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 | ||||||
|---|---|---|---|---|---|---|
| Study | Setting | Placebo | 100mg | 200mg | 400mg | 600mg |
| Change in ADHD rating scale-5 (7wk) | ||||||
| P301 | Low dose in children | -10.9 | -16.6 | -17.7 | ||
| P302 | Low dose in adolescents | -11.4 | -16 | -16.5 | ||
| P303 | High dose in children | -11.7 | -17.6 | -17.5 | ||
| P304 | High dose in adolescents | -13.2 | -18.3* | -16.7** | ||
| Change in AISRS (6wk) | ||||||
| P306 | 200-600mg titration in adults | -11.7 | NA | -15.5 | ||
| Study detail | ||||||
| P308 | 200mg in children (classroom study) | Trial withdrawn (corporate decision) | ||||
| P310 | Long-term safety in paediatrics ("optimised" dose) | Primary measure is AE incidence | ||||
| P311 | Long-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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