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.
All articles by DaHee Han, PharmD
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.
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.
The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products.
NeuroPointDX announced the availability of the NPDX AA test, the first objective blood test that identifies metabolic subtypes associated with ASD in children as young as 18 months old.
Quillivant XR, a central nervous system stimulant, is indicated to treat ADHD in patients aged 6 years and older.
Takeda announced that the FDA has approved a labeling update for Trintellix to include new head-to-head clinical data comparing it to Lexapro for improving treatment-emergent sexual dysfunction.
The FDA has accepted the supplemental New Drug Application for Vraylar as a treatment for depressive episodes associated with bipolar I disorder in adults.
Transcranial magnetic stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain.
Currently, the Advisory Committee on Immunization Practices (ACIP) recommends pregnant women receive the Tdap vaccination to prevent pertussis infection.
The FDA stated that the dasotraline NDA cannot be approved in its current form and is requiring additional data to further assess the efficacy and tolerability of the drug.
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
Jornay PM utilizes the proprietary Delexis drug delivery platform which consists of 2 functional film coatings: the first layer delays the initial drug release for up to 10 hours and the second layer helps control the release rate of the active ingredient throughout the day.
Results showed an increased risk of bleeding with SRIs by 1.16-2.36 times with an even higher 3.17- to 10.9-fold risk with concomitant NSAIDs.
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
Drinking sugary beverages has been previously linked to markers of preclinical Alzheimer disease, but the risk associated with consuming added sugars is not established.
Although treatment with nabilone significantly improved agitation, cognition, and nutrition, the authors cautioned that sedation should be closely monitored.
In the previous SPRINT study, researchers compared an intensive BP reduction strategy (target systolic BP <120 mmHg) vs standard BP reduction strategy (target systolic BP <140 mmHg).
Given the lack of differences seen via the NIS, the authors suggested that subjective questionnaires may not be a trustworthy method to assess possible statin-associated cognitive deficits.
Adults with depressive symptoms and apathy in middle and late life were at a higher risk for conversion to mild cognitive impairment (MCI) and dementia.
The genetically-mediated effects of angiotensin-converting enzyme (ACE) inhibitors showed an improvement in cognition in patients with Alzheimer disease dementia but not in functionality.
The analysis suggests a beneficial effect of aducanumab on functional and cognitive domain scores in adults with Alzheimer disease.
As the neurodegenerative processes of Alzheimer disease and Parkinson disease are different, early cognitive impairment also present differently in these diseases.
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