botulinum toxin type A (AGN-151607) / AbbVie - LARVOL DELTA

Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Gastroenterology

Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. (PubMed, JACC Clin Electrophysiol) - P2 | "There were no significant differences in the rate of POAF with either dose compared with placebo; however, there was a lower rate of POAF in participants ≥65 years undergoing CABG only and receiving 125 U of AGN-151607. These hypothesis-generating findings require investigation in a larger, adequately powered randomized clinical trial. (Botulinum Toxin Type A [AGN-151607] for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery [NOVA]; NCT03779841); A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A [AGN 151607] Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery; 2017-004399-68)."

Clinical • Journal • Atrial Fibrillation • Cardiovascular

Safety and Efficacy of Botulinum Toxin Type A for Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Patients: Pulmonary Function Test Results From the Phase 2 NOVA Study (AHA 2023) - P2 | "In this analysis of respiratory function, there appeared to be no detrimental effect of AGN-151607 compared with placebo, as evidenced by similar outcomes in PFT parameters and respiratory AE/SAE incidences among treatment arms."

Clinical • P2 data • Surgery • Atrial Fibrillation • Cardiovascular

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (clinicaltrials.gov) - P2 | N=330 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Surgery • Trial completion • Atrial Fibrillation • Cardiovascular

Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Patients: Results From the Phase 2 Nova Study (AHA 2022) - "In this exploratory study, there were no significant differences in the rate of POAF with either dose compared with placebo. However, there was a lower rate of POAF and rehospitalization in patients ≥ 65 years undergoing CABG receiving 125 U of AGN-151607."

Clinical • Late-breaking abstract • P2 data • Atrial Fibrillation • Cardiovascular

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (clinicaltrials.gov) - P2 | N=330 | Active, not recruiting | Sponsor: Allergan | Recruiting ➔ Active, not recruiting

Enrollment closed • Atrial Fibrillation • Cardiovascular

Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study. (PubMed, Am Heart J) - "The NOVA Study will test the hypothesis that injections of AGN-151607 will reduce the incidence of POAF and associated resource utilization. If demonstrated to be safe and effective, the availability of a one-time therapy for the prevention of POAF would represent an important treatment option for patients undergoing cardiac surgery."

Journal • P2 data • Atrial Fibrillation • Cardiovascular • Critical care

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (clinicaltrials.gov) - P2; N=330; Recruiting; Sponsor: Allergan; Trial primary completion date: Oct 2021 ➔ Mar 2022

Clinical • Trial primary completion date • Atrial Fibrillation • Cardiovascular

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (clinicaltrials.gov) - P2; N=330; Recruiting; Sponsor: Allergan; Trial completion date: Sep 2022 ➔ Feb 2023

Clinical • Trial completion date • Atrial Fibrillation • Cardiovascular

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (clinicaltrials.gov) - P2; N=330; Recruiting; Sponsor: Allergan; Trial completion date: Oct 2021 ➔ Sep 2022; Trial primary completion date: Oct 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular