Versacloz (clozapine oral suspension) / Jazz - LARVOL DELTA

Increase in sleep slow waves after cortical injections of sodium oxybate and the role of SOM+ interneurons. (Neuroscience 2021) - "For chemogenetic experiments, clozapine-N-oxide (CNO; 0.1mg/kg) or saline was injected i.p. 20min before the infusion of SXB...These results show that SBX promotes SWA, at least in part, by acting directly on the cortex, and this effect involves GABAergic SOM+ interneurons. Our working hypothesis is that SXB potentiates the ability of these cells to inhibit all other cortical cell types via a GABAb mechanism, thus promoting the transition from ON to OFF periods during NREM sleep.; Grant Support: Funded by a grant from Jazz Pharmaceuticals."

CNS Disorders

Treatment options for Parkinson’s disease psychosis (YouTube) - "Stuart Isaacson, MD...gives an overview of the current treatment strategies available to treat Parkinson's disease (PD) psychosis. PD psychosis is a common non-motor symptom of PD characterized by frequent and severe hallucinations or delusions. To treat PD psychosis, it is sometimes necessary to decrease the medications used to control the motor symptoms. Moreover, the treatment is limited by only three available medications (clozapine, quetiapine, pimavanserin) that do not worsen the motor manifestations of PD but have low efficacy. Dr Isaacson also comments on a proof of concept study of a new type of anti-psychotic with the potential to improve treatment. This interview took place during the American Academy of Neurology (AAN) 2021 Annual Meeting."

Interview • Video

Tanner Pharma Group signs Versacloz distribution agreement with Tasman Pharma Inc. (Businesswire) - "Tanner Pharma Group, a global provider of integrated specialty access solutions, has announced the signing of a distribution agreement with Tasman Pharma Inc. The agreement names Tanner as a distributor of Versacloz in areas outside of the United States where the product is not yet registered (excluding Australia, Ireland, and United Kingdom)."

Commercial • CNS Disorders • Schizophrenia

Atypical antipsychotics for Parkinson’s disease psychosis: A systematic review and meta-analysis (Dovepress) - "There is strong evidence that pimavanserin is effective for the treatment of PDPsy. Clozapine is also recommended but should be used with caution due to its side effects. In the future, more well-designed randomized controlled trials (RCTs) are needed to confirm and update the findings reported..."

Retrospective data

FDA: Important updates to the clozapine REMS program (eMPR) - "According to the Food and Drug Administration (FDA), prescribers and pharmacies must be certified in the Clozapine REMS program by February 28, 2019 in order to continue to prescribe or dispense clozapine....Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions."

FDA event