FDA Committees Vote on Esketamine Nasal Spray for Treatment-Resistant Depression
If approved by the FDA, an esketamine nasal spray would provide a new mechanism of action for treating treatment-resistant depression.
All articles by Diana Ernst, RPh
FDA Rejects Opioid System Modulator NDA for Depression Treatment
The FDA has issued a Complete Response Letter to Alkermes regarding the New Drug Application for ALKS 5461, an investigational adjunctive treatment for major depressive disorder.
FDA: Important Updates to the Clozapine REMS Program
Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions.
Psychiatric Adverse Effects of Disease-Modifying Therapies Assessed in MS Patients
The primary outcome measure of the study was the frequency of any adverse psychiatric effect observed during treatment with one of these agents.
Guidelines for Managing Perimenopausal Depression Now Available
The first-ever guidelines for the evaluation and treatment of perimenopausal depression have been published.
Lithium Efficacy, Safety Examined in Children, Adolescents With Bipolar Disorder
With regard to safety, treatment with lithium in this patient population was considered “generally safe, at least in the short term.”
Dasotraline Effective in Phase 3 Binge Eating Disorder Trial
The results from this trial follow similar positive findings from a flexible-dose study of dasotraline.
Withdrawal Symptoms Following SNRI Discontinuation Investigated
Results showed that discontinuation of any SNRI was associated with withdrawal symptoms, with the highest prevalence linked to venlafaxine and desvenlafaxine.
Incidence of Extrapyramidal Symptoms Higher With Certain Antidepressants
The use of certain antidepressants may put patients at increased risk for extrapyramidal symptoms.
Acadia Addresses Concerns Over Nuplazid Safety in Parkinson Disease Patients
Concerns over Nuplazid were initially voiced in a CNN article in early April which reported that the drug had been associated with over 700 deaths since its launch in March 2017.
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