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Brinavess Approval Status

FDA Approved: No
Brand name: Brinavess
Generic name: vernakalant
Dosage form: Intravenous Injection
Previous Name: Kynapid
Company: Cardiome Pharma Corp.
Treatment for: Atrial Fibrillation

Brinavess (vernakalant) is an investigational antiarrhythmic drug in development for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).

Development Status and FDA Approval Process for Brinavess

DateArticle
Jun 24, 2019Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation
Aug 21, 2017Cardiome Provides U.S. Regulatory Update for Brinavess
May  2, 2013Cardiome Accepts the Transfer of Sponsorship of U.S. and Canadian Vernakalant IV and Oral Regulatory Filings from Merck
Dec 29, 2010Cardiome Provides Update for Oral Vernakalant Development Program
May 14, 2010Merck and Cardiome Announce Phase III Study Results Comparing Investigational Compound Brinavess (Vernakalant) Intravenous to Amiodarone Injection in Conversion of Atrial Fibrillation to Normal Sinus Rhythm
Dec 18, 2009Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study
Aug 28, 2009Cardiome Announces Upcoming Presentation Of Results Of Phase 2b Clinical Trial Of Vernakalant (Oral) At The European Society Of Cardiology Congress 2009
Aug 12, 2009Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement
Oct  9, 2008Cardiome Provides Kynapid Regulatory Update
Aug 11, 2008Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid
Jul 15, 2008Cardiome Announces Positive Phase 2b Results For Oral Vernakalant
Jul 14, 2008Cardiome Announces Positive Phase 2b Results For Oral Vernakalant
Mar 25, 2008Circulation Publishes Data Showing Kynapid (VernakalantHydrochloride) Injection Rapidly Converted Short-Duration AtrialFibrillation to Sinus Rhythm
Mar 17, 2008Cardiome Announces Positive Interim Phase 2b Results for OralVernakalant and Engages Merrill Lynch as Strategic Advisor
Jan 22, 2008Cardiome And Astellas Announce Kynapid Regulatory Update
Dec 12, 2007FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation
Nov  7, 2007Study Shows Vernakalant Hydrochloride is Effective in Conversion toNormal Heart Rhythm in Atrial Fibrillation Patients FollowingCardiac Surgery
Oct 10, 2007Analysis Shows Vernakalant Hydrochloride Injection IncreasesConversion to Normal Heart Rhythm in Acute Atrial FibrillationPatients Treated Within 48 Hours of Onset
Aug 30, 2007Cardiome And Astellas Announce Regulatory Extension
Feb 19, 2007Cardiome And Astellas Announce Acceptance Of NDA For Review
Dec 18, 2006Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
May 31, 2006Cardiome Announces Refusal to File Decision By the FDA
Mar 31, 2006New Drug Application Submitted For RSD1235

Further information

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