Secuado (asenapine transdermal) / Hisamitsu - LARVOL DELTA

Efficacy of HP-3070, A Once-Daily Asenapine Transdermal System, in the Treatment of Adults with Schizophrenia: A PANSS Five-Factor Analysis. (PubMed, Neuropsychiatr Dis Treat) - "Treatment effect size for the positive symptom factor using Cohen's d (95% confidence intervals) was 0.39 (0.17, 0.61) for HP-3070 7.6mg/24h and 0.45 (0.20, 0.64) for HP-3070 3.8mg/24h. Post hoc analysis using a PANSS five-factor model suggests that HP-3070 may address a broad range of symptoms in people with schizophrenia."

Clinical • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study. (PubMed, J Clin Psychiatry) - P3 | "These findings suggest HP-3070 has a specific antihostility effect in patients with schizophrenia. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT02876900; EudraCT number: 2015-005134-21."

Journal • P3 data • Retrospective data • Anesthesia • CNS Disorders • Psychiatry • Schizophrenia

Effect of the HP-3070 Transdermal System (Secuado ) on Symptoms of Hostility in Adults with Schizophrenia. (PubMed, CNS Spectr) - "In this post hoc analysis, HP-3070 was superior to placebo in reducing hostility in patients with schizophrenia, even after adjusting for covariates, suggesting that these effects are at least partially independent of general antipsychotic effects or of effects on sedation or akathisia. These findings suggest that HP-3070 may have a specific anti-hostility effect in patients with schizophrenia."

Journal • Anesthesia • CNS Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Pharmacokinetic Profile of the Asenapine Transdermal System (HP-3070). (PubMed, J Clin Psychopharmacol) - "HP-3070 showed a predictable absorption profile with limited variability, with an area under the curve similar to that of sublingual asenapine. Based on these PK metrics, HP-3070 steadily delivers asenapine with lower peaks and troughs than sublingual administration of asenapine."

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

In brief: An asenapine patch (Secuado) for schizophrenia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

Effects of Antipsychotics on Arrhythmogenic Parameters in Schizophrenia Patients: Beyond Corrected QT Interval (Dovepress) - "According to our results, the prediction of the risk of sudden cardiac death by each index was inconsistent. We should evaluate the predictive factor of ventricular arrhythmia according to various electrocardiogram indexes because QTc alone could not identify the risk of sudden cardiac death."

Retrospective data • CNS Disorders • Schizophrenia

Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study. (PubMed, J Clin Psychiatry) - P3 | "HP-3070 7.6 mg/24 h and 3.8 mg/24 h doses were efficacious and well tolerated. As the first transdermal antipsychotic patch available in the US, HP-3070 offers a novel treatment option for people with schizophrenia."

Clinical • Journal • P3 data • CNS Disorders • Dermatology • Pruritus • Psychiatry • Schizophrenia • Urticaria

Results from Pivotal, Phase 3 Trial for SECUADO (asenapine) Published in Journal of Clinical Psychiatry (Businesswire) - P3, N=614; NCT02876900; Sponsor: Noven Pharmaceuticals, Inc.; "Noven Pharmaceuticals, Inc....today announced publication of the results from a pivotal, phase 3 trial, which showed that SECUADO® (asenapine) transdermal system demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total score at Week 6 versus placebo in adult patients with schizophrenia....SECUADO achieved the primary endpoint, demonstrating statistically significant improvement in Positive and Negative Syndrome Scale (PANSS) total score change from baseline to Week 6 compared to placebo. After six weeks of treatment, the difference in the least squares mean (LSM) (SE) change from baseline in PANSS total score was -4.8 (1.634) and -6.6 (1.630) for the SECUADO 7.6 mg/24h and 3.8 mg/24h groups, compared with placebo."

P3 data • CNS Disorders • 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

Lumateperone (Caplyta) for schizophrenia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

Transdermal Asenapine in Schizophrenia: A Systematic Review. (PubMed, Patient Prefer Adherence) - "There are several formulations of transdermal asenapine but only Secuado has been approved for clinical use...Transdermal asenapine was only tested in one randomized, placebo-controlled study of acute psychosis in schizophrenia. It was superior to placebo at week 6 with nearly one-third of patients experiencing >30% improvement in total PANSS score which translates in a number needed to treat (NNT) of 9."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Asenapine Antipsychotic Patch Provides Predictable Absorption With Less Fluctuation (Psych Congress Network) - P3, N=607; NCT02876900; Sponsor: Noven Pharmaceuticals, Inc.; "HP-3070, the asenapine transdermal system, has a more predictable absorption profile and lower peak-to-trough fluctuations than sublingual asenapine, according to a poster presented at Psych Congress 2020....Findings regarding the pharmacokinetics of the asenapine patch stemmed from 3 open-label, randomized phase 1 studies and 1double-blind, randomized, phase 3 study involving adults with schizophrenia....Systemic treatment-emergent adverse events with the asenapine patch were consistent with sublingual asenapine, according to the abstract. Treatment discontinuations due to application site reactions or skin disorders were infrequent. The asenapine patch was efficacious, safe, and well-tolerated in adults with schizophrenia, researchers concluded, and provides a novel treatment option."

P1 data • P3 data • CNS Disorders • Schizophrenia

Surface-engineered nanoliposomes with lipidated and non-lipidated peptide-dendrimeric scaffold for efficient transdermal delivery of a therapeutic agent: Development, characterization, toxicological and preclinical performance analyses. (PubMed, Eur J Pharm Biopharm) - "The current study aimed to develop novel peptide dendrimer (PD)-conjugated nanoliposomal formulations of asenapine maleate (ASP) for improvement in the transdermal delivery and pharmacokinetic profile of the drug...Stability studies indicated that the formulations were stable up to relatively stable with respect to size, ZP and drug content for 4 months at the tested conditions. This study demonstrates that the developed PD-conjugated nano-liposomal formulations can effectively serve as a transdermal delivery strategy for ASP."

Journal • Preclinical

Up-to-date Expert Opinion on the safety of recently developed antipsychotics. (PubMed, Expert Opin Drug Saf) - "Qualitative synthesis followed an electronic search made inquiring of the following databases: MEDLINE, Embase, PsycINFO and the Cochrane Library from inception until March, 2020, combining free terms and MESH headings for the topics of TGA and recently developed and/or marketed antipsychotics as following: ((safety OR adverse events OR side effects) AND ((brexpiprazole OR cariprazine OR inhaled loxapine OR lumateperone (ITI-007) OR lurasidone OR pimavanserin OR roluperidone (MIN-101) OR transdermal patch asenapine)). Overall, newer antipsychotics display a good safety profile, with a well-demonstrated lower metabolic liability compared to second-generation antipsychotics. Furthermore, TGA appear to specifically target negative symptomatology and improving cognitive domains."

Clinical • Journal • CNS Disorders • Psychiatry

Transdermal Asenapine in Schizophrenia: A Systematic Review (Dovepress) - "This profile suggests that asenapine may be of particular value off label for bipolar depression, anxiety, and aggression. Transdermal asenapine was only tested in one randomized, placebo-controlled study of acute psychosis in schizophrenia. It was superior to placebo at week 6 with nearly one-third of patients experiencing > 30% improvement in total PANSS score which translates in a number needed to treat (NNT) of 9."

Review • CNS Disorders • Schizophrenia

Recent advances in the development of asenapine formulations. (PubMed, Expert Opin Drug Deliv) - "Nonetheless, most of these studies are still limited to the research laboratory level and face multiple hurdles before making into the market. Attaining controllability and reproducibility for the production of novel formulations is needed to enable its transition from bench to bedside."

Journal • CNS Disorders • Schizophrenia

[VIRTUAL] Pharmacokinetic Profile of Asenapine Transdermal System HP-3070: The First Antipsychotic Patch in the US (ASCP 2020) - "Overall, HP-3070 exhibited a consistent, dose-dependent PK profile that was unaffected by site of administration or race. Based on AUC, HP-3070 3.8 mg/24h and 7.6 mg/24h correspond to 5 mg and 10 mg doses BID of SL asenapine, respectively. While AUC was similar to that of SL asenapine, HP-3070 PK exhibits a more predictable absorption profile and lower peak-trough fluctuations."

PK/PD data • CNS Disorders • Schizophrenia

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Novel Coronavirus Disease

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Infectious Disease • Novel Coronavirus Disease

146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: A Phase 3, Randomized, Placebo-Controlled, Inpatient Study. (PubMed, CNS Spectr) - "In this study, HP-3070 was efficacious, safe, and well-tolerated for treating schizophrenia in adults; both doses met primary and key secondary endpoints. As the first transdermal antipsychotic patch in the US, HP-3070 will provide patients a novel treatment option."

Clinical • Journal • P3 data • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

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Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia, is now available in the U.S. (Businesswire) - "Noven Pharmaceuticals...announced that SECUADO® (asenapine) transdermal system, the first-and-only transdermal patch formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with schizophrenia, is now available by prescription in the U.S."

Launch US

Notification of marketing of Secuado in the US (transdermal, schizophrenia treatment patch, development code: HP-3070) (Hisamitsu Press Release) - "Hisamitsu Pharmaceutical Co., Inc....announces that Noven Pharmaceuticals, Inc....launched Secuado®, Transdermal, Schizophrenia treatment patch (Development code: HP-3070, Generic name: Asenapine maleate, hereinafter referred to as 'the product') in the US from March 2, 2020."

Launch US

Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070 (SECUADO), for Schizophrenia: A Phase 3, Randomized, Placebo-Controlled, Inpatient Study (SIRS 2020) - "Discussion In this study, HP-3070 was efficacious, safe, and well-tolerated for treating schizophrenia in adults; both doses met primary and key secondary endpoints. As the first transdermal antipsychotic patch in the US, HP-3070 will provide patients a novel treatment option."

Clinical • P3 data

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