Company: SUPN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0001356576-25-000017
Chunk: 316

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 316
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 for Qelbree were 767,791 for full year 2024, an increase of 25% compared to full year 2023.

•The Company received a two-plus year patent term extension from the US Patent and Trademark Office for US Patent number 9,662,338 that covers Qelbree. This extends the original expiration date of the patent to the year 2035.

Product Pipeline Update

ONAPGO (formerly SPN-830) (apomorphine infusion device) for treatment of Parkinson's disease (PD)

•The Company announced in early February 2025 that the FDA approved ONAPGO (apomorphine hydrochloride), formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD. ONAPGO will be launched in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support.

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

•In November 2024, the Company reported topline results from an open label Phase 2a study in patients with treatment-resistant seizures. The study suggested a differentiated profile, with strong efficacy in focal seizures at the 3mg to 4mg twice daily doses. SPN-817 was safe and had acceptable tolerability with two subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period. 

•The Company has initiated a Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.

SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression 

•In February 2025, the Company reported topline results from a randomized double-blind placebo-controlled Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD). The study did not demonstrate a statistically significant improvement on the primary and secondary endpoints. The safety profile of SPN-820 was consistent with previous clinical trials, showing few adverse events. The Company will continue to analyze the data and decide on the future of the program. 

SPN-443 – Novel stimulant for ADHD/CNS

•The Company completed a Phase 1 pharmacokinetic study of two oral formulations in healthy adults. Both formulations of SP