Fanapt LAI (iloperidone depot injectable formulation) / Vanda - LARVOL DELTA

A systematic review of the real-world effectiveness and economic and humanistic outcomes of selected oral antipsychotics among patients with schizophrenia in the United States: Updating the evidence and gaps. (PubMed, J Manag Care Spec Pharm) - "To review existing evidence and gaps regarding real-world effectiveness and economic and humanistic outcomes of OATs, including asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine/samidorphan, paliperidone, and quetiapine. Our findings also suggest an unmet need regarding treatment nonadherence and lack of persistence among patients receiving OATs. We identified a need for research addressing OATs' behavioral and humanistic outcomes and evaluating the impact of product switching in adults with schizophrenia in the United States, which could assist clinicians in promoting patient-centered care and help payers understand the total value of new antipsychotic drugs."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Review • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Network Meta-Analysis of Efficacy and Safety of Atypical Antipsychotics Used for the Maintenance Treatment of Adults With Schizophrenia (ISPOR-EU 2023) - "Compared to placebo, the long-acting injectable (LAI) formulation of aripiprazole once monthly (1M) (relative risk, 95% credible intervals: 0.43, 0.19-0.82), paliperidone palmitate (PP-1M: 0.43, 0.17-0.87; PP-3M: 0.37, 0.14-0.78), olanzapine 1M (0.34, 0.1-0.92), risperidone every 2-weeks (0.25, 0.08-0.62) showed a statistically significant reduction in the risk of relapse at week 26 using RE model. Oral AAs such as olanzapine (0.17, 0.06-0.44), paliperidone extended-release (ER) (0.2, 0.08-0.45), iloperidone (0.24, 0.07-0.67), asenapine (0.3, 0.09-0.77), quetiapine (0.35, 0.15-0.69), aripiprazole (0.4, 0.19-0.74), and brexpiprazole (0.41, 0.12-0.97) also showed a statistically significantly reduced risk of relapse compared to placebo at week 26. However, other oral AAs (risperidone, lurasidone, cariprazine, and ziprasidone ER) and PP-6M LAI were associated with numerically lower but statistically non-significant relapse rates compared to placebo... The maintenance..."

Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Completed | N=24 ➔ 42

Enrollment change • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Vanda Pharmaceuticals | Trial completion date: Jan 2022 ➔ Sep 2022 | Trial primary completion date: Jan 2022 ➔ Sep 2022

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

Oral and long-acting antipsychotics for relapse prevention in schizophrenia-spectrum disorders: a network meta-analysis of 92 randomized trials including 22,645 participants. (PubMed, World Psychiatry) - "Compared to placebo, "high" confidence in the results was found for (in descending order of effect magnitude) amisulpride-oral (OS), olanzapine-OS, aripiprazole-LAI, olanzapine-LAI, aripiprazole-OS, paliperidone-OS, and ziprasidone-OS. "Moderate" confidence in the results was found for paliperidone-LAI 1-monthly, iloperidone-OS, fluphenazine-OS, brexpiprazole-OS, paliperidone-LAI 1-monthly, asenapine-OS, haloperidol-OS, quetiapine-OS, cariprazine-OS, and lurasidone-OS...This finding is of particular relevance for low- and middle-income countries and constrained-resource settings, where few medications may be selected. Results from this network meta-analysis can inform clinical guidelines and national and international drug regulation policies."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

The Effect of Chronic Iloperidone Treatment on Cytochrome P450 Expression and Activity in the Rat Liver: Involvement of Neuroendocrine Mechanisms. (PubMed, Int J Mol Sci) - "At the same time, the level of GHRH, GH, and corticosterone decreased while that of T increased, with no changes in IL-2 and IL-6. The presented results indicate neuroendocrine regulation of the investigated CYP enzymes during chronic iloperidone treatment and suggest a possibility of pharmacokinetic/metabolic interactions produced by the neuroleptic during prolonged combined treatment with drugs that are substrates of iloperidone-affected CYP enzymes."

Journal • Preclinical • CNS Disorders • Psychiatry • Schizophrenia • CYP1A2 • CYP2C19 • CYP2E1 • IL2 • IL6

Vanda Pharmaceuticals Reports Second Quarter 2021 Financial Results (PRNewswire) - "Fanapt® net product sales were $23.4 million in the second quarter of 2021, a 13% increase compared to $20.6 million in the second quarter of 2020....Fanapt® net product sales were $46.7 million in the first six months of 2021, an 8% increase compared to $43.3 million in the first six months of 2020....A clinical pharmacology study of the long acting injectable (LAI) formulation of Fanapt® is ongoing."

Sales • Trial status • CNS Disorders • Schizophrenia

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results (PRNewswire) - "Total net product sales from HETLIOZ® and Fanapt® were $67.7 million in the fourth quarter of 2020, an 11% increase compared to $60.9 million in the fourth quarter of 2019....Fanapt® net product sales were $23.5 million in the fourth quarter of 2020, a 5% increase compared to $22.3 million in the fourth quarter of 2019....Total net product sales from HETLIOZ® and Fanapt® were $248.2 million for the full year 2020, a 9% increase compared to $227.2 million for the full year 2019....Fanapt® net product sales were $87.5 million for the full year 2020, a 4% increase compared to $84.2 million for the full year 2019....Development of the long acting injectable (LAI) formulation of Fanapt® is ongoing."

Sales • CNS Disorders • Schizophrenia • Sleep Disorder

Edited Transcript of VNDA.OQ earnings conference call or presentation 10-Feb-21 9:30pm GMT (Yahoo Finance) - "On Fanapt for Parkinson's disease psychosis, we're planning 2 studies: a Phase II open-label study of 2 cohorts; followed by a larger, randomized, placebo-controlled Phase III study. Both studies will evaluate the efficacy of Fanapt in the treatment of psychosis in Parkinson's disease. 20% to 40% of people with Parkinson's disease...The Phase II cohort of 24-patient open-label study has now received approval to proceed by the FDA and is expected to commence this quarter."

New P2 trial • New P3 trial • CNS Disorders • Parkinson's Disease

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results (PRNewswire) - "Fanapt® (iloperidone)...A clinical program for Fanapt® in Parkinson's disease psychosis (PDP) is expected to begin in the first quarter of 2021."

New trial • CNS Disorders • Parkinson's Disease

Evaluating the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-Acting Injection (LAI) in Schizophrenia (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Vanda Pharmaceuticals

Clinical • New P1 trial • CNS Disorders • Psychiatry • Schizophrenia

Vanda Pharmaceuticals Reports Third Quarter 2020 Financial Results (PRNewswire) - "Fanapt® net product sales were $20.7 million in the third quarter of 2020, a 6% decrease compared to $21.9 million in the third quarter of 2019....Vanda continues to implement marketing and sales strategies aimed at supporting continued growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the Fanapt® for schizophrenia direct-to-consumer campaign, which was launched at the end of the second quarter of 2020....The COVID-19 pandemic has impacted clinical research globally, including some of Vanda's previously reported clinical trials....Fanapt® bipolar disorder and long acting injectable studies, is currently on hold."

Commercial • Sales • Trial suspension • CNS Disorders • Schizophrenia

Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia. (PubMed, Am J Psychiatry) - "The 95% effective doses and the doses equivalent to 1 mg of oral risperidone, respectively, were as follows: amisulpride for patients with positive symptoms, 537 mg/day and 85.8 mg; aripiprazole, 11.5 mg/day and 1.8 mg; aripiprazole LAI (lauroxil), 463 mg every 4 weeks and 264 mg; asenapine, 15.0 mg/day and 2.4 mg; brexpiprazole, 3.36 mg/day and 0.54 mg; haloperidol, 6.3 mg/day and 1.01 mg; iloperidone, 20.13 mg/day and 3.2 mg; lurasidone, 147 mg/day and 23.5 mg; olanzapine, 15.2 mg/day and 2.4 mg; olanzapine LAI, 277 mg every 2 weeks and 3.2 mg; paliperidone, 13.4 mg/day and 2.1 mg; paliperidone LAI, 120 mg every 4 weeks and 1.53 mg; quetiapine, 482 mg/day and 77 mg; risperidone, 6.3 mg/day and 1 mg; risperidone LAI, 36.6 mg every 2 weeks and 0.42 mg; sertindole, 22.5 mg/day and 3.6 mg; and ziprasidone, 186 mg/day and 30 mg...In chronic schizophrenia patients with acute exacerbations, doses higher than the identified 95% effective doses may on average not provide more..."

Journal • Retrospective data • CNS Disorders • Schizophrenia

Vanda Pharma up 24% after Q2 beat, Citi upgrade (SeekingAlpha) - "Fanapt sales up 10% to $21.2M....2019 guidance: Sales: $215M - 225 (unch); Hetlioz: $137M-143M; Fanapt: $78M - 82M."

Sales

Vanda Pharmaceuticals reports second quarter 2019 financial results (Yahoo Finance) - "Enrollment is ongoing in a pharmacokinetic study for the once-a-month long acting injectable (LAI) formulation of Fanapt®. A randomized study of Fanapt® in bipolar disorder is planned to begin in 2019."

Enrollment status • New trial