Teva, Medincell's schizophrenia drug succeeds in late-stage study
(Reuters) -Israel-based Teva Pharmaceuticals and French partner Medincell said on Wednesday their experimental schizophrenia drug had met its main goal of reducing the severity of symptoms in a late-stage study.
U.S.-listed shares of Teva were up 3.3% at $14.41 in premarket trading.
The companies hope that the drug - an under-the-skin version of a generic antipsychotic medicine called olanzapine - can be used as a once-monthly treatment for patients with the chronic mental disorder.
The drug, called TEV-'749, met the 675-patient study's main goal of reducing the severity of symptoms, compared with a placebo, when measured on a widely used scale known as Positive and Negative Syndrome Scale.
The disorder affects an estimated 3.5 million people in the United States and its symptoms include delusions, hallucinations, disorganized speech, trouble with thinking and lack of motivation.
The drug uses Medincell's proprietary technology to provide a controlled, steady release of olanzapine, which is commonly used as a treatment for schizophrenia but is tied to the risk of post-injection delirium or sedation syndrome (PDSS).
The companies said there were no cases of PDSS reported in the study.
PDSS causes a sudden and unexpected onset of delirium or sedation within the first several hours of treatment and is associated with long-acting injections administered into a muscle.
Other treatments for the disease include Vanda's Fanapt and other generic drugs such as quetiapine and aripiprazole.
Bristol Myers is developing a schizophrenia drug called KarXT, whose U.S. FDA approval decision is expected in September.
Separately on Wednesday, Teva reported a smaller-than-expected rise in first-quarter profit, citing higher impairments of tangible assets.
(Reporting by Puyaan Singh in Bengaluru; Editing by Devika Syamnath)