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Thursday, December 31, 2020

Supernus avoids the worst

 The good news for Supernus is that its non-stimulant ADHD contender SPN-812 now has a shot at the adult population, after its pivotal P306 study showed a statistically significant effect versus placebo. Detailed analysis is still pending, but flexible SPN-812 dosing, starting at 200mg once daily and including titration up to 600mg, has yielded a 15.5-point overall reduction from baseline in week-six AISRS score, which was 3.8 points better than for placebo (p=0.004). The baseline values have not yet been disclosed. The group therefore appears to have avoided a dose-plateau effect, which scuppered the final of four pivotal SPN-812 trials in children and adolescents. That study, P304, had focused primarily on 600mg. A bigger issue is how SPN-812 might fare against Lilly’s similarly acting Strattera, especially now that this drug is available generically; it is vital for Supernus to show that SPN-812 has a better safety profile than Strattera. And Supernus’s path to market in children and adolescents is not clear cut: the SPN-812 filing was last month hit with a complete response letter, which the company says it will discuss with the FDA in January.

Supernus's phase III plan for SPN-812
StudySettingPlacebo100mg200mg400mg600mg
  Change in ADHD rating scale-5 (7wk)
P301Low dose in children-10.9-16.6-17.7  
P302Low dose in adolescents-11.4 -16-16.5 
P303High dose in children-11.7 -17.6-17.5 
P304High dose in adolescents-13.2  -18.3*-16.7**
  Change in AISRS (6wk)
P306200-600mg titration in adults-11.7NA-15.5
  Study detail
P308200mg in children (classroom study)Trial withdrawn (corporate decision)
P310Long-term safety in paediatrics ("optimised" dose)Primary measure is AE incidence
P311Long-term safety in adults (200-600mg)Primary measure is AE incidence
Note: *nominally positive, but statistically not significant; **did not meet statistical significance vs placebo; all other reported trials met significance vs placebo. Source: clinicaltrials.gov & company press releases.

https://www.evaluate.com/vantage/articles/news/snippets/supernus-avoids-worst

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