Kv1.5 blockers(Voltage-gated potassium channel subunit Kv1.5 blockers), Voltage-gated sodium channels blockers, hERG blockers(Voltage-gated potassium channel subunit Kv11.1 blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Atrial FibrillationArrhythmias, Cardiac

Inactive Indication

Atrial arrhythmiaAtrial Flutter

Originator Organization

Correvio Pharma Corp.

Active Organization

Aspen Pharmacare Holdings Ltd.

Merck Sharp & Dohme (China) Ltd.

Advanz Pharma Corp. Ltd.

+ [5]

Inactive Organization

Astellas Pharma, Inc.ATCO Corp.

License Organization

Correvio Pharma Corp.

Merck & Co., Inc.

Astellas Pharma, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

European Union (01 Sep 2010),

Atrial Fibrillation

RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Molecular FormulaC20H32ClNO4

InChIKeyJMHYCBFEEFHTMK-IIUXMCBISA-N

CAS Registry748810-28-8

Clinical Trials associated with Vernakalant Hydrochloride

NCT04748991

/ Not yet recruitingPhase 3IIT

Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients

Post-operative atrial fibrillation is a common problem post cardiac surgery with rates exceeding 30%. Atrial fibrillation has multiple adverse effects on cardiac hemodynamics and can lead to hypotension, diminished end organ perfusion and lengthen the stay in ICU. Amiodarone is the medication of choice used for pharmacological cardioversion and can be used with vasoactive medications. Intravenous amiodarone is associated with hypotension and end organ perfusion requiring escalation in vasoactive support. Vernakalant is novel anti-arrhythmic agent approved in Canada for cardioversion of atrial fibrillation that primarily works on atrial channels and has no effect on contractility or vasodilation. Clinical trials have proved good efficacy of Vernakalant in conversion of paroxysmal atrial fibrillation however there is no comparison of Amiodarone to Vernakalant in post-operative cardiac surgery. We plan to perform a clinical trial comparing Vernakalant to amiodarone in post-cardiac surgery patients with a primary outcome of cardioversion at 90 minutes. Secondary outcomes will follow duration of vasoactive medications, days in ICU and economics.

Start Date01 Sep 2024

Sponsor / Collaborator

University of Calgary

NCT04485195

/ CompletedPhase 4IIT

RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department

The objective is to compare IV vernakalant to IV procainamide for the ED management of acute AF patients. If vernakalant proves to be more effective, faster, and safer than IV procainamide, this will give clinicians an important alternative for pharmacological cardioversion of acute AF. The investigators propose a pragmatic comparative effectiveness trial entailing an open label, randomized controlled trial at 12 large Canadian EDs. Study subjects will be randomized to 1 of 2 treatment arms: 1) Patients will receive an initial infusion of 3mg/kg of IV vernakalant over 10 minutes, followed by a second dose of 2mg/kg over 10 minutes, if necessary, or 2) Patients will receive a continuous infusion of 15mg/kg of IV procainamide over 60 minutes. The primary aim will be to compare conversion to normal sinus rhythm between the two drugs. The investigators will include stable patients presenting with an episode of acute AF of at least 3 hours duration, where symptoms require urgent management and where immediate cardioversion is a reasonable option. Using the integrated consent model, research assistants will obtain verbal consent from eligible patients.

Start Date17 Jun 2021

Sponsor / Collaborator

Ottawa Hospital Research Institute

NCT03005366

/ CompletedPhase 4

Randomized Clinical Trial to Study Pharmacological Cardioversion of Paroxysmal Atrial Fibrillation by Vernakalant and Flecainide

The main objective of this project is to study the efficacy and the mechanistic value of blocking both atrial specific and atria-preferential dynamics of ionic currents to terminate paroxysmal atrial fibrillation (AF).
The hypothesis is that a drug blocking atrial specific and atria-preferential dynamics of ionic currents (IK,ACh - acetylcholine sensitive K+ current - and INa - inward sodium current - , respectively) will be more effective to terminate paroxysmal AF episodes with fast atrial activation rates, than a classical INa blocker, which will be more effective to terminate AF episodes with slower activation rates.
The investigators will include patients without structural heart disease and short-lasting AF episodes (<48 h.). Double blind and single center study, in which patients will be randomly assigned to a cardioversion group using intravenous flecainide or to an atria-preferential and atrial-specific blockade group using intravenous vernakalant. Patients will be routinely monitored in the electrophysiology room to acquire both 12-lead digitized ECG signals and non-invasive body surface potential mapping. Atrial signals will be extracted from both the multisite body surface and ECG recordings to obtain temporal and spectral parameters, and measure organization and atrial rate in both groups. The results obtained in the clinical setting will be studied in mathematical models to understand their capability to terminate paroxysmal AF. The project expects to provide consistent, reliable and reproducible parameters that will assist clinicians to know what type of paroxysmal AF episodes will be more suitable to effectively terminate, upon administration of drugs with an atrial specific and atria-preferential profile.

Start Date01 Jan 2017

Sponsor / Collaborator-

100 Clinical Results associated with Vernakalant Hydrochloride

100 Translational Medicine associated with Vernakalant Hydrochloride

100 Patents (Medical) associated with Vernakalant Hydrochloride

280

Literatures (Medical) associated with Vernakalant Hydrochloride

01 Aug 2024·CLINICAL CARDIOLOGY

Effect of Obesity on the Use of Antiarrhythmics in Adults With Atrial Fibrillation: A Narrative Review

Review

Author: Castelino, Ronald L. ; Ferguson, Caleb ; Inglis, Sally C. ; Shaikh, Fahad ; Wynne, Rochelle ; Davidson, Patricia M.

ABSTRACT:

Background:

Atrial fibrillation (AF) and obesity coexist in approximately 37.6 million and 650 million people globally, respectively. The anatomical and physiological changes in individuals with obesity may influence the pharmacokinetic properties of drugs.

Aim:

This review aimed to describe the evidence of the effect of obesity on the pharmacokinetics of antiarrhythmics in people with AF.

Methods:

Three databases were searched from inception to June 2023. Original studies that addressed the use of antiarrhythmics in adults with AF and concomitant obesity were included.

Results:

A total of 4549 de‐duplicated articles were screened, and 114 articles underwent full‐text review. Ten studies were included in this narrative synthesis: seven cohort studies, two pharmacokinetic studies, and a single case report. Samples ranged from 1 to 371 participants, predominately males (41%–85%), aged 59–75 years, with a body mass index (BMI) of 23–66 kg/m2. The two most frequently investigated antiarrhythmics were amiodarone and dofetilide. Other drugs investigated included diltiazem, flecainide, disopyramide, propafenone, dronedarone, sotalol, vernakalant, and ibutilide. Findings indicate that obesity may affect the pharmacokinetics of amiodarone and sodium channel blockers (e.g., flecainide, disopyramide, and propafenone). Factors such as drug lipophilicity may also influence the pharmacokinetics of the drug and the need for dose modification.

Discussion:

Antiarrhythmics are not uniformly affected by obesity. This observation is based on heterogeneous studies of participants with an average BMI and poorly controlled confounding factors such as multimorbidity, concomitant medications, varying routes of administration, and assessment of obesity. Controlled trials with stratification at the time of recruitment for obesity are necessary to determine the significance of these findings.

01 Jul 2024·EBioMedicine

Advancing drug development for atrial fibrillation by prioritising findings from human genetic association studies

Article

Author: Providencia, Rui ; Lambiase, Pier D ; Finan, Chris ; Schilling, Richard ; Floriaan Schmidt, Amand ; Kukendrarajah, Kishore ; Farmaki, Aliki-Eleni

BACKGROUND:

Drug development for atrial fibrillation (AF) has failed to yield new approved compounds. We sought to identify and prioritise potential druggable targets with support from human genetics, by integrating the available evidence with bioinformatics sources relevant for AF drug development.

METHODS:

Genetic hits for AF and related traits were identified through structured search of MEDLINE. Genes derived from each paper were cross-referenced with the OpenTargets platform for drug interactions. Confirmation/validation was demonstrated through structured searches and review of evidence on MEDLINE and ClinialTrials.gov for each drug and its association with AF.

FINDINGS:

613 unique drugs were identified, with 21 already included in AF Guidelines. Cardiovascular drugs from classes not currently used for AF (e.g. ranolazine and carperitide) and anti-inflammatory drugs (e.g. dexamethasone and mehylprednisolone) had evidence of potential benefit. Further targets were considered druggable but remain open for drug development.

INTERPRETATION:

Our systematic approach, combining evidence from different bioinformatics platforms, identified drug repurposing opportunities and druggable targets for AF.

FUNDING:

KK is supported by Barts Charity grant G-002089 and is mentored on the AFGen 2023-24 Fellowship funded by the AFGen NIH/NHLBI grant R01HL092577. RP is supported by the UCL BHF Research Accelerator AA/18/6/34223 and NIHR grant NIHR129463. AFS is supported by the BHF grants PG/18/5033837, PG/22/10989 and UCL BHF Accelerator AA/18/6/34223 as well as the UK Research and Innovation (UKRI) under the UK government's Horizon Europe funding guarantee EP/Z000211/1 and by the UKRI-NIHR grant MR/V033867/1 for the Multimorbidity Mechanism and Therapeutics Research Collaboration. AF is supported by UCL BHF Accelerator AA/18/6/34223. CF is supported by UCL BHF Accelerator AA/18/6/34223.

01 Jul 2024·JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Chamber-specific contractile responses of atrial and ventricular hiPSC-cardiomyocytes to GPCR and ion channel targeting compounds: A microphysiological system for cardiac drug development

Article

Author: Turner, Jan ; Stoelzle-Feix, Sonja ; Dragicevic, Elena ; Lotay, Hardeep ; Thomas, Ulrich ; Gossmann, Matthias ; Broadbent, Steven ; Linder, Peter ; Hunker, Jan ; Lickiss, Bettina ; Bhagwan, Jamie

Human induced pluripotent stem cell (hiPSC)-derived cardiomyocytes (CMs) have found utility for conducting in vitro drug screening and disease modelling to gain crucial insights into pharmacology or disease phenotype. However, diseases such as atrial fibrillation, affecting >33 M people worldwide, demonstrate the need for cardiac subtype-specific cells. Here, we sought to investigate the base characteristics and pharmacological differences between commercially available chamber-specific atrial or ventricular hiPSC-CMs seeded onto ultra-thin, flexible PDMS membranes to simultaneously measure contractility in a 96 multi-well format. We investigated the effects of GPCR agonists (acetylcholine and carbachol), a Ca²⁺ channel agonist (S-Bay K8644), an HCN channel antagonist (ivabradine) and K⁺ channel antagonists (4-AP and vernakalant). We observed differential effects between atrial and ventricular hiPSC-CMs on contractile properties including beat rate, beat duration, contractile force and evidence of arrhythmias at a range of concentrations. As an excerpt of the compound analysis, S-Bay K8644 treatment showed an induced concentration-dependent transient increase in beat duration of atrial hiPSC-CMs, whereas ventricular cells showed a physiological increase in beat rate over time. Carbachol treatment produced marked effects on atrial cells, such as increased beat duration alongside a decrease in beat rate over time, but only minimal effects on ventricular cardiomyocytes. In the context of this chamber-specific pharmacology, we not only add to contractile characterization of hiPSC-CMs but propose a multi-well platform for medium-throughput early compound screening. Overall, these insights illustrate the key pharmacological differences between chamber-specific cardiomyocytes and their application on a multi-well contractility platform to gain insights for in vitro cardiac liability studies and disease modelling.

News (Medical) associated with Vernakalant Hydrochloride

29 Aug 2022

·www.biospace.com

Hypertrophic Cardiomyopathy Therapeutics Market is Expected To Reach USD 1.42 Billion By 2027 at a CAGR of 2.1%

According to the current analysis of Reports and Data, the global Hypertrophic Cardiomyopathy Therapeutics Market valued at USD 1.20 Billion in 2019 and is expected to reach USD 1.42 billion by the year 2027, at a CAGR of 2.1%. Hypertrophic cardiomyopathy (HCM) alters the functioning of the heart. Increasing prevalence of cardiovascular disorders, lifestyle habits like smoking and consumption of alcohol, obesity, and growth in the geriatric populations are the factors driving the growth of the market. However, the high-cost expenditure of treatment is restraining the market. According to the report, the World Health Organization (WHO) estimated that 17.9 million people died from cardiovascular diseases in the year 2016, which includes approximately 31% of all global deaths. According to the WHO, in 2016, more than 1.9 billion adults aged 18 years and older were overweight. Regionally, in Africa, the number of overweight children under five has increased by nearly 50% since 2000. Approximately half of the children under five who were overweight or obese in 2018 lived in Asia. The prevalence of obesity among children and adolescents aged 5-19 has risen dramatically. According to Canadian Community Health Survey, in 2018, nearly 63.1% of Canadian adults were either obese or overweight, in which approximately 26.8%, i.e., 7.3 million adults, were obese and another 9.9 million, i.e., 36.3% of Canadian adults were overweight. In 2019 approximately 35% of Americans were obese or overweight in the United States. Access Free sample PDF Copy of the Report (To Understand the Complete Structure of this Report [Summary + TOC]) @ Asia Pacific region is likely to increase the market growth due to factors like an increase in the patient population, lifestyle habits like smoking and consumption of alcohol and, rise in the geriatric population, etc. Further key findings from the report suggest In the year 2019, Correvio Pharma had resubmitted the New Drug Application (NDA) for Brinavess (vernakalant hydrochloride) for the treatment of cardiac arrhythmias to the Food and Drug Administration. But the FDA issued a CRL letter to Correvio Pharma and rejected Brinavess (vernakalant hydrochloride) as it was seen that the drug had prolonged atrial refractoriness and slowed the impulse conduction in a rate-dependent fashion, but the data provided in the application did not provide reassurance of the safety. The NYIT College of Osteopathic Medicine (NYITCOM) researchers, offered a new treatment for patients with beta-blocker intolerance, here T3 (thyroid hormone therapy) was used in the treatment. It is an effective method for managing cardiovascular disorders, and showed better contraction and relaxation of the heart, and was found to be a better treatment for patients. Strokes are one of the causes of hypertrophic cardiomyopathy. In February 2020, the FDA had approved a clinical trial that on Abbott's Amplatzer Amulet, a stroke prevention device it was found to be more beneficial than the new class of blood thinners that are currently used in the treatment. It involves a minimally invasive procedure used for patients with atrial fibrillation. It is an effective non-prescription drug alternative for patients with arterial fibrillation who are at an increased risk for ischemic stroke. Medtronicin January 2020, had announced that it had received the CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D).ICDs are used to monitor heart rhythms and supply proper therapy to correct heart rates that are too fast that lead to sudden cardiac arrest. CRT-Ds is a treatment option for some individuals with heart failure; it sends small electrical impulses to the lower chambers of the heart to support them beat in more synchronized patterns and to reduce arrhythmia symptoms. Merck in the year 2019 announced an acquisition of ArQule for arround USD 2.7 billion. This acquisition had strengthened Merck's pipeline it and also included ARQ 531 for the treatment of B-cell malignancies. By Drugs segment, the antiarrhythmic drugs have obtained the largest share of about 36.4% in the year 2019, due to the rise in the incidences of cardiac arrhythmias and also due to the lifestyle factors like smoking and consumption of alcohol On the basis of devices defibrillators accounted for USD 598.3 million for the year 2019. The ongoing pandemic is significantly changing the dynamics of the pharma and healthcare sector. Various countries are facing challenges such as shortage of medicines, vaccines, healthcare devices in hospitals. This is expected to open lucrative growth opportunities for market players in the coming years. For Inquiry Before Buying @ Competitive Landscape: The global market comprises various market players operating at regional and global levels. These key players are adopting various strategies such as R&D investments, license agreements, partnerships, merger and acquisitions, collaborations, and joint ventures to gain robust footing in the market. Top Companies Profiled in the Report: AstraZeneca, Merck, Pfizer, Sanofi, Gilead Sciences, Novartis, Teva Pharmaceutical, Correvio Pharma Industries, Abbot, Lupin limited Browse Full Report Description with Research Methodology, Table of Content and Infographics @ Hypertrophic Cardiomyopathy Therapeutics Market Segmentation: Drugs Outlook (Revenue in Million USD; (2017–2027) Antiarrhythmic Agents Anticoagulants Beta-Adrenergic Blocking Agents Calcium Channel Blockers Others Devices Outlook (Revenue in Million USD; (2017–2027) Defibrillators Pacemakers Other Medical Devices End Use Outlook (Revenue in Million USD; (2017–2027) Hospitals Clinics Others Regional Outlook: North America (U.S., Canada, Mexico) Europe (Germany, U.K., Italy, France, BENELUX, Rest of Europe) Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific) Latin America (Brazil, Rest of LATAM) Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa) Ask for Customize Research Report @ This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth. Explore More Industry Research by Reports and Data: Aesthetic Medicine Market Size, Share, Trends, By Product (Energy-Based Devices, Implants, Anti-Wrinkle Products), By Application (Surgical, Non-Surgical), End-use (Medical Spas and Beauty Centers), and By Region Forecast to 2030 Download PDF Brochure Surgical Glue Market, By Product Type (Synthetic and Semi-Synthetic, Natural), By Application (Cardiovascular Surgery, Pulmonary Surgery, Others), By End-use (Hospitals, Ambulatory Surgical Centers, Others), and By Region Forecast to 2030 Download PDF Brochure Hernia Mesh Market By Hernia Type (Inguinal Hernia, Incisional Hernia, Femoral Hernia, and Others), By Mesh Type, By Synthetic Structure Type, By Synthetic Product Type, and By End Users And Segment Forecasts, 2020-2028 Download PDF Brochure Anxiety Disorder and Depression Treatment Market By Therapies (Cognitive Behavior Therapy (CBT)), By Drug Class (Antidepressant Drugs, Selective Serotonin Reuptake Inhibitors (SSRIs)), By Devices, By Application, and End-users, And Segment Forecasts To 2028 Download PDF Brochure About Reports and Data Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyze consumer behavior shifts across demographics, across industries, and help clients to make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Products, and Energy. We consistently update our research offerings to ensure our clients are aware of the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise. Our industry experience and ability to develop a concrete solution to any research problems provides our clients with the ability to secure an edge over their respective competitors. Contact Us: John W Head of Business Development Reports And Data | Web: Direct Line: +1-212-710-1370 E-mail: sales@reportsanddata.com LinkedIn | Twitter | Blogs Read the innovative blog at Check out our upcoming research report at For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update:

VaccineAcquisitionCollaborate

13 Dec 2019

·www.biospace.com

FDA Action Alert: Correvio, Intra-Cellular and Amarin

The U.S. Food and Drug Administration is wrapping up 2019 with a few PDUFA dates. Here’s a look. The U.S. Food and Drug Administration (FDA) is wrapping up 2019 with a few PDUFA dates. Here’s a look. Correvio Pharma’s Brinavess for Atrial Afibrillation Correvio Pharma Corp., based in Vancouver, British Columbia, has a target action date of December 24, 2019 for its resubmitted New Drug Application (NDA) for Brinavess (vernakalant hydrochloride, IV). This is an antiarrhythmia drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. The NDA was built on data from SPECTRUM, a post-authorization safety study conducted in Europe of 1,778 unique patients across a total of 2,009 treatment episodes after dosing of Brinavess. The data showed that Brinavess successfully converted 70.2% of the treated AF patients into normal sinus rhythm. It also demonstrated a median time to conversion of 11 minutes from the start of the first infusion in the patients who were successfully converted. Brinavess is already approved for marketing in Europe, Canada and several other countries. It is approved in the EU for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients who had AF less than 7 days duration, for post-cardiac surgery patients with AF less than 3 days duration. It is not yet approved in the U.S. On December 10, an FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does. hbspt.cta.load(4413123, '4e87abe9-779b-4c65-98dd-ea451779faa9', {}); Intra-Cellular Therapies’ Lumateperone for Schizophrenia New York-based Intra-Cellular Therapies has a target action date of December 27 for its NDA for lumateperone for schizophrenia. This is actually three months after the initial PDUFA date after a planned submission of non-clinical data was viewed to be a major amendment to the NDA. The data was generated from toxicology data in animal studies. The company indicates that the metabolic pathway involved and the metabolites formed, are different in humans and animals and as a result, the animal findings are not relevant to humans. Lumateperone selectively and simultaneously modulates serotonin, dopamine, and glutamate, three neurotransmitter pathways implicated in severe mental illness. It is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate, and a serotonin reuptake inhibitor. Amarin’s Vascepa For Reducing Heart Attack and Stroke Risk Vascepa Corporation has a target action date of December 28 for its fish oil-based drug Vascepa (icosapent ethyl) for its supplemental NDA (sNDA) related to the REDUCE-IT cardiovascular outcomes trial. Currently, Vascepa is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia. On November 14, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously 16 to 0 to recommend approval of the drug for the indication and label expansion to reduce the risk of cardiovascular events in high-risk patients. This recommendation was based on results from the REDUCE-IT cardiovascular outcomes trial. The agency is not required to go along with adcom recommendations, although they often do—particularly when they’re unanimous. REDUCE-IT was a global CV outcomes trial that prospectively evaluated the effect of the drug in adults with LDL-C levels between 41 and 100 mg/dL that were controlled by statins and had various CV risk factors such as persistent elevated TG between 135-499 mg/dL and either established CV disease or diabetes, and at least one other CV risk factor. The trial ran for seven years and was completed in 2018. It tracked 8,179 patients at 400 clinical sites in 11 countries. The results were published in the journal Clinical Cardiology in March 2018 and subsequently the primary results were published in The New England Journal of Medicine in November 2018. hbspt.forms.create({ portalId: "4413123", formId: "c4dda430-e2b0-4083-86f3-ccce0c1d4479" });

NDADrug Approval

12 Dec 2019

·www.biospace.com

Correvio Pharma Considering Sale Amid FDA Headwinds on Cardiovascular Drug

The FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does. Correvio Pharma Corp., based in Vancouver, British Columbia, indicated that it is considering a sale after a U.S. Food and Drug Administration (FDA) advisory committee voted against approving its Brinavess (vernakalant hydrochloride, IV). This is an antiarrhythmia drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. Brinavess is already approved for marketing in Europe, Canada and several other countries. It is approved in the EU for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients who had AF less than 7 days duration, for post-cardiac surgery patients with AF less than 3 days duration. It is not yet approved in the U.S. Correvio has a target action date of December 24, 2019 for its resubmitted New Drug Application (NDA) for Brinavess. However, the FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does. The NDA was built on data from SPECTRUM, a post-authorization safety study conducted in Europe of 1,778 unique patients across a total of 2,009 treatment episodes after dosing of Brinavess. The data showed that Brinavess successfully converted 70.2% of the treated AF patients into normal sinus rhythm. It also demonstrated a median time to conversion of 11 minutes from the start of the first infusion in the patients who were successfully converted. “Given yesterday’s FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting outcome for Brinavess (vernakalant IV) for the conversion of atrial fibrillation (AF), we believe it is in the best interest of our stakeholders to expand our internal corporate development efforts and formally evaluate strategic alternatives for the company,” said Mark H.N. Corrigan, Correvio’s chief executive officer. Corrigan added, “We have a strong and growing commercial portfolio of assets being sold across the globe and we will immediately begin preparations for a potential strategic transaction while we await the U.S. Food and Drug Administration (FDA)’s decision regarding Brinavess. We are also taking steps to reduce operating costs outside the core European commercial business and a transaction committee has been formed within the Board of Directors.” The adcom’s vote was an indication they did not believe the benefit-risk pro the drug was enough to support approval. The company’s commercial portfolio outside the U.S. is expected to bring in about $30 million in revenue this year. That portfolio is made up of four approved and commercialized branded products and one product candidate. They are Xydalba (dalbavancin hydrochloride) for acute bacterial skin and skin structure infections; Zevtera/Mabelio (ceftobiprole medocaril sodium), an antibiotic for community- and hospital-acquired pneumonia; Brinavess; Aggrastat (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome; and Trevyent, a drive device combination that delivers treprostinil, a treatment for pulmonary arterial hypertension. Correvio has hired Piper Jaffray to help review its strategic options. Without indicating whether it expected job cuts, the company stated it planned to reduce its operating costs in North America. This way it would focus its resources on essential commercial and business development activities. Correvio has made attempts to get approval for Brinavess in the U.S. since 2006. The FDA has never approved it because of safety concerns. At one point the U.S. trials were placed on hold after the death of a patient. The clinical hold is still in place. In a 2014 research and review paper in Current Cardiology Reviews , John Camm, with St. George’s University of London, UK, wrote, “The terms of the [European] approval are very strictly aligned to the evidence base for vernakalant. … Regulators were able to label the drug to avoid the majority of other adverse effects of vernakalant offered an alternative to amiodarone in patients with mild or moderate heart disease. Although amiodarone achieves conversion in a high proportion of patients its action is relatively delayed. A clear unmet need could potentially be filled by this new antiarrhythmic drug.” Although the paper is five years old, Camm’s conclusion likely holds today: “The difference between regulatory opinions on both sides of the Atlantic is disturbing and perplexing. Agencies in Europe and the USA came to different conclusions when examining the same evidence-base. Thus, neither opinion can be entirely or easily accepted.”

Drug ApprovalNDA

100 Deals associated with Vernakalant Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D06665	Vernakalant Hydrochloride	C01BG11	DB06217

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Atrial Fibrillation	European Union	Advanz Pharma Corp. Ltd.	01 Sep 2010
Atrial Fibrillation	Iceland	Advanz Pharma Corp. Ltd.	01 Sep 2010
Atrial Fibrillation	Liechtenstein	Advanz Pharma Corp. Ltd.	01 Sep 2010
Atrial Fibrillation	Norway	Advanz Pharma Corp. Ltd.	01 Sep 2010
Arrhythmias, Cardiac	Canada	Cardiome UK Ltd.	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Atrial arrhythmia	Phase 3	United States	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	United States	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	Argentina	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	Argentina	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	Canada	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	Canada	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	Denmark	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	Denmark	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	India	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	India	Advanz Pharma Corp. Ltd.	01 Jun 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SPECTRUM (ESC2019)	Not Applicable	Atrial fibrillation new onset	-	Vernakalant	xzstbxzrre(xdspqtlvag) = rolmdwbesr dbqizvpuwb (ptsltsevut, 68.1–72.2) View more	-	02 Sep 2019
NCT01174160 (Pubmed \| Am J Cardiol) Manual	Phase 3	Atrial Fibrillation	111	Vernakalant	vromilqmpv(qfyhleenoe) = uqtafnsuon vaagrqulza (yapgbqmhiz )	Positive	01 Feb 2017
				Placebo	vromilqmpv(qfyhleenoe) = grrfdthvgz vaagrqulza (yapgbqmhiz )
NCT01447862 (Pubmed \| Europace)	Phase 4	Atrial Fibrillation	100	Vernakalant	veadgwebxj(dpreyhroea) = ivtfgoddbx csiitwogat (yzfmnokpmn ) View more	Positive	01 Feb 2017
				Ibutilide	veadgwebxj(dpreyhroea) = affhhnhtay csiitwogat (yzfmnokpmn ) View more
NCT00989001 (ACT V, Pubmed \| BMC Cardiovasc Disord) Manual	Phase 3	Atrial Fibrillation	217	vernakalant	goscfufvxp(mubddvyaal) = yjtrxacpfs bbinyfmwwu (jkgfaashbq )	Positive	28 May 2016
				Placebo	goscfufvxp(mubddvyaal) = gcokkjorak bbinyfmwwu (jkgfaashbq )
NCT01174160 (CTgov)	Phase 3	Atrial Fibrillation	123	Placebo to vernakalent hydrochloride	lsfnjlnble = zugucqozhy dbcfjgpnrl (spwxhllewh, dtfphsusie - oumjuaruhr) View more	-	15 Dec 2015
NCT00476112 (Pubmed \| Europace)	Phase 2/3	Atrial Flutter	60	Vernakalant	fdkzbjubgc(fhhvejqaos) = dtmmfsocgn mkzpkrxjvn (iyytdoprry )	Negative	01 Jun 2012
NCT00668759 (AVRO, Pubmed \| J Am Coll Cardiol)	Phase 3	Atrial Fibrillation	254	Vernakalant	yedzgbclhz(eviwjpeihb) = avsedhzedw tsctpygecw (zkvoetkqbg )	Positive	18 Jan 2011
				Amiodarone	yedzgbclhz(eviwjpeihb) = mxuvoaettx tsctpygecw (zkvoetkqbg )
NCT00281554 \| NCT00468767 (ACT I and ACT IV, Pubmed \| Acad Emerg Med)	Phase 3	Atrial Fibrillation	290	Vernakalant	qzjmhvmlxs(escuwicjuc) = hmsaikaqli iekdbiixkx (aomxmjrvas )	Positive	01 Nov 2010

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Vernakalant Hydrochloride

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