brexpiprazole QW (OPC-34712 once weekly) / Otsuka, Lundbeck - LARVOL DELTA

Lundbeck raises financial guidance following strong start to the year with strategic brands growth of +24% CER (Lundbeck Press Release) - "The revenue of Lundbeck’s strategic brands increased by +24% CER (+28% DKK), reaching DKK 4,801 million, representing 77% of total revenue: Rexulti: DKK 1,491 million (+28% CER; +34% DKK); Brintellix/Trintellix: DKK 1,254 million (+7% CER; +7% DKK); Vyepti: DKK 1,042 million (+62% CER; +69% DKK); Abilify LAI franchise: DKK 1,014 million (+16% CER; +18% DKK)."

Sales • Major Depressive Disorder • Migraine • Schizophrenia

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=59 | Completed | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=59 | Active, not recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Trial completion date: May 2025 ➔ Mar 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Trial completion date: Jan 2025 ➔ May 2025 | Trial primary completion date: Jan 2025 ➔ May 2025

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (clinicaltrials.gov) - P3 | N=190 | Active, not recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Treatment of psychotic depression with Brexpiprazole with early response: (ECNP 2024) - "Brexpiprazole, when used in conjunction with SSRI antidepressants, appears to be a highly effective treatment modality for psychotic depression. This combination therapy not only facilitates a quicker recovery but also significantly cuts down on the costs and procedural burdens of ECT, suggesting a viable alternative in the management of this condition. Further studies with larger sample sizes are recommended"

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy of brexpiprazole on agitation in patients with dementia due to Alzheimer’s disease exhibiting behaviors most bothersome to caregivers: post hoc pooled analysis of two randomized controlled trials (AAIC 2024) - P3 | "Agitation behaviors that are most bothersome to caregivers of patients with dementia due to Alzheimer’s disease (including excessive motor activity, verbal aggression, and physical aggression) were generally well represented in the brexpiprazole trials. In patients frequently exhibiting these bothersome behaviors, fixed-dose brexpiprazole 2 or 3 mg/day was associated with larger improvements than placebo."

Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

Efficacy of brexpiprazole on frequently occurring agitation behaviors in patients with dementia due to Alzheimer’s disease: post hoc pooled analysis of two randomized controlled trials (AAIC 2024) - P3 | "Patients with agitation associated with dementia due to Alzheimer’s disease exhibited many different frequently occurring agitation behaviors. Fixed-dose brexpiprazole 2 or 3 mg/day was associated with a numerically greater reduction in the frequency of most of these frequently occurring agitation behaviors versus placebo."

Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

Guidelines for pharmacotherapy in Alzheimer's disease - A primer on FDA-approved drugs. (PubMed, J Neurosci Rural Pract) - "BPSD mitigators include brexpiprazole, an atypical antipsychotic with a once-daily dosage suited to treat agitation in dementia patients, and suvorexant, an orexin receptor antagonist used to treat sleep disturbances. Cognitive decline mitigators include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine and glutamate inhibitors such as memantine...Aducanumab is administered once every 4 weeks and lecanemab once every 2 weeks. The decision on the choice of the drug must be made after considering the availability of drug, compliance of patient (once-daily vs. multiple doses daily), cost, specific comorbidities, and the risk-benefit ratio for the particular patient. Other non-pharmacological treatment modalities must also be adopted to have a holistic approach toward the treatment of AD."

FDA event • Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Movement Disorders • Parkinson's Disease • Sleep Disorder • Solid Tumor

A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (clinicaltrials.gov) - P3 | N=190 | Recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Trial completion date: Feb 2025 ➔ Jul 2025

Trial completion date • CNS Disorders • Psychiatry • Schizophrenia

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd.

New P1 trial • CNS Disorders • Psychiatry • Schizophrenia