Lonasen tape (blonanserin transdermal patch) / Nitto Denko, Sumitomo Pharma - LARVOL DELTA

Comparison of Efficacies of a Blonanserin Transdermal Patch and Blonanserin Oral Formulation for Psychiatric Symptoms in Patients With Schizophrenia Treated With Laxatives Using a Japanese Claims Database. (PubMed, Neuropsychopharmacol Rep) - "No significant difference was observed in the risk of hospitalization for patients with schizophrenia treated with laxatives between the BNS patch and BNS oral groups. The effectiveness of antipsychotic patches in these patients warrants further research that considers factors such as patch preference in the elderly."

Clinical • Journal • Retrospective data • CNS Disorders • Gastrointestinal Disorder • Psychiatry • Schizophrenia

Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms. (PubMed, Neuropsychopharmacol Rep) - "BNS-P exhibited a dose-dependent antipsychotic effect in all clusters, particularly highlighting its efficacy in patients with predominant positive symptoms, even at lower doses. These findings provide novel and valuable insights for determining BNS-P dose tailoring to individual symptomatic characteristics in real-world practice."

Clinical • Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Investigation of the usefulness of blonanserin transdermal patch in patients with acute-phase schizophrenia (ECNP 2024) - "The lower incidence of EPS may be due to more stable plasma blonanserin levels with transdermal patches. ・ Conclusion BNS-p is minimally invasive in the treatment of patients with acute phase schizophrenia, is well tolerance by patients, and has few adverse events included EPS, suggested that it has sufficient therapeutic utility."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Novel therapies for nausea and vomiting in advanced illness and supportive cancer care. (PubMed, Palliat Care Soc Pract) - "This review discusses blonanserin, mirtazapine, and isopropyl alcohol as antiemetics...There is little evidence that mirtazapine improves anorexia or nausea in advanced cancer but is as effective as olanzapine in reducing chemotherapy-induced nausea and vomiting. Isopropyl alcohol aromatherapy has been successfully used in the emergency department for nausea and vomiting with an onset to benefit more rapidly than standard antiemetics. Isopropyl alcohol prep pads can be used for home-going antiemetic therapy and as a bridge to treating acute nausea until standard antiemetics take effect."

Journal • Metastases • Review • Anorexia • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Depression • Oncology • Pain • Psychiatry

Severe behavioral and psychological symptoms of dementia successfully treated at home with a blonanserin transdermal patch: A case report. (PubMed, Neuropsychopharmacol Rep) - "The blonanserin transdermal patch may be able to manage BPSD at home and is effective in patients who refuse oral medications. Home-visiting doctors may consider the use of blonanserin patches at home for patients with severe BPSD, manifesting as delusions of poisoning and refusing oral drugs."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Successful Management of Terminal Delirium With Transdermal Blonanserin Patch in a Terminally Ill Cancer Patient. (PubMed, J Palliat Med) - "Nonpharmacological interventions and oral risperidone plus intravenous haloperidol failed to improve his condition. However, he deteriorated a week later with an estimated survival of days, ultimately requiring continuous midazolam for refractory agitation. This case underscores the potential of transdermal blonanserin patches for delirium in terminally ill cancer patients, emphasizing the need for future prospective studies."

Journal • CNS Disorders • Cognitive Disorders • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy of Blonanserin Transdermal Patch on Terminal Delirium in Patients with Respiratory Diseases (ERS 2023) - "Blonanserin transdermal patch performed similarly to haloperidol, as previously reported, for managing terminal delirium. Our study suggests that a blonanserin transdermal patch potentially prevents terminal delirium and alleviated uncontrolled dyspnea in patients with respiratory diseases.; Palliative care; General respiratory patient care; Pulmonary function testing; Cell and molecular biology; Epidemiology; Public health; Imaging"

Clinical • CNS Disorders • Infectious Disease • Interstitial Lung Disease • Palliative care • Pneumonia • Pulmonary Disease • Respiratory Diseases

Possible Effect of Blonanserin Transdermal Patch on Antiemetic Control in Patients with Terminal Cancer with Refractory Nausea. (PubMed, J Palliat Med) - "Background: Haloperidol is widely used for antiemetic control in advanced cancer. Of 16 patients without ascites, 12.5% had not improved their nausea, which was lower than in patients with ascites (80.0%). Blonanserin transdermal patch has a possible effect on antiemetic control in cancer patients, and its efficacy might be particularly prominent in patients without ascites."

Journal • CNS Disorders • Oncology

Efficacy of blonanserin transdermal patch on terminal delirium in patients with respiratory diseases. (PubMed, Respir Investig) - "Blonanserin transdermal patch performed similarly to haloperidol, as previously reported, for managing terminal delirium. Our study suggests that a blonanserin transdermal patch potentially prevents terminal delirium and alleviates uncontrolled dyspnea in patients with respiratory diseases. Our findings encourage clinical trials to evaluate the safety and efficacy of blonanserin transdermal patches for patients with terminal illnesses."

Journal • CNS Disorders • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Acceptability of transdermal antipsychotic patches by patients who refuse oral medication and their effectiveness in preventing recurrence of delirium: a retrospective observational study. (PubMed, Int Clin Psychopharmacol) - "Instead, a transdermal patch of blonanserin, a second-generation antipsychotic drug, was tried...The present findings suggest that transdermal antipsychotic patches are more likely to be accepted by patients who refuse oral medications. Prospective studies are needed."

Journal • Observational data • Retrospective data • CNS Disorders • Mental Retardation • Psychiatry

Prediction of Corresponding Dose of Transdermal Blonanserin to Oral Dose Based on Dopamine D2 Receptor Occupancy: Unique Characteristics of Blonanserin Transdermal Patch. (PubMed, J Clin Psychopharmacol) - "Predicted D2 occupancy suggested that a 40- to 80-mg/d blonanserin transdermal patch dose corresponds to an 8- to 24-mg/d oral dose for the treatment of schizophrenia."

Journal • CNS Disorders • Psychiatry • Schizophrenia • DRD2

Early improvement as a predictor of response to blonanserin transdermal patch in patients with schizophrenia. (PubMed, Schizophr Res) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

Switching from blonanserin oral tablets/powders to transdermal patches alleviates extrapyramidal symptoms in patients with schizophrenia: A 52-week open-label study. (PubMed, Prog Neuropsychopharmacol Biol Psychiatry) - "In cohort 1 (n = 97), patients received 40-80 mg/day blonanserin transdermal patches for one year after taking 8-16 mg/day blonanserin tablets for 6 weeks, and the dose of patches was determined based on the dose of the tablets...Changes from the start of transdermal patch treatment in EPS and the dose of antiparkinsonian drugs at 3, 6, and 12 months were assessed using the Drug-Induced EPS Scale (DIEPSS) and biperiden equivalents of total antiparkinsonian drugs (BPD-eq), respectively...In contrast, there were no significant changes from the start of patch treatment in BPD-eq at any month (p > 0.05). Transdermal patches of blonanserin are a more effective route of administration to diminish EPS than oral tablets/powder."

Clinical • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Use of Blonanserin Transdermal Patch in Home Treatment of Schizophrenia: A Case Study. (PubMed, J Clin Psychopharmacol) - No abstract available

Clinical • Journal • CNS Disorders • Psychiatry • Schizophrenia

Efficacy and safety of antipsychotic treatments for schizophrenia: A systematic review and network meta-analysis of randomized trials in Japan. (PubMed, J Psychiatr Res) - "Our results are similar to those of previous network meta-analysis involving various races and ethnicities."

Journal • Retrospective data • Review • CNS Disorders • Psychiatry • Schizophrenia

[VIRTUAL] Efficacy and Safety of Blonanserin Transdermal Patch in Patients with Schizophrenia: A Multicenter Open-Label Extension Study (CINP 2021) - "BNS transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability, and no negative findings were observed even with long-term use."

Clinical • CNS Disorders • Dermatology • Insomnia • Movement Disorders • Pruritus • Psychiatry • Schizophrenia • Sleep Disorder

[VIRTUAL] Efficacy and Safety of Blonanserin Transdermal Patch in Patients with Schizophrenia: A 6-Week Randomized, DoubleBlind, Placebo Controlled, Multicenter Study (CINP 2021) - P3 | "BNS transdermal patch improved the symptoms of acute schizophrenia with acceptable Tolerability."

Clinical • CNS Disorders • Dermatology • Insomnia • Movement Disorders • Pruritus • Psychiatry • Schizophrenia • Sleep Disorder

Pharmacokinetic evaluation of blonanserin transdermal patch: Population analysis and simulation of plasma concentration and dopamine D receptor occupancy in clinical settings. (PubMed, J Clin Pharmacol) - "In the case of failure to remove the previous patch or a missing application, the increase or decrease in plasma concentration and dopamine D receptor occupancy was less than 20%. These results indicated that the plasma blonanserin concentration and dopamine D receptor occupancy were stable after blonanserin transdermal patch application, which may lead to improved tolerability during the treatment of patients with schizophrenia."

Clinical • Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Supplementary Financial Data (IFRS) for the Second Quarter of the Year Ending March 31, 2021 (Dainippon Sumitomo Press Release)

Sales • CNS Disorders • Depression • Schizophrenia

Transdermal Delivery of Antipsychotics: Rationale and Current Status. (PubMed, CNS Drugs) - "Despite the current availability of a large number of antipsychotics, only a few of these drugs (e.g. aripiprazole, asenapine, blonanserin, chlorpromazine, haloperidol, olanzapine, prochlorperazine, quetiapine, and risperidone) have been developed as transdermal delivery systems...However, few clinical trials on transdermal delivery of antipsychotic drugs are available and only delivery systems containing asenapine and blonanserin have shown interesting clinical results in terms of pharmacokinetic data, efficacy, and tolerability. Recently, the transdermal patch formulation of blonanserin was approved in Japan for the treatment of schizophrenia."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Striatal dopamine D2 receptor occupancy induced by daily application of blonanserin transdermal patches: Phase 2 study in Japanese patients with schizophrenia. (PubMed, Int J Neuropsychopharmacol) - "Blonanserin patches (40/80 mg/day) have lower diurnal variability in occupancy than blonanserin tablets (8/16 mg/day) and patches at doses of 40 mg/day and 80 mg/day appear to be suitable alternative for blonanserin tablets at doses of 8 mg and 16 mg/day, respectively. Blonanserin patches represent a potential new treatment option for patients with schizophrenia."

Clinical • Journal • P2 data • CNS Disorders • Psychiatry • Schizophrenia

Prediction methods of drug-drug interactions of non-oral CYP3A4 substrates based on clinical interaction data after oral administrations - Validation with midazolam, alfentanil, and verapamil after intravenous administration and prediction for blonanserin transdermal patch. (PubMed, Drug Metab Pharmacokinet) - "Predicted AUCRs of midazolam, alfentanil and R- and S-verapamil were less than, but not far from observed ratios, suggesting good conservative prediction. These methods were applied to blonanserin transdermal patch, suggesting much smaller interaction with CYP3A4 inhibitors/inducers compared to oral dosage of blonanserin."

Clinical • Journal • CYP3A4

Dainippon Sumitomo Pharma and Nitto Denko joint development phase 2 studies start on the world’s first transdermal patch formulation for schizophrenia treatment (Sumitomo Dainippon) - Dainippon Sumitomo and Nitto Denko have started P2 studies for a transdermal patch formulation of LONASEN (blonanserin), for schizophrenia

New P2 trial • Schizophrenia

Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan. (PubMed, Pharmacopsychiatry) - "BLO-P40+80 may have a good efficacy/safety/tolerability profile for the treatment of patients with acute schizophrenia."

Clinical • Journal • P3 data • Review

Long-Term Safety and Efficacy of Blonanserin Transdermal Patches in Japanese Patients with Schizophrenia: A 52-Week Open-Label, Multicenter Study. (PubMed, CNS Drugs) - P3; "Blonanserin transdermal patches are safe and effective in the long-term treatment of schizophrenia. CLINICALTRIALS."

Clinical • Journal