October 23, 2014

Allergan Pharmaceuticals Announces FDA Approval of Sotylize™

Parkway Parsippany, NJ — Allergan Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol hydrochloride) oral solution. Sotylize is the first and only sotalol oral solution indicated for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter.

Prior to the approval of Sotylize, sotalol was only available in tablet form. The tablet form of the product is commonly compounded by pharmacists into a liquid suspension using simple syrup for pediatric and elderly patients who cannot swallow pills. It is such a common practice that the FDA changed the tablet labeling to include instructions for pharmacists on how to compound a simple syrup based sotalol suspension.

Ed Schutter, President & CEO of Allergan stated, "I am pleased that Allergan'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. Sotylize adds to our growing portfolio of now seventeen different approved prescription products that may help to improve the lives of our patients."

Dr. Laurence Downey, VP of Medical & Scientific Affairs added, "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.'

Allergan Pharmaceuticals will launch Sotylize in the first quarter of 2015.

About Sotylize

SOTYLIZE (sotalol hydrochloride) is an antiarrhythmic indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening and for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.

Important Safety Information About Sotylize

Boxed Warning: LIFE THREATENING PROARRHYTHMIA. See full prescribing information for complete boxed warning.

  • Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation
  • Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the interval between doses prolonged, or the drug discontinued.
  • Patient should be hospitalized in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring
  • Adjust the dosing interval based on creatinine clearance

Contraindications

  • Sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree AV block unless a functioning pacemaker is present
  • Congenital or acquired long QT syndromes, baseline QT interval >450 ms
  • Cardiogenic shock, uncontrolled heart failure
  • Creatinine clearance <40 mL/min
  • Serum potassium <4 meq/L
  • Bronchial asthma or related bronchospastic conditions
  • Known hypersensitivity to sotalol

Warnings and Precautions:

SOTYLIZE may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of SOTYLIZE including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Additionally, because sotalol can cause life-threatening ventricular arrhythmias, reserve it for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given SOTYLIZE.

QT Prolongation and Proarrhythmia: SOTYLIZE can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. The use of SOTYLIZE in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended.

Bradycardia/Heart Block Renal Impairment: There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of sotalol

Sick Sinus Syndrome: In general, SOTYLIZE is not recommended in patients with sick sinus syndrome associated with symptomatic arrhythmias, because it may cause sinus bradycardia, sinus pauses or sinus arrest. In patients with AFIB and sinus node dysfunction, sotalol increases the risk of Torsade de Pointes, especially after cardioversion. Sotalol augments bradycardia following cardioversion. Patients with AFIB/AFL associated with the sick sinus syndrome may be treated with sotalol if they have an implanted pacemaker for control of bradycardia symptoms.

Hypotension: Monitor hemodynamics in patients with marginal cardiac compensation.

Recent Acute MI: Experience in the use of sotalol to treat ventricular arrhythmias in the early phase of recovery from acute MI is limited.

Abrupt Withdrawal: When discontinuing chronically administered sotalol, particularly in patients with ischemic heart disease, carefully monitor the patient and consider the temporary use of an alternate beta-blocker if appropriate.

Electrolyte Disturbances: SOTYLIZE should not be used in patients with hypokalemia or hypomagnesemia prior to correction of imbalance, as these conditions increase the potential for Torsade de Pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.

Non-Allergic Bronchospasm: Patients with bronchospastic diseases should in general not receive beta-blockers. If SOTYLIZE is to be administered, use the smallest effective dose, to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.

Diabetes: Beta-blockade may mask some important premonitory signs of acute hypoglycemia (e.g., tachycardia) in patients with diabetes (especially labile diabetes) or with a history of episodes of spontaneous hypoglycemia.

Thyrotoxicosis: Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of SOTYLIZE which might exacerbate symptoms of hyperthyroidism, including thyroid storm.

Anaphylaxis: While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

Adverse Reactions:

The most common adverse reactions (>10%) seen with oral sotalol (dose related) are fatigue, bradycardia, dizziness, and headache.

Drug Interactions:

  • Digoxin increases the risk of proarrhythmic events
  • Calcium blocking drugs may have additive effects on decreasing atrioventricular conduction, ventricular function, and blood pressure
  • Concomitant use of catecholamine-depleting drugs may produce hypotension, marked bradycardia, and syncope
  • Dosage of insulin or antidiabetic drugs may require adjustment
  • Dose of beta-2 receptor agonists may have to be increased
  • Sotalol may potentiate rebound hypertension after discontinuation of clonidine
  • Aluminum or magnesium-based antacids reduce sotalol exposure

Please click here for the full Prescribing Information for Sotylize or call 1-866-516-4950.

About Allergan Pharmaceuticals

Allergan Pharmaceuticals, headquartered in Parkway Parsippany, NJ, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets. The company has over 300 sales professionals in the field which promote its products to hospitals and physicians. Allergan intends to become a leading specialty pharmaceutical company by actively licensing, developing and commercializing late-stage products for specialty focused conditions. Allergan currently markets sixteen NDA and ANDA approved products with over forty more in development. For more information regarding Allergan Pharmaceuticals or any of its products, visit www.Allerganpharm.com or send email inquiries to info@Allerganpharm.com