ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
The FDA has accepted for Priority Review the Biologics License Application for aducanumab (Biogen) for the treatment of Alzheimer disease.
Treatment with deutetrabenazine was found to be beneficial for both younger (<55 years) and older (≥55 years) patients with tardive dyskinesia, according to findings from a recently published post hoc analysis.
The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
Results showed a mean change from baseline of -9.28 points (95% CI, -10.23 to -8.32) on the HAM-A total score in patients treated with troriluzole compared with -9.35 points (95% CI, -10.34 to -8.36) with placebo (P =.917).
The update was prompted by an FDA review of 10 cases of constipation in clozapine-treated patients that resulted in serious complications.
While claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, such as vulnerability to opioid overdose, were not communicated.
The FDA has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder.
Currently, there is no FDA-approved therapy to treat the negative symptoms of schizophrenia.
