Lundbeck and their marketing partner Otsuka (the manufacturer of the #1 selling drug Abilify) are major players in the central nervous system (CNS) space. An update on new phase 3 trial data for depression and schizophrenia are listed below. The links are below.
12-10-2014
Lundbeck 2014 Press Releases
Trial: (NCT01360645) Phase 3
Brexpiprazole as adjunct for Major Depressive Disorder (MDD)
Study 1 (2mg + ADT (N=175): -3.21, p=0.0002) MADRS
12-11-2014
Lundbeck 2014 Press Releases
Trial: (NCT01396421) Phase 3
Brexpiprazole as mono-therapy for adults with Acute Schizophrenia.
Total Score (4mg: -19.65, p=0.0006) PANSS
Both studies achieved significant efficacy results, which may lead to approval from the FDA mid 2015. Brexpiprazole has patent exclusivity through 2026.
12-10-2014
Lundbeck 2014 Press Releases
Trial: (NCT01360645) Phase 3
Brexpiprazole as adjunct for Major Depressive Disorder (MDD)
Study 1 (2mg + ADT (N=175): -3.21, p=0.0002) MADRS
12-11-2014
Lundbeck 2014 Press Releases
Trial: (NCT01396421) Phase 3
Brexpiprazole as mono-therapy for adults with Acute Schizophrenia.
Total Score (4mg: -19.65, p=0.0006) PANSS
Both studies achieved significant efficacy results, which may lead to approval from the FDA mid 2015. Brexpiprazole has patent exclusivity through 2026.
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