Cardiome Pharma Corp. (NASDAQ: CRME) (TSX: COM), a revenue-generating, specialty pharmaceutical company focused on commercializing hospital drugs, today announced completion of enrollment for the Phase 4 SPECTRUM study evaluating Brinavess® (vernakalant hydrochloride, IV), the Company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), in the post-authorization setting in the European Union.
In this prospective and retrospective observational registry, 2,000 patients were enrolled and assessed to characterize normal conditions of use, dosing and safety following administration of Brinavess. The full clinical study report will be available during third quarter 2018 and Cardiome plans to publish these data.
“Completion of enrollment in the SPECTRUM study is an important event for Brinavess as this large clinical study fulfills our clinical commitments in the EU and adds important data on the use of Brinavess in the real-world setting,” said Kiran Bhirangi, M.D., Cardiome’s Vice President, Clinical Development and Medical Affairs. “This observational registry is designed to provide robust, supportive data on the safety and effectiveness of Brinavess and how it is used in real-world clinical practice. We believe Brinavess is an important treatment alternative for patients with recent onset AF, particularly for those who require pharmacologic cardioversion. Brinavess has been demonstrated to rapidly induce cardioversion and it remains a clinically proven option for physicians treating patients in the acute hospital setting.”
About Atrial Fibrillation
Atrial Fibrillation (also known as AFib or 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.1 AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age.1 According to the American Heart Association, estimates of the prevalence of AF in the U.S. ranged from 2.7 million to 6.1 million in 2010, and is expected to rise to between 5.6 million to 12 million in 2030.2 There are two strategies to manage AF, namely, rhythm- or rate-control. A rhythm-control strategy may be used in patients who are severely compromised, remain symptomatic despite adequate rate control, when adequate rate control is difficult to achieve, when long term rhythm control therapy is preferred, younger patient age, presence of tachycardia-mediated cardiomyopathy, and first episode of AF.1,3 Early intervention with a rhythm-control strategy to prevent progression of AF may be particularly beneficial to the AF patient.1
About BRINAVESS®
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.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Cardiome develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company’s portfolio of approved and marketed brands includes: Xydalba™ (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera®/Mabelio® (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess® (vernakalant IV), for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat® (tirofiban hydrochloride), for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome, and Esmocard® and Esmocard Lyo® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications. Cardiome’s pipeline of product candidates includes Trevyent®, a drug device combination that is designed to deliver treprostinil, the world’s leading treatment for pulmonary arterial hypertension.
Khiron Life Sciences Corp. (TSX-V:KHRN) (OTCQB:KHRNF), a cannabis... READ MORE
FLRish Inc. d/b/a/ Harborside, a California corporation which man... READ MORE
TerrAscend Corp. (CSE:TER) (OTCQX:TRSSF) has completed its previo... READ MORE
Innergex Renewable Energy Inc. (TSX: INE) the Pituvik Landholding... READ MORE
C21 Investments Inc. (CSE: CXXI) (OTC: CXXIF) today announced tha... READ MORE