Company: SUPN
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001356576-25-000033
Chunk: 99

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 8
Chunk 99
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 serotonin, also known as a triple reuptake inhibitor. Both formulations of SPN-443 showed adequate bioavailability and were well tolerated.

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Commercial Highlights

•Total IQVIA prescriptions for Qelbree were 214,908 for the first quarter 2025, an increase of 22% compared to the same period in the prior year. For March 2025, total monthly prescriptions reached an all-time high of 75,277. Qelbree continues to expand its base of prescribers, with approximately 34,416 prescribers in the first quarter of 2025, up from 27,902 prescribers in the same period last year. 

•In April 2025, the Company launched ONAPGO, the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Initial physician response is encouraging based on very early activity in the launch. 

Product Pipeline Update

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

•The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing 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 

•The Company plans to initiate a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms.  

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 SPN-443 showed adequate bioavailability and were well tolerated. The Company expects to disclose a lead indication for the product candidate by the end of 2025.

Critical Accounting Policies and the Use of Estimates

A summary of our significant accounting policies is included in Note 2, Summary of Significant Accounting Policies of our audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2024. There were no significant changes to the disclosures with respect to