPGO (apomorphine hydrochloride) injection—the first and only subcutaneous apomorphine infusion device approved in the U.S. for treating motor fluctuations in adults with advanced Parkinson’s disease. This wearable device delivers continuous treatment during the waking day, helping to reduce OFF time when patients’ symptoms reappear due to limitations of current therapies. ONAPGO bypasses the gastrointestinal tract, providing direct stimulation of dopamine receptors in the brain for improved and more predictable symptom control. The new treatment offers a non-invasive alternative to traditional oral medications and is expected to provide more consistent daily benefits for patients. Supernus plans to launch ONAPGO in the second quarter of 2025, along with a dedicated support team and nurse education program to assist patients and caregivers.
Read Announcement- Drug:
- SPN-830 (apomorphine infusion pump)
- Announced Date:
- August 19, 2024
- Estimated Event Date Range:
- February 1, 2025 - February 1, 2025
- Target Action Date:
- February 01, 2025
- Indication:
- Continuous treatment of motor fluctuations in Parkinson's disease (PD)
Announcement
Supernus Pharmaceuticals, announced that The resubmission is now considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.
AI Summary
Supernus Pharmaceuticals announced a key update regarding its new drug application for the apomorphine infusion device (SPN-830), designed for the continuous treatment of motor fluctuations in Parkinson’s disease. The FDA has acknowledged the resubmission and now considers it filed, setting a user fee goal date (PDUFA date) of February 1, 2025. This milestone marks an important step in the regulatory review process, indicating that the application is on track for further evaluation by the agency. The company aims to address motor fluctuations in Parkinson’s disease with this innovative approach, reinforcing its commitment to developing effective treatments for central nervous system disorders. This FDA action highlights Supernus’s progress in navigating the regulatory pathway, providing clarity for investors and patients alike as the company moves forward with its clinical development and commercialization plans.
Read Announcement- Drug:
- SPN-830 (apomorphine infusion pump)
- Announced Date:
- August 19, 2024
- Indication:
- Continuous treatment of motor fluctuations in Parkinson's disease (PD)
Announcement
Supernus Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the 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).
AI Summary
Supernus Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its new drug application (NDA) for the SPN-830 apomorphine infusion device. This device is designed for the continuous treatment of motor fluctuations, also referred to as OFF episodes, in patients with Parkinson’s disease.
The FDA now considers the NDA resubmission filed, with a target action date set for February 1, 2025. This milestone is an important step for Supernus as it moves closer to providing a new treatment option that may help manage the motor symptoms of Parkinson’s disease more effectively. The company’s focus remains on developing and commercializing innovative therapies for central nervous system disorders.
Read Announcement- Drug:
- SPN-830 (apomorphine infusion pump)
- Announced Date:
- April 8, 2024
- Indication:
- Continuous treatment of motor fluctuations in Parkinson's disease (PD)
Announcement
Supernus Pharmaceuticals, announced a regulatory update for SPN-830.
AI Summary
Supernus Pharmaceuticals recently received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for SPN-830. SPN-830 is an investigational apomorphine infusion device intended for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson’s disease. The FDA’s CRL indicates that while the review cycle is complete, the application is not ready for approval in its current form.
The letter highlighted two main issues. One concerns product quality, for which Supernus has already submitted additional data that the FDA has yet to review. The second issue involves the master file for the infusion device, which remains proprietary to the device manufacturer. Supernus plans to discuss with the manufacturer the steps needed to meet the FDA’s requirements and successfully resubmit the NDA, underlining the company's commitment to providing a valuable treatment option for PD patients.
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