Axsome Therapeutics: FDA Accepts NDA Resubmission for AXS-07 for Acute Treatment of Migraine
Based on its acceptance of the resubmission, FDA has assigned a PDUFA action goal date of January 31, 2025 for AXS-07.
Lecanemab Will Be Evaluated in Preclinical Alzheimer Disease with Novel Study Design
The AHEAD study program will use plasma biomarker screening, novel PET agents, and other unique approaches to assessing lecanemab effect at the earliest stage of disease.
Donanemab FDA AdComm Hearing Scheduled for June 10, Eli Lilly Says
The AdComm plans to review data from the TRAILBLAZER-ALZ 2 phase 3 clinical trial that served as the foundation for Eli Lilly's original BLA submission to the FDA.
Axsome's Novel AXS-07 Formulation Effective Against Migraine in Pooled Phase 3 Study Analysis
The novel meloxicam/rizatriptan combination is thought to act via CGRP inhibition and provided significant and sustained headache pain freedom in both studies.
Erenumab Rx Early in Episodic Migraine Found Superior to Oral Prophylactic Agents for Efficacy, Tolerability, Adherence
The phase 4 APPRAISE trial found greater efficacy with erenumab after failure with 1 or 2 other preventives vs ongoing treatment with the nonspecific oral agents.
Lundbeck Moves PACAP-Targeting Antibody into Multinational Phase 2b Clinical Trial
PROCEED will assess the efficacy and safety of the PACAP antagonist as a migraine preventive in individuals who have failed to get relief from up to 4 agents.
Lilly Investigational Alzheimer Agent Donanemab Phase 3 Findings Under FDA Review
The surprise request for review of the phase 3 TRAILBLAZER-ALZ-2 clinical trial findings will delay the original PDUFA timing beyond first quarter 2024.
Functional Deficits Poststroke Found More Pronounced in Study Group with Lower Mean Oxygen Saturation During Sleep
At 3 months following ischemic stroke, lower mean oxygen saturation but not apnea-hypopnea index was associated with functional deficits, according to a French research team.
Apixaban Reduced Risk of Stroke in Subclinical Afib Relative to Aspirin but with Greater Risk of Bleeding: ARTRESIA Trial
In apixaban-treated participants, risk of stroke or systemic embolism was reduced by 37%; the risk of disability or fatal stroke declined by 49%, but with noted bleeding risk.
Migraine-related Stigma is Common and Impacts Level of Disability, Quality of Life
Reports of migraine-related stigma were common in a recent population-based study, with nearly one-third reporting the experience often/very often.
Milvexian Added to Standard DAPT Fails to Reduce Stroke Risk, May Increase Risk of Bleeding
AXIOMATIC-SSP is considered the largest clinical trial of activated factor XIa inhibition added to standard antiplatelet therapy for secondary stroke prevention.
Nerivio Neuromodulation Device Maintains Efficacy, Safety at 1 Year of Consistent Use for Migraine
Among study participants with migraine, investigators observed consistent and persistent device efficacy for pain relief, pain freedom, and functional disability freedom.
Ubrogepant Taken During Migraine Prodrome Reduces Headache Severity: Phase 3 Clinical Trial
Ubrogepant 100 mg taken during the migraine prodrome significantly reduced onset of moderate or severe headache for 24 hours after study-drug dose.
Axsome's AXS-05 Significantly Reduced Risk of Relapse in Alzheimer Agitation in Phase 3 ACCORD Trial
Findings from phase 3 ACCORD clinical trial demonstrated rapid and sustained clinical response in patients with Alzheimer disease agitation with no new safety signals reported.
Migraine Medicine in Motion: Jessica Ailani, MD, Discusses CGRP, PACAP, and Patient Selection
Ailiani, director of MedStar Georgetown Headache Center, focuses on optimizing treatment with CGRP inhibitors and where research on PACAP-targeting agents stands now.
Recreational Drug Use Linked to 9-Fold Higher Rate of Adverse Outcomes in Intensive Cardiac Care
Various illicit substances were detected in urine assays of 1 in 10 patients admitted to cardiac intensive care, according to findings of new French study.
Novel Neurostimulation Device Shows Significant Benefit for Migraine
The device from Nexalin Technology outperformed placebo on key measures of pain relief, sleep quality, anxiety, and quality of life.
Asundexian Granted FDA Fast Track Designation for Stroke Prevention in Patients with AF
Bayer's investigational FXIa inhibitor is currently being studied in a large-scale phase 3 development program expected to enroll more than 27 000 participants.
Eisai Seeks Traditional FDA Approval for Lecenemab with Supplemental BLA Filing
Approval of lecanemab under FDA's accelerated pathway requires the company to provide phase 4 study evidence to confirm the agent's clinical effect.
