Supernus' depression drug demonstrates quick onset in mid-stage trial

Supernus Pharmaceuticals' mTORC1 activator has successfully completed a preliminary trial in patients with major depressive disorder, potentially bringing the company closer to providing a treatment that could be effective within hours.

In a Phase 2a study, Supernus' SPN-820, administered every three days in addition to baseline antidepressants, resulted in a 9.6-point reduction in the Hamilton Depression Rating Scale - 6 Items (HAM-D6) total score over 10 days. According to a Thursday release from the company, the effect was described as "rapid and substantial," with a 6.1-point reduction observed within just two hours.

Stifel analysts noted that the results moved patients from "high-to-moderate" or "low-to-severe" depression at baseline to "normal-to-mild" depression after treatment, exceeding the meaningful clinical thresholds for the scale. The rapid effect and convenient oral dosing of the drug were highlighted as highly valuable, especially since most antidepressants require at least a week before patients notice improvement.

The open-label study included 40 adults with major depressive disorder, with 38 participants completing the 10-day treatment period. Supernus reported that SPN-820 was well-tolerated, with adverse events such as headache (20%), nausea (20%), and sleepiness (15%). However, the analysts pointed out that the trial's small sample size and open-label design limit the conclusions that can be drawn about the drug's safety.

Additionally, Supernus is conducting a Phase 2b study of the same drug, administered daily to individuals with treatment-resistant depression. The company aims to complete the enrollment of 236 participants by November, with top-line data expected in the first half of the next year. The primary endpoint for this study is the change in the Montgomery-Asberg Depression Rating Scale total score over five weeks.