Cipher Pharmaceuticals has announced the Canadian launch of Brinavess (vernakalant hydrochloride) for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm (SR) for non-surgery patients with duration of AF less than seven days and post-cardiac surgery patients with duration of AF less than three days.
AF affects approximately 350,000 patients in Canada.
St. Michael’s Hospital staff cardiac electrophysiologist and University of Toronto cardiology division department director Dr Paul Dorian said: “Brinavess offers an important safe and effective option for the treatment of recent onset atrial fibrillation.
“In Phase III trials, Brinavess demonstrated a median time to cardioversion of 11 minutes in 51% of the treated AF patients and 97% of these treated patients maintained SR at 24 hours post treatment.”
In post-cardiac surgery settings, 47% patients cardioverted at a median time of 12 minutes when treated with Brinavess vs 14% patients in the placebo group (p<0.0001).
In a head-to-head comparison study, treatment with Brinavess converted approximately 51% of treated patients to sinus rhythm, versus 5.2% of patients treated with amiodarone, resulting in a significantly higher conversion rate for Brinavess vs amiodarone treated patients at the 90 minute timepoint (p<0.0001).
Cipher president and CEO Robert Tessarolo said: “We are excited to bring this safe and effective treatment to Canadians who are suffering from acute onset atrial fibrillation.
“Brinavess has demonstrated fast and sustained cardioversion to sinus rhythm which has been shown to reduce the length of stay in the emergency department which is critical for patient care in an acute hospital setting.
“Brinavess is Cipher’s second product launch this year and seventh marketed product in Canada. We are committed to further expanding our Canadian business with future product launches and by continuing to assemble a broad portfolio of prescription products that serve unmet medical needs.”
Cipher acquired Brinavess through the acquisition of the Canadian business portfolio of Cardiome Pharma Corp., which was completed in May 2018.
Atrial Fibrillation (“AF”) is a supraventricular tachyarrhythmia with uncoordinated atrial activation resulting in ineffective atrial contraction and, if left untreated, structural and/or electrophysiological atrial tissue abnormalities.
AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age. 2 Patients with AF may present with a variety of symptoms including palpitations, chest pain, shortness of breath, fatigue and light headedness. These symptoms alone can have a considerable impact on the patient’s quality of life.
Individuals with AF have a 3 to 5 times greater risk for ischemic stroke and are also at risk for congestive heart failure.
BRINAVESS (vernakalant HCl, IV) is an antiarrhythmic drug that acts preferentially in the atria by prolonging atrial refractoriness and slowing impulse conduction in a rate-dependent fashion.
BRINAVESS is approved for marketing in Europe, Canada and several other countries worldwide. In Europe, it is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: 1) for non-surgery patients: atrial fibrillation < 7 days duration; and 2) for post-cardiac surgery patients: atrial fibrillation < 3 days duration. Vernakalant IV is not approved for use in the United States.
Source: Company Press Release