The approval was based on the ASPIRE I and II trials that compared the efficacy and safety of esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, to placebo in 449 adults with moderate to severe MDD who had active suicidal ideation and intent.
The applications are supported by positive results from a double-masked, 4-week, pivotal phase 2/3 clinical trial that compared the effects of tasimelteon to placebo in 25 patients with SMS.
The FDA has announced that it is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to include new recommendations about naloxone to the prescribing information.
The FDA has accepted for filing the supplemental New Drug Application (sNDA) for pimavanserin (Nuplazid®; Acadia) for the treatment of hallucinations and delusions associated with dementia-related psychosis.
Dexmedetomidine is currently available as a solution for intravenous infusion for use in clinical anesthesia and sedation in an intensive care setting.
Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).
Positive topline results were announced from the second pivotal phase 3 study evaluating daridorexant (Idorsia), an investigational dual orexin receptor antagonist, for the treatment of insomnia.
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
Acadia Pharmaceuticals has submitted a supplemental New Drug Application to the FDA for pimavanserin (Nuplazid®) for the treatment of hallucinations and delusions associated with dementia-related psychosis.
Centanafadine is a serotonin-norepinephrine-dopamine reuptake inhibitor. The two, 6-week, multicenter, double-blind, placebo-controlled trials (Study 1 and Study 2) evaluated the efficacy and safety of centanafadine sustained-release tablets in approximately 900 adult patients with ADHD.
