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First - in - class selective brain mTORC1 activator Directly activates mTORC1 enhancing synaptic activity and cellular metabolism in the brain Early efficacy signal on HAMD - 6 scale in TRD patients Rapid onset of action (signal at 2 hours) Meaningful effect sizes (>0.4 through 3 days on 1 dose) Multiple ascending dose (MAD) study demonstrated: drug penetration and target engagement favorable safety/tolerability profile across broad range of doses Initiated Phase II clinical trial in TRD Significant market opportunity Major depressive disorder (MDD) affects approximately 17.3M U.S. adults 1 ~30% of MDD patients are treatment resistant 2 SPN - 820 Novel MOA for Treatment - Resistant Depression (TRD) 1 - National Institute of Mental Health, 2017 National Survey on Drug Use and health 2 - Rush AJ Et al.(2006) Acute and Longer - Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STA R*D Report.
In Study 2, GOCOVRI reduced the UDysRS total score by 20.7 points (vs 6.3 with placebo) (P < 0.0001), decreased OFF time by 0.5 hours (vs an increase of 0.6 hou rs with placebo) GOCOVRI achieved reductions in dyskinesia & OFF episodes without having to adjust levodopa dose Placebo - adjusted, pooled results from pivotal trials* 27% DECREASE IN DYSKINESIA 10.1 - point reduction in UDysRS score ( - 17.7 GOCOVRI vs. - 7.6 placebo) ( 1 )( 2 ) Primary endpoint 36% DECREASE IN OFF TIME 1 - hour decrease ( - 0.6 GOCOVRI vs. 0.4 placebo) (1)(2) 29% INCREASE IN GOOD ON TIME 2.4 - hour increase (3.8 GOCOVRI vs.1.4 placebo) (1)(2) Secondary endpoints C 2022 Supernus Pharmaceuticals, Inc.
Study 1, a 24 - week study, was conducted in 121 PD patients with dyskinesia (GOCOVRI [n = 63], placebo [n = 58]). Study 2, a 12 - week study, wa s conducted in 75 PD patients with dyskinesia (GOCOVRI [n = 37], placebo [n = 38]). In Study 1, GOCOVRI reduced the UDysRS total score by 15.9 points (vs 8.0 with placebo) (P = 0.0009), decreased OFF time by 0. 6 hours (vs an increase of 0.3 hours with placebo) (P = 0.0171), and increased GOOD ON time by 3.6 hours (vs 0.8 hours with placebo) (P < 0.0001) from baseline.
Q28. Thinking about the patients you have put on Qelbree, what medications were they on/what issues were they having that le d y ou to try Qelbree ? B G F C 19% 22% 24% 27% 35% 40% 44% 50% 57% 60% 65% Patient needed something once a day New patients/patients who have not previously been on medication Qelbree offers the chance to take fewer medications rather than two or more medications to address their Concern with abuse or diversion by the patients or caretakers For patients with complex ADHD (ADHD and common overlapping associated features) Patient who needs coverage later in the day after stimulant wears off Patient on a stimulant and experiencing issues with efficacy I want to try a non - stimulant and Strattera doesn't work Parents are resistant to stimulants - parents don't want to give their kids Adderall, Ritalin, etc.
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