FDA Approves Arbor's Sotylize For Arrhythmias, Atrial Fibrillation
By Cyndi Root
Arbor Pharmaceuticals has provided a new sotalol hydrochloride oral solution, Sotylize, for treatment of ventricular arrhythmias and maintenance of normal sinus rhythm in patients with atrial fibrillation/flutter. The company announced the Food and Drug Administration (FDA) approval in a press release, stating that it will launch the new medication in the first quarter of 2015. Ed Schutter, President and CEO of Arbor said, "We feel that a stable homogenous solution form of sotalol will provide an important treatment option for appropriate patients. Sotylize adds to our growing portfolio of now seventeen different approved prescription products that may help to improve the lives of our patients."
Sotylize
Sotylize changes how sotalol hydrochloride is administered to cardiac patients. Before the approval of the oral solution, pharmacists were crushing the sotalol tablet and suspending it in a simple syrup liquid solution. This was a common practice to accommodate patients who could not swallow pills, such as pediatric and elderly patients. The FDA acquiesced to the practice by amending the label, giving pharmacists instructions on how to make the sotalol oral solution.
The antiarrhythmic agent is indicated for two types of patients. One type of patient has, in the judgment of physicians, life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. The other type of patient has highly
symptomatic atrial fibrillation/flutter (AFIB/AFL) and needs to maintain normal sinus rhythm or delay the time in recurrence of AFIB/AFL.
About Arbor
Arbor Pharmaceuticals is headquartered in Atlanta, Georgia. The specialty pharmaceutical company currently focuses on the cardiovascular, hospital, and pediatric markets. Currently the company markets 17 NDA and ANDA approved products and has over 40 compounds in development. In clinical development are AR05 and AR06 for cardiology, AR08 for pediatrics/psychiatry, AR02 and AR10 for hospital use.
Sotylize is the company’s second FDA-approved drug, following Nymalize (nimodipine) oral solution, which was approved in May of 2013. The oral solution Nymalize is indicated for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage (SAH). Before the approval of Nymalize, nimodipine was only available in gel capsule form. Healthcare providers were extracting the medication from the gel capsule with a syringe and injecting the agent intravenously, instead of administering it orally through an enteral syringe. In 2010, the FDA reported twenty-five intravenous nimodipine adverse events including 4 deaths and 5 near-deaths.