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.

Advanz Pharma Switzerland SARLMerck Sharp & Dohme BV

+ [6]

Inactive Organization

Astellas Pharma, Inc.

Advanz Pharma Corp. Ltd.ATCO Corp.

Drug Highest PhaseApproved

First Approval Date

EU (01 Sep 2010),

Atrial Fibrillation

RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN)

Structure

Molecular FormulaC20H32ClNO4

InChIKeyJMHYCBFEEFHTMK-IIUXMCBISA-N

CAS Registry748810-28-8

Clinical Trials associated with Vernakalant Hydrochloride

NCT04748991 / Not yet recruitingPhase 3

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 / RecruitingPhase 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 4IIT

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

Hospital San Carlos, Madrid

100 Clinical Results associated with Vernakalant Hydrochloride

100 Translational Medicine associated with Vernakalant Hydrochloride

100 Patents (Medical) associated with Vernakalant Hydrochloride

237

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·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 ; Hunker, Jan ; Linder, Peter ; 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.

19 Apr 2024·Cureus Journal of Medical Science

Efficacy and Safety of Intravenous Vernakalant in Rapid Cardioversion of Recent Onset Atrial Fibrillation: A Retrospective Single-Centre Study

Article

Author: Abi-Saleh, Bernard ; Hoteit, Abbas ; Nahlawi, Acile ; Refaat, Marwan ; Abdulhai, Farah ; Hebbo, Elsa ; Khoury, Maurice ; Moumneh, Mohamad B.

BACKGROUND:

We use vernakalant, an intravenous anti-arrhythmic, to cardiovert paroxysmal atrial fibrillation (AF) into sinus rhythm. It is a relatively atrium-selective, early-activating potassium and frequency-dependent sodium channel blocker with a half-life of 2 to 3 hours. Due to concerns regarding its safety profile, it is not Food and Drug Administration (FDA)-approved.

OBJECTIVE:

This study aims to assess the efficacy of intravenous vernakalant in cardioversion of paroxysmal AF and the safety of its use.

METHODS:

Patients with paroxysmal AF who presented to the American University of Beirut Medical Center (AUBMC) between 2015 and 2020 and received vernakalant for cardioversion were included. Patients did not receive vernakalant if they had any of the following: QTc > 440 ms, heart rate < 50 bpm, acute coronary syndrome within the last 30 days, second- and third-degree atrioventricular (AV) block in the absence of a pacemaker, severe aortic stenosis (AS), use of intravenous antiarrhythmics (class I and class III) within four hours of vernakalant infusion, systolic blood pressure <100 mmHg, and heart failure (New York Heart Association (NYHA) III or NYHA IV class). The primary endpoint is conversion to sinus rhythm for at least one minute within 90 minutes of the start of the vernakalant infusion. The secondary endpoint included the presence of these side effects: bradycardia, QTc prolongation, AV block, ventricular arrhythmias, hypotension, taste alteration/dysgeusia, sneezing, nausea, vomiting, paresthesia, cardiogenic shock, or death.

RESULTS:

The study included 23 patients with paroxysmal AF (15 men, mean age 54 ± 14 years). Fourteen patients (61%) cardioverted to sinus rhythm within 90 minutes of the start of the Vernakalant infusion. Seven patients (30%) reverted to sinus rhythm within 15 minutes after the first infusion. After treatment with vernakalant, four patients (17%) developed sinus bradycardia, and four patients (17%) developed first-degree AV block. No patient had a QTc greater than 460 ms. None of the patients experienced sinus pauses, high-grade AV block, ventricular arrhythmias, hypotension, dysgeusia, sneezing, nausea, vomiting, paresthesia, cardiogenic shock, or death.

CONCLUSION:

Vernakalant had 61% efficacy in the rapid cardioversion of paroxysmal AF to sinus rhythm, was well tolerated, and had a low rate of adverse events in our study population.

News (Medical) associated with Vernakalant Hydrochloride

29 Aug 2022

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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. 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02 Sep 2010

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Cardiome Pharma Corp. Gets Nod For Marketing Heart Drug In EU; Receives $30 Million From Merck Sharp & Dohme

VANCOUVER, Sept. 2 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ:CRME - News) today announced that it has earned a US$30 million milestone payment from its collaboration with Merck (known as MSD outside the United States and Canada), through an affiliate. The milestone was triggered by the recently announced marketing approval for BRINAVESS(TM) (vernakalant (iv)) in the European Union, Iceland and Norway. "European approval and the milestone payment further strengthen Cardiome's financial position, both in the near term and in the long term via royalties from product sales," said Doug Janzen, Chief Executive Officer and President of Cardiome. "The teams at Merck and Cardiome have done an exemplary job in gaining European regulatory approval for BRINAVESS, and Cardiome is now part of a select group of biotechnology companies who have successfully shepherded a molecule from discovery through to product approval." Merck Cardiome Agreement In April 2009, Cardiome and Merck announced a collaboration and license agreement for the development and commercialization of vernakalant. The agreement provides Merck, Sharp and Dohme Corp. (formerly known as Merck & Co., Inc.) with exclusive global rights to vernakalant oral formulation for the maintenance of normal heart rhythm in patients with atrial fibrillation (AF), and provides another Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to vernakalant IV formulation for rapid conversion of recent onset AF to sinus rhythm in adults. About Cardiome Pharma Corp. Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Cardiome is traded on the NASDAQ Global Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at Forward-Looking Statement Disclaimer Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements regarding product revenues following Merck's expected launch of BRINAVESS and other statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Risks, uncertainties and factors that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks, uncertainties and factors related to the fact that: we, together with our collaborative partners, may not be able to successfully develop all or any of our current or future products and may not be able to obtain regulatory approval in targeted indications for our current or future products in all markets; we may not achieve or maintain profitability; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital as and when required; we depend on our collaborative partners to perform their obligations under licensing or other collaborative agreements; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; any of our products that obtain regulatory approval will be subject to extensive post-market regulation that may effect sales, marketing and profitability; any of our products that are successfully developed may not achieve market acceptance; we rely on third parties for the continued supply and manufacture of our products and have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters, including with respect to our ability to protect our intellectual property; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Securities and Exchange Commission available at and the Canadian securities regulatory authorities at Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

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06 Nov 2007

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Cardiome Pharma Corp. to Present at CIBC Conference

VANCOUVER, Nov. 5 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. today announced that Bob Rieder, Chairman and Chief Executive Officer, will present an overview of Cardiome at the CIBC World Markets Annual Healthcare Conference in New York at 1:20pm Eastern Time (10:20am Pacific Time) on Tuesday, November 6, 2007. A live webcast of Mr. Rieder's presentation can be accessed on Cardiome's website at A replay of the webcast will be posted after the presentation and will be available until December 6, 2007. About Cardiome Pharma Corp. Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, an engineered analog of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function. Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006. Positive top-line results from an additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007. An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed. Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for vernakalant (oral) in September 2006. A Phase 2b study for vernakalant (oral) is ongoing. In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack. Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Forward-Looking Statement Disclaimer Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Securities and Exchange Commission available at and the Canadian securities regulatory authorities at Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law. CONTACT: Peter K. Hofman, Senior Director, Investor Relations, (604) 676-6993, or Toll Free: 1-800-330-9928, Email: phofman@cardiome.com CONTACT: Peter K. Hofman, Senior Director, Investor Relations, (604) 676-6993, or Toll Free: 1-800-330-9928, Email: phofman@cardiome.com

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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	EU	Advanz Pharma Switzerland SARL	01 Sep 2010
Atrial Fibrillation	IS	Advanz Pharma Switzerland SARL	01 Sep 2010
Atrial Fibrillation	LI	Advanz Pharma Switzerland SARL	01 Sep 2010
Atrial Fibrillation	NO	Advanz Pharma Switzerland SARL	01 Sep 2010
Arrhythmias, Cardiac	CA	Cardiome UK Ltd.	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Atrial arrhythmia	Phase 3	US	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	US	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	AR	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	AR	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	CA	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	CA	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	DK	Advanz Pharma Corp. Ltd.	01 Jun 2004
Atrial arrhythmia	Phase 3	DK	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	IN	Astellas Pharma, Inc.	01 Jun 2004
Atrial arrhythmia	Phase 3	IN	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	wdwkauwwqf(avzhbwfena) = ukwvflwxum hutgveqvvx (yzclmaerjp, 68.1–72.2) View more	-	02 Sep 2019
NCT01174160 (Pubmed \| Am J Cardiol) Manual	Phase 3	Atrial Fibrillation	111	Vernakalant	tmlrqpctvv(ovudnkyjsb) = vxdcrcmzvn ghiacfedju (sanivkmnit )	Positive	01 Feb 2017
				Placebo	tmlrqpctvv(ovudnkyjsb) = juqikjadrf ghiacfedju (sanivkmnit )
NCT01447862 (Pubmed \| Europace)	Phase 4	Atrial Fibrillation	100	Vernakalant	mrrjmqftau(nwnxhhmduu) = icaxtwcrtq ozcbohyktz (xatrysgtym ) View more	Positive	01 Feb 2017
				Ibutilide	mrrjmqftau(nwnxhhmduu) = etarlskytd ozcbohyktz (xatrysgtym ) View more
NCT00989001 (ACT V, Pubmed \| BMC Cardiovasc Disord) Manual	Phase 3	Atrial Fibrillation	217	vernakalant	mxmlelphyf(zzcqmbvzbf) = yvmjfvstie rnxxtewpax (rerxbkpsjb )	Positive	28 May 2016
				Placebo	mxmlelphyf(zzcqmbvzbf) = ktdskmmisa rnxxtewpax (rerxbkpsjb )
NCT01174160 (CTgov)	Phase 3	Atrial Fibrillation	123	Placebo to vernakalent hydrochloride	pcycgqhiap(ogcfyorebz) = ezmvfiashk fwtebtdgnd (rlmsbdtxxt, sozkzidtcd - sdmruapaip) View more	-	15 Dec 2015
NCT00476112 (Pubmed \| Europace)	Phase 2/3	Atrial Flutter	60	Vernakalant	kknfyulrmr(pmjlndlwcj) = bhatcnbrnk mrkifpuazo (ahfbiqlfby )	Negative	01 Jun 2012
NCT00668759 (AVRO, Pubmed \| J Am Coll Cardiol)	Phase 3	Atrial Fibrillation	254	Vernakalant	fryntguawq(vnbkqscjvp) = zplhitfwef lyodxtidfi (brojjurdit )	Positive	18 Jan 2011
				Amiodarone	fryntguawq(vnbkqscjvp) = unykoqbimc lyodxtidfi (brojjurdit )
NCT00281554 \| NCT00468767 (ACT I and ACT IV, Pubmed \| Acad Emerg Med)	Phase 3	Atrial Fibrillation	290	Vernakalant	sufmxzwryf(gwqnasjmnz) = ziinltblnb nfhmsoujkn (sblycbljnw )	Positive	01 Nov 2010

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