Alkermes plc worked its way through a complete response letter (CRL) issued in late 2020 as the FDA has approved Lybalvi (olanzapine and samidorphan) for treating adults with schizophrenia and bipolar I disorder. The once-daily, oral antipsychotic treatment, the company’s first, is for maintenance monotherapy or acute treatment of manic or mixed episodes and as a monotherapy or adjunct to lithium or valproate. The therapy had a June 1 PDUFA date.
LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s.
One of the keys to making a schizophrenia drug work is reducing the side effects, which, if they are powerful enough, will often cause patients to cease the treatment. Laxminarayan Bhat, Reviva Pharmaceuticals Holdings Inc.’s CEO, told BioWorld that new phase II data of the company’s lead candidate shows the drop-out rate was low compared to other schizophrenia drugs.
Researchers from Sunovion Pharmaceuticals Inc. presented early clinical data for SEP-363856, a novel trace amine receptor 1 agonist with serotonin 5-HT1A activity, being developed for the treatment of patients with schizophrenia.
HONG KONG – Researchers at Ben-Gurion University of the Negev (BGU) in Israel have developed a way to instantly monitor blood levels of the antipsychotic drug clozapine. BGU’s solution is based on an electrochemical microsensor developed by Hadar Ben-Yoav from BGU’s Department of Biomedical Engineering and Ilse Katz Institute for Nanoscale Science and Technology.
San Diego-based Neurocrine Biosciences Inc.’s good-and-bad top-line phase II data with d-amino acid oxidase inhibitor luvadaxistat, also known NBI-1065844 and TAK-831, in schizophrenia likely came as little surprise to many, given earlier experience in the general pathway.
Recently published findings in JAMA Psychiatry related to the sharply increased risk of death from COVID-19 in people with schizophrenia put the spotlight on drug development in the space, which has been steadily heating up the past few years.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.