RESTORE SR study to evaluate vanoxerine for treatment of AF, atrial flutter

Laguna Pharmaceuticals announced the initiation of the phase 3 RESTORE SR study of vanoxerine to assess the drug for the treatment of atrial flutter and atrial fibrillation, according to a press release.

The trial will include 600 patients enrolled throughout the United States and internationally, and will evaluate a 400 mg dose of vanoxerine. RESTORE SR follows results from the phase 2b COR-ART study, in which 400 mg vanoxerine was associated with restoration of sinus rhythm in more than 80% of treated patients, according to the release. The two trials are similar in design, with an identical primary endpoint and a population including patients with structural heart disease.

Results from RESTORE SR are anticipated for the second half of 2016, according to the release.

“Patients suffering with atrial fibrillation currently face few attractive choices in dealing with their condition, and often resort to direct current (DC) cardioversion, an aggressive shock therapy that requires anesthesia and is resource-intensive and unpleasant for patients,” Howard Dittrich, MD, chief medical officer of Laguna, said in the release. “Vanoxerine has the potential to be a transformative therapy in this field by offering a safe and highly effective acute pharmaceutical treatment for patients.”

Disclosure: Dittrich is an employee of Laguna Pharmaceuticals.