Data from two Phase 3 studies evaluating brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder did not meet the primary endpoint of statistical separation from placebo as measured by the Young Mania Rating Scale at week 3.
Sandoz and Pear Therapeutics announced the launch of reSET-O, a new digital therapeutic for patients aged ≥18 years with opioid use disorder (OUD) currently under clinician care.
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime.
Alprazolam was found to be the most commonly misused benzodiazepine.
Palo Alto Health Sciences announced that the FDA has granted clearance to Freespira, a new digital therapeutic for the treatment of PTSD.
Sandoz and Pear Therapeutics announced that the FDA has granted clearance for reSET-O, the first prescription digital therapeutic for patients with opioid use disorder.
Lumateperone and follow-on compounds are also being evaluated for bipolar depression, behavioral disturbance associated with dementia, sleep disturbances associated with neuropsychiatric disorders, and other neuropsychiatric conditions including major depressive disorder and autism.
Sandoz and Pear Therapeutics announced the availability of reSET, the first prescription digital therapeutic for patients with substance use disorder.
NeuroRx announced that the FDA has granted Breakthrough Therapy designation to NRX-101 for the treatment of severe bipolar depression with acute suicidal ideation.
If approved, Zulresso would be the first drug approve for the treatment of postpartum depression.
