Summary
- Supernus is preparing for an imminent launch of SPN-812 with a PDUFA target action date of 11/08/20.
- The company is prepared for the tough competition SPN-812 will face as it competes in a crowded field for ADHD therapies.
- Supernus recently submitted its NDA for its Apomorphine Infusion Pump, or SPN-830, with putative launch in H2, 2021.
An issue dogging Supernus (SUPN) is potential generic competition for Trokendi XR in 2023 (p. 28). Trokendi XR has been Supernus' long-term revenue driver since 2014. It made up 73% (p. 19) of the company's net product sales for the first six months of 2020. Any challenge to its earnings trajectory is of serious concern to shareholders.
Providentially, Supernus is heading towards two catalysts that could make up for potential losses; these catalysts are crucial to its mid- and long-term prospects. Shareholders concerned about this situation might draw comfort from the potential that two new products may come on-line, one later this year and a second in 2021. This article focuses on these new products and their prospects to take up the slack from Trokendi XR's anticipated challenges.
The first upcoming remediatory catalyst is SPN-812, scheduled for a PDUFA target action date of 11/8/20.
Supernus' SPN-812 in treatment of attention deficit hyperactivity disorder (ADHD) began an arduous series of clinical trials in 2010 with "A Phase I/IIa, Randomized, Double-Blind Study of the Safety and Efficacy of SPN-812 in Adults With ADHD".
The slide below, from the latest corporate slide deck, provides a summary of its salient characteristics:
SPN-812 has completed four phase 3 clinical trials dubbed P301, P302, P303 and P304 (slide 21), each testing varying doses of SPN-812 in groups of children ages 5-10 (P301 and P303) and adolescents ages 11-17 (P302 and P304). The four trials treated an aggregate of ~1400 patients.
The primary outcome measure for the four studies was change from baseline to end of study in the ADHD-RS-5 total score. ADHD-RS-5 is one of a variety of scales used for assessing ADHD. The RS-5 scale is optimized for assessing symptom severity. It comes in two versions, one for children and the other for adolescents.
ADHD manifests itself in a variety of ways; there are numerous approaches to treating it medicinally, including antidepressants, anti-anxiety drugs, antipsychotics, stimulants and non-stimulants. SPN-812 falls in the category of non-stimulants.
