Vilazodone

FDA Approves Spravato (Esketamine) Nasal Spray as Standalone Treatment for Treatment-Resistant Depression

4 months ago

• The FDA has approved Spravato (esketamine) nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). • Spravato demonstrated rapid and superior improvement in depressive symptoms compared to placebo in clinical trials. • The approval was based on a study where 22.5% of patients achieved remission with Spravato compared to 7.6% with placebo. • Due to risks, Spravato is only available through a restricted program under the supervision of a healthcare provider.

Intra-Cellular Therapies Seeks FDA Approval for Caplyta as Adjunctive MDD Treatment

6 months ago

• Intra-Cellular Therapies has submitted an sNDA to the FDA for Caplyta (lumateperone) as an adjunctive treatment for major depressive disorder (MDD). • The sNDA is supported by positive Phase 3 results, demonstrating significant antidepressant efficacy and a favorable safety profile for Caplyta. • If approved, Caplyta would address a critical need for effective and well-tolerated medicines for the millions of adults with MDD who do not adequately respond to antidepressants alone. • Caplyta, an oral, once-daily atypical antipsychotic, is already approved for schizophrenia and bipolar depression, potentially expanding its utility.

SAINT iTBS Protocol Shows Promise for Bipolar I Depression

7 months ago

• A refined protocol of repetitive transcranial magnetic stimulation (rTMS), SAINT, shows promise in reducing depressive symptoms of bipolar I disorder. • The open-label trial demonstrated a 60% remission rate among participants within one month following the SAINT treatment. • The SAINT protocol was not associated with adverse cognitive effects or the emergence of manic symptoms in the study. • Further investigation is warranted through double-blind, sham-controlled trials with larger samples and extended follow-up.

Antidepressant Vortioxetine Shows Promise in Treating Glioblastoma in Preclinical Studies

8 months ago

• Researchers have identified vortioxetine, an FDA-approved antidepressant, as a potential treatment for glioblastoma, an aggressive brain tumor, due to its ability to cross the blood-brain barrier. • Preclinical studies in cell cultures and mice demonstrated that vortioxetine effectively suppressed glioblastoma cell growth, especially when combined with standard treatments like chemotherapy and radiation. • The research team is preparing for clinical trials to evaluate the efficacy of vortioxetine in human glioblastoma patients, with cautious optimism about its potential to improve treatment outcomes. • Experts caution against self-medication with vortioxetine, emphasizing the need for clinical trials to determine appropriate dosages and confirm its effectiveness and safety in humans.

FDA Approves Cobenfy, a Novel Schizophrenia Treatment Targeting Cholinergic Receptors

8 months ago

• The FDA has approved Cobenfy (xanomeline and trospium chloride) as the first new class of drug for schizophrenia in over 30 years, offering a novel approach to treatment. • Cobenfy targets muscarinic receptors, unlike traditional antipsychotics that focus on dopamine, potentially reducing side effects like weight gain and movement disorders. • Clinical trials demonstrated Cobenfy significantly reduced schizophrenia symptoms compared to placebo, marking a transformative moment in managing this challenging condition. • Expected to launch in late October, Cobenfy offers a new option for adults with schizophrenia, with ongoing studies exploring its potential in Alzheimer's psychosis and other conditions.

Abbott's TRANSCEND Trial to Evaluate DBS for Treatment-Resistant Depression

9 months ago

• Abbott has initiated the TRANSCEND study, a pivotal clinical trial, to assess its deep brain stimulation (DBS) system for treatment-resistant depression (TRD). • The FDA granted Abbott Breakthrough Device designation for DBS in TRD, expediting the review of this innovative technology. • The TRANSCEND study is a multi-center, double-blind, randomized, sham-controlled trial enrolling 100 participants who have failed multiple antidepressant treatments.