Arbor's Sotylize For Arrhythmia Approved By The FDA

Arbor Pharmaceuticals, a specialty pharmaceutical company focused on cardiovascular, pediatric, and hospital markets announced the U.S. Food and Drug Administration (FDA) approval of Sotylize (sotalol hydrochloride) oral solution for the treatment of ventricular arrhythmias. The company’s New Drug Application (NDA) received approval for the treatment of documented life-threatening ventricular arrhythmias as well as the maintenance of normal sinus rhythm in patients known to have highly symptomatic atrial fibrillation/flutter.

The drug contains both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It also comprises a racemic mixture of two isomers, which both carry comparable Class III antiarrhythmic effects.

Ed Schutter, President & CEO of Arbor said, “I am pleased that Arbor's second internally developed NDA was approved in a timely fashion prior to our PDUFA date. We feel that a stable homogenous solution form of sotalol will provide an important treatment option for appropriate patients.” Schutter said that the recent approval expands the company’s portfolio of authorized prescription products to a total of 17.

Dr. Laurence Downey, VP of Medical & Scientific Affairs at Arbor, said, “We are proud to have our second NDA approval in the very short history of our company. Sotylize will play an important role in facilitating how this important drug is administered to patients with serious cardiac conditions.” Prior to the drug’s approval, sotalol was only distributed in tablet form and usually compounded into a liquid suspension. Following the authorization, Sotylize oral solution will be marketed in 5mg/mL strength in 250mL and 480mL bottles.

The company said it will market Sotylize in the first quarter of next year.

Earlier this year, the company announced that the FDA has accepted for review its second NDA for Nymalize (nimodipine) oral solution, indicated to improve neurological outcome through reduction of ischemic deficits in patients with subarachnoid hemorrhage.