FDA: Important Updates to the Clozapine REMS Program
Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions.
Schizophrenia
NDA for Transdermal Patch Formulation of Asenapine Submitted to FDA
HP-3070 is being developed by Hisamitsu Pharmaceuticals in Japan in conjunction with its US subsidiary, Noven Pharmaceuticals.
FDA to Review Lumateperone for Treatment of Schizophrenia
Lumateperone and follow-on compounds are also being evaluated for bipolar depression, behavioral disturbance associated with dementia, sleep disturbances associated with neuropsychiatric disorders, and other neuropsychiatric conditions including major depressive disorder and autism.
Perseris Now Available for the Treatment of Schizophrenia in Adults
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
NDA Submitted for Novel Schizophrenia Treatment Lumateperone
Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation.
Once-Monthly Perseris Approved for the Treatment of Schizophrenia
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
Aristada Initio Regimen Approved for Initiation of Schizophrenia Treatment
Prior to this approval, the Aristada initiation regimen consisted of taking oral aripiprazole for 21 consecutive days starting with the first Aristada dose.
Substance Use Disorders Linked to Conversion to Schizophrenia
This prospective cohort study included a population-based sample of 2,539 individuals born in Denmark with an incident diagnosis of schizotypal disorder and without a previous diagnosis of schizophrenia.
FDA Grants Fast Track Status to Lumateperone for Schizophrenia
In two studies, lumateperone showed a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale, or PANSS, total score.
Medication Review Reveals Patient Was on Wrong Drug for 10 Years
The case involved a 69-year old patient with paranoid schizophrenia who was brought to the emergency department following violent behavior against the staff at the nursing facility he resided in.
