This week there’s more COVID vaccine developments; A first-of-its-kind trial assessing a drug for preventing COVID in long term care facilities; A cannabidiol treatment gains another indication; Depression treatment gains indication for major depressive disorders with acute suicidal ideation or behavior; And the FDA requests more information for their review of the peanut allergy treatment, Viaskin.
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.
Incidence and recurrence of depression, change in mood scores did not differ from placebo for adults ≥50.
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.
An FDA database revealed that people who receive Botox injections report less depression.
Acetaminophen, acetylsalicylic acid accounted for 48.0, 18.5% of cases; 64.5, 32.6% of deaths.
Melatonin and other melatonin receptor agonists have demonstrated efficacy in the treatment of circadian rhythm disorders in both pediatric and adult populations.
Guideline offers simple practice changes that may increase effectiveness of tobacco-dependence pharmacotherapy.
The FDA has approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates; Jazz Pharmaceuticals) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged ≥7 years with narcolepsy.
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.
