Search results
Results from the WOW.Com Content Network
The long-acting injectable form of paliperidone, marketed as Invega Sustenna in the US, [6] and Xeplion in the EU, [12] was approved by the FDA in July 2009. It was initially approved in the European Union in 2007, for schizophrenia, the extended release form and use for schizoaffective disorder were approved in the EU in 2010, and extension to ...
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years. Cobenfy, manufactured by Bristol Myers Squibb ...
Lumateperone, sold under the brand name Caplyta, is an atypical antipsychotic medication of the butyrophenone class. It is approved for the treatment of schizophrenia as well as bipolar depression, as either monotherapy or adjunctive therapy (with lithium or valproate). [2] It is developed by Intra-Cellular Therapies, licensed from Bristol ...
According to a 2013 meta-analysis of the comparative efficacy and tolerability of 15 antipsychotic drugs it was the most prone of the 15 for causing extrapyramidal side effects. [29] With more than 6 months of use 14 percent of users gain weight. [44] Haloperidol may be neurotoxic. [45] Prolonged use of the drug can lead to mental dependence. [46]
The lack of a warning sent Bristol Myers' shares up 6.3% at $53.28 in premarket trading on Friday. ... FDA's approval was based on data from two studies in which patients on the drug experienced a ...
The KarXT approval comes after decades of no significant treatment advancements for schizophrenia patients. About 3.7 million, or 1.8%, of adults in the U.S. have a lifetime history of ...
Ziprasidone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia as well as acute mania and mixed states associated with bipolar disorder. Its intramuscular injection form is approved for acute agitation in schizophrenic patients for whom treatment with just ziprasidone is appropriate. [11]
Study 1 (NCT04659161) and study 2 (NCT04738123) were 5-week, randomized, double-blind, placebo-controlled, multi-center studies in adults with a diagnosis of schizophrenia according to DSM-5 criteria. [1] [2] The primary efficacy measure was the change from baseline in the positive and negative syndrome scale (PANSS) total score at week 5. [2]