Developer · SUPN · United States
Supernus Pharmaceuticals, Inc.
CNS-focused pharmaceutical company headquartered in Rockville, Maryland (Nasdaq: SUPN). Markets Qelbree (viloxazine ER, SPN-812) for ADHD, Trokendi XR and Oxtellar XR for epilepsy/migraine, and GOCOVRI for Parkinson's disease dyskinesia. Developed SPN-810 (extended-release molindone) for impulsive aggression in ADHD through two Phase 3 misses before halting the program in February 2020.
Pipeline (1)
- Attention-deficit/hyperactivity disorderDiscontinuedDiscontinued
Catalysts · 0 upcoming · 2 reported
Recently reported
- 2020-02-25missed
SPN-810 (molindone ER)forAttention-deficit/hyperactivity disorderTopline data
Phase 3 P302 (CHIME 2) of SPN-810 36 mg in impulsive aggression in children 6-11 with ADHD missed its primary endpoint (median 51.3% reduction in weekly IA episode frequency, p=0.961 vs placebo); Supernus halted all SPN-810 development in impulsive aggression.
- 2019-11-05missed
SPN-810 (molindone ER)forAttention-deficit/hyperactivity disorderTopline data
Phase 3 P301 (CHIME 1) of SPN-810 36 mg in impulsive aggression in children 6-11 with ADHD missed its primary endpoint: median 58.6% reduction in weekly IA episode frequency, p=0.092 vs placebo on the combined stage 1+2 analysis.
Recent activity
- Feb 25, 2020ReadoutSPN-810 (molindone ER)·Attention-deficit/hyperactivity disordermissedPhase 3 P302 (CHIME 2) of SPN-810 36 mg in impulsive aggression in children 6-11 with ADHD missed its primary endpoint (median 51.3% reduction in weekly IA episode frequency, p=0.961 vs placebo); Supernus halted all SPN-810 development in impulsive aggression.source ↗
- Nov 5, 2019ReadoutSPN-810 (molindone ER)·Attention-deficit/hyperactivity disordermissedPhase 3 P301 (CHIME 1) of SPN-810 36 mg in impulsive aggression in children 6-11 with ADHD missed its primary endpoint: median 58.6% reduction in weekly IA episode frequency, p=0.092 vs placebo on the combined stage 1+2 analysis.source ↗
- Jan 25, 2016Phase changeSPN-810 (molindone ER)·Attention-deficit/hyperactivity disorderPhase 3Phase 3 CHIME program opened with 810P301 (NCT02618408, started 2016-01-25), followed by 810P302 (NCT02618434, 2016-02-16) and the 810P304 open-label extension (NCT02691182, April 2016). The advance to late-stage development had been announced 2012-11-20 on positive Phase 2b results, and FDA granted Fast Track designation 2014-08-14.source ↗
- Oct 21, 2008Phase changeSPN-810 (molindone ER)·Attention-deficit/hyperactivity disorderPhase 2Phase 2a study 810P201 (NCT00626236) started: safety and tolerability of SPN-810 in 78 children with ADHD and persistent serious conduct problems.source ↗
Competitive landscape
Other companies developing against Supernus Pharmaceuticals, Inc.'s targets or indications.
- Otsuka Pharmaceutical Co., Ltd.2 compoundsD2Attention-deficit/hyperactivity disorder
- Alkermes plc1 compoundD2
- Axsome Therapeutics, Inc.1 compoundAttention-deficit/hyperactivity disorder
- Definium Therapeutics, Inc.1 compoundAttention-deficit/hyperactivity disorder
- Engrail Therapeutics, Inc.1 compoundD2
- LB Pharmaceuticals Inc.1 compoundD2
- Reviva Pharmaceuticals Holdings, Inc.1 compoundD2
- Teva Pharmaceutical Industries Ltd.1 compoundD2