While there is a laundry list of antipsychotic medications for schizophrenia, they are decades old. clinicaltrials.gov/ct2/show/results/NCT02634346. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. While those drugs are numerous, Goff said, they all work in a similar manner — by blocking a receptor on brain cells called D2, which interacts with the chemical dopamine. ISM is a technological advancement that allows for the release of drugs based on in situ formulation of biodegradable matrices after the administration of a liquid carrier. The most common AEs (≥5%) were headache, somnolence, and insomnia. Virtual FDA Advisory Committee Meeting to Review New Drug Application for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder Tentatively Scheduled for Oct. 9, 2020. Secuado [prescribing information]. WASHINGTON, D.C., Sept. 1, 2020 – The American Psychiatric Association (APA) today released a new evidence-based practice guideline to enhance the treatment of patients with schizophrenia. Links will not be permitted. Accessed February 24, 2020. New Agent Approved: Lumateperone Tosylate (ITI-007), Lumateperone is a selective serotonin (5-HT) 5-HT2A receptor antagonist that received approval in December 2019 for the treatment of schizophrenia in adults. Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process. … November 16, 2020 Source: University of Leeds Summary: New research into how a common parasite infection alters human behavior could help development of treatments for schizophrenia … Accessed February 25, 2020. Changes in the key secondary end point, CGI-S, were also statistically significant for both doses.25,26 The most commonly observed AEs were EPS, application-site reactions, and weight gain.25. Serious AEs were observed in 2.5% of the olanzapine treatment group and 3.6% of the olanzapine/samidorphan treatment group during the 6-month trial period.34 A new drug application was approved, and the drug has a Prescription Drug User Fee Act date of November 15, 2020.35,36, Long-acting injectable (LAI) antipsychotics with a longer duration of action are under development to improve adherence in patients with schizophrenia. Source Reference: Koblan K, et al "A non-d2-receptor-binding drug for the treatment of schizophrenia" N Engl J Med 2020; 382: 1497-1506. Results showed that both the 75-mg and 100-mg once-monthly doses demonstrated statistically significant improvements (P <.0001) compared with placebo injections in the PANSS and CGI at 12 weeks.43 Complete results have not yet been published. And taking the … One issue with existing medications is that side effects can make adherence difficult, Koblan said. 0. Lumateperone 60 mg/day demonstrated statistically significant superiority in the change in the Positive and Negative Syndrome Scale (PANSS) total score versus placebo, with a least squares mean change from baseline on the PANSS total score of —14.5 points versus –10.3 points with placebo (P = .022). Practice guideline for the treatment of patients with schizophrenia, second edition. Hear details from the phase II trial of xanomeline-trospium and how it assists in the treatment of acute schizophrenia… It's not fully clear how the drug works, according to Koblan, but it does act through a different mechanism than current antipsychotics. Marlborough, MA, and Paramus, NJ: Sunovion Pharmaceuticals Inc and PsychoGenics Inc; September 27, 2019. news.sunovion.com/press-release/sunovion-and-psychogenics-initiate-diamond-phase-3-clinical-studies-sep-363856. The APA recommends SGAs as first-line treatment of schizophrenia, excluding clozapine due to its AE profile.12 SGAs are preferred over FGAs because they are less often associated with extrapyramidal side effects (EPS), although SGAs are more often associated with metabolic AEs (eg, weight gain, hyperlipidemia, and diabetes mellitus).12 Combination therapy or treatment with clozapine is reserved for patients who have a partial or poor response to standard treatment with SGAs. But, Goff said, they do not ease the "negative" symptoms that plague people with schizophrenia. Experts were hopeful that the findings, published April 16 in the New England Journal of Medicine, will lead to a new treatment option. NOV 20, 2020 7:30 AM PST. Author affiliation: Megan Maroney, PharmD, BCPP, is a clinical associate professor, Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, Piscataway, NJ; clinical psychiatric pharmacist, Monmouth Medical Center, Long Branch, NJ. Accessed November 23, 2019. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis [published correction appears in. Blog / New Drug Approval for Treatment of Schizophrenia, Encouraging News! Leucht S, Barnes TR, Kissling W, Engel RR, Correll C, Kane JM. Boter H, Peuskens J, Libiger J, et al; EUFEST study group. Schwartz MD, Canales JJ, Zucchi R, Espinoza S, Sukhanov I, Gainetdinov RR. He said, "I'm glad to see they're investing in a drug with a new mechanism of action. And because many of the traditional medications used to treat the disorder cause major side effects, those with schizophrenia … Accessed February 18, 2020. Emerging Evidence on Genetics of Schizophrenia Raises Hopes for New Treatment Targets Journal of Clinical Psychopharmacology Presents Translational Science Update . Blocking D2 can lessen psychosis symptoms, but is also responsible for the drugs' most troublesome side effects. Presently, multiple agents are available for the treatment of schizophrenia; however, the majority do not address negative symptoms and cognitive dysfunction, with many patients having debilitating residual symptoms, difficulties with adherence, and drug-related adverse effects. FDA approved new antipsychotic drug for treatment of schizophrenia: Caplyta (lumateperone). The oral pill from Intra-Cellular Therapies should be available in early 2020. That compared with 44% of patients given a placebo. The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Symptoms may come and go, but schizophrenia requires lifelong treatment. , 2019. edisongroup.com/publication/doria-phase-iii-trial-hits-primary-endpoint/23705 D2 can lessen psychosis symptoms, but is also responsible for receiving information from the phase trial... 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