While multiple unmet therapeutic needs remain in psychiatry, many pharmaceutical companies have either discontinued or significantly reduced their drug-development programs for CNS-Disorders. Despite this worrisome trend, several new pharmacological agents, as well as modifications / new formulations of previously approved medications, have been approved by Health Canada over the past years. Other medications have received new indications by Health Canada or are under review by Health Canada. Other medications are currently under review by FDA. The following medications will be reviewed in this presentation:
Intranasal esketamine received breakthrough therapy designation by FDA and is currently under investigation as a treatment for Major Depressive Disorder with imminent risk of suicide.
Rapastinel (formerly known as GLYX-13) is an investigational intravenous formulation of a novel NMDA receptor partial agonist. Rapastinel also received breakthrough therapy designation and fast-track designation by FDA and is under investigation as a treatment for Major Depressive Disorder.
Abilify Maintena™ (aripirazole for prolonged release injection) received an indication for maintenance monotherapy treatment of bipolar I disorder in adult patients.
REXULTI (brexpiprazole) is indicated for treatment of schizophrenia in adults. Brexpiprazole is under review by Health Canada for an indication of MDD.
Latuda® (lurasidone) received an additional indication of ‘the management of the manifestations of schizophrenia in adolescent aged from 15-17 years’.
Latuda® (lurasidone) is under Health Canada review for an indication of bipolar disorder in adolescents.
Suvorexant is under review as a new drug submission by Health Canada
Flibanserin is under Health Canada review. Addyi® (flibanserin) was approved by the FDA in August 2015 for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) and is available through a restricted (ADDYI REMS) program.