Serotonin

UCLA Study Reveals SSRIs May Enhance Immune Response Against Cancer

20 hours ago

• UCLA researchers discovered that selective serotonin reuptake inhibitors (SSRIs) can enhance T cells' ability to fight cancer, reducing tumor size by more than half in multiple cancer models. • The study, published in Cell, demonstrated SSRIs' effectiveness against melanoma, breast, prostate, colon, and bladder cancers in both mouse and human tumor models. • Combining SSRIs with existing cancer immunotherapies showed promising results, suggesting potential for repurposing these widely used antidepressants as cancer treatments.

FDA Approves Brekiya: First DHE Autoinjector for Acute Migraine and Cluster Headache Treatment

8 days ago

• The FDA has approved Amneal Pharmaceuticals' Brekiya, the first and only dihydroergotamine (DHE) autoinjector for acute treatment of migraine and cluster headaches in adults. • Brekiya provides patients with the same medication used in hospitals and emergency rooms in a convenient, self-administered form that requires no refrigeration, assembly, or priming. • The approval addresses significant unmet needs, as headache is the fourth most common reason for ER visits, affecting approximately 39 million Americans with migraine and up to 1 million with cluster headache.

Fremanezumab Shows Dual Efficacy in Treating Both Migraine and Depression in Landmark Trial

17 days ago

• A groundbreaking clinical trial demonstrates that fremanezumab, a CGRP-targeting monoclonal antibody, significantly reduces both migraine frequency and depressive symptoms in patients with comorbid conditions. • The UNITE study involving 540 patients across 12 countries showed fremanezumab reduced monthly migraine days by 5.1 compared to 2.9 with placebo, with 40% of treated patients achieving at least 50% reduction in migraine days. • This represents the first placebo-controlled trial to demonstrate significant improvements in both migraine and depression with a single pharmacological intervention, potentially reducing the cumulative burden on patients.

Tavapadon Shows Promise in Phase 3 Trials for Parkinson's Disease with Improved Motor Function and Safety Profile

a month ago

• The TEMPO-1 and TEMPO-2 trials demonstrated that tavapadon, a selective D1/D5 dopamine receptor agonist, significantly improved motor function in newly diagnosed Parkinson's disease patients compared to placebo. • Tavapadon's once-daily dosing regimen and targeting of D1/D5 receptors may offer advantages over traditional D2/D3 agonists, with lower incidence of impulse control disorders, somnolence, and other dopaminergic side effects. • The TEMPO-3 trial showed tavapadon's efficacy as an adjunctive therapy, increasing "on" time by 1.1 hours in patients with advanced Parkinson's disease who experience motor fluctuations while on levodopa.

Vanda Pharmaceuticals Submits NDA for Novel Antipsychotic Bysanti to Treat Bipolar I Disorder and Schizophrenia

2 months ago

• Vanda Pharmaceuticals has submitted a New Drug Application to the FDA for Bysanti (milsaperidone), seeking approval for the treatment of acute bipolar I disorder and schizophrenia. • Bysanti is a novel atypical antipsychotic that works by interacting with multiple neurotransmitter receptors including alpha-adrenergic, serotonin, and dopamine receptors in the brain. • If approved, Bysanti could reach the US market by 2026, with potential patent exclusivity extending into the 2040s, while Phase III trials for its use in major depressive disorder are currently underway.

atai Life Sciences Advances Psychedelic Therapy Pipeline with Key Clinical Milestones and Extended Financial Runway

2 months ago

• atai Life Sciences has dosed the first patient in its Phase 2 Elumina trial of VLS-01 (buccal film DMT) for treatment-resistant depression, with topline data expected in Q1 2026. • The company initiated a Phase 2 trial of EMP-01 (oral R-MDMA) for social anxiety disorder and completed enrollment in Beckley Psytech's Phase 2b study of BPL-003 for treatment-resistant depression. • A recent equity offering raised $59.2 million, extending atai's operational runway into 2027, well beyond anticipated data readouts from its core clinical programs.

European Commission Approves Rxulti for Adolescent Schizophrenia Treatment

2 months ago

• The European Commission has approved Rxulti (brexpiprazole) for treating schizophrenia in adolescents aged 13 years and older, expanding its previous 2018 approval for adults. • Approval was based on a 6-week clinical trial of 316 adolescents showing significant symptom reduction as measured by PANSS scores, with a safety profile consistent with adult patients. • Adolescent-onset schizophrenia often has poorer prognosis than adult-onset, with more chronic and severe symptoms, making this new treatment option particularly significant for young European patients.

Sumitomo's Novel Schizophrenia Drug Ulotaront Fails to Meet Primary Endpoint in Phase 3 Trials

4 months ago

• Sumitomo Pharma America's ulotaront (SEP-363856), a novel TAAR1 and 5-HT1A agonist, failed to demonstrate statistical significance versus placebo in two Phase 3 trials for acute schizophrenia. • Despite showing favorable safety profile with fewer metabolic side effects compared to current antipsychotics, the drug's efficacy was masked by an unexpectedly high placebo response in the DIAMOND 1 and 2 studies. • The setback occurs amid ongoing development of other promising schizophrenia treatments, including Karuna's KarXT and Minerva's roluperidone, which are advancing toward potential market approval.

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.

MindMed Advances MM120 for GAD with Phase 3 Trials Underway

5 months ago

• MindMed has initiated Phase 3 trials for MM120 ODT, a novel LSD-based treatment for generalized anxiety disorder (GAD). • The Panorama study expands on the Voyage study by including a 50-microgram dose arm to mitigate functional unblinding bias. • MM120 demonstrated rapid and sustained clinical response in Phase 2 trials, with significant improvements in anxiety reduction. • The FDA has granted Breakthrough Therapy Designation for MM120, expediting regulatory review and development timelines.

Drug Development Updates