Claims for Patent: 10,512,620

Summary for Patent: 10,512,620

Title:	Method of initiating and escalating sotalol hydrochloride dosing
Abstract:	This disclosure provides method of safely and efficaciously treating or preventing atrial fibrillation, atrial flutter, or a combination thereof via rapid intravenous introduction of sotalol hydrochloride to a subject in need thereof.
Inventor(s):	Somberg; John Charin (Chicago, IL), Kashfian; Brandon Ira (Chicago, IL), Molnar; Janos (Chicago, IL)
Assignee:	AltaThera Pharmaceuticals, LLC (Chicago, IL)
Application Number:	16/103,815
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,512,620
Patent Claims:	1. A method of preventing atrial fibrillation, atrial flutter, or a combination thereof in a subject at risk of a recurrence of atrial fibrillation, atrial flutter, or a combination thereof, the method, comprising: (a) intravenously administering to the subject, who has been admitted to a hospital, between about 0.825 mg/min and about 1.17 mg/min of sotalol hydrochloride over a period of about 60 minutes to achieve a sotalol steady state C.sub.max of between about 750 ng/mL and about 850 ng/mL in the subject; (b) orally administering to the subject 80 mg of sotalol hydrochloride between about 2 hours and about 6 hours after completion of the intravenous administration; (c) initiating an oral BID administration regimen of 80 mg of sotalol hydrochloride about 12 hours after the oral administration; and, (d) discharging the subject from the hospital 18 to 24 hours after initiation of intravenous sotalol administration; wherein the subject achieves a sotalol steady state C.sub.max of between about 750 ng/mL and about 850 ng/mL once after the intravenous dosage, a second time after the oral dosage, and a third time after the initiation of oral BID dosage, which allows for the QTc interval of the subject corresponding to the full concentration effect of sotalol to be assessed. 2. The method of claim 1, wherein about 64 mg of sotalol is administered intravenously. 3. The method of claim 1, wherein sotalol is orally administered about 2 hours after completion of the intravenous administration. 4. The method of claim 1, wherein sotalol is orally administered about 3 hours after completion of the intravenous administration. 5. The method of claim 1, wherein the patient is discharged from 20 to 24 hours after initiation of intravenous sotalol administration. 6. The method of claim 1, wherein the patient is discharged 24 hours after initiation of intravenous sotalol administration. 7. The method of claim 1, wherein the subject had received 80 mg of oral sotalol hydrochloride about 12 to about 24 hours prior to receiving the intravenous sotalol hydrochloride; in step (a), the subject achieves a sotalol steady state C.sub.max of between about 1150 ng/mL and about 1250 ng/mL in the subject; in step (b), 120 mg of sotalol hydrochloride is orally administered; and, in step (c), an oral BID administration regimen of 120 is initiated; wherein the subject achieves a sotalol steady state C.sub.max of between about 1150 ng/mL and about 1250 ng/mL once after the intravenous dosage, a second time after the oral dosage, and a third time after the initiation of oral BID dosage, which allows for the QTc interval of the subject corresponding to the full concentration effect of sotalol to be assessed. 8. The method of claim 7, wherein the subject had received 80 mg of oral sotalol hydrochloride about 12 hours prior to receiving the intravenous sotalol hydrochloride. 9. The method of claim 7, wherein about 64 mg of sotalol is administered intravenously. 10. The method of claim 7, wherein sotalol is orally administered about 4 hours after completion of the intravenous administration. 11. The method of claim 7, wherein sotalol is orally administered about 5 hours after completion of the intravenous administration. 12. The method of claim 7, wherein the patient is discharged from 20 to 24 hours after initiation of intravenous sotalol administration. 13. The method of claim 7, wherein the patient is discharged 24 hours after initiation of intravenous sotalol administration. 14. The method of claim 1, wherein the subject had received 120 mg of oral sotalol hydrochloride about 12 to about 24 hours prior to receiving the intravenous sotalol hydrochloride; in step (a), between about 1.05 mg/min and about 1.47 mg/min of sotalol hydrochloride is intravenously administered to achieve a sotalol steady state Cmax of between about 1550 ng/mL and about 1650 ng/mL in the subject; in step (b), 160 mg of sotalol hydrochloride is orally administered; and, in step (c), an oral BID administration regimen of 160 is initiated; wherein the subject achieves a sotalol steady state C.sub.max of between about 1550 ng/mL and about 1650 ng/mL once after the intravenous dosage, a second time after the oral dosage, and a third time after the initiation of oral BID dosage, which allows for the QTc interval of the subject corresponding to the full concentration effect of sotalol to be assessed. 15. The method of claim 14, wherein the subject had received 120 mg of oral sotalol hydrochloride about 12 hours prior to receiving the intravenous sotalol hydrochloride. 16. The method of claim 14, wherein about 96 mg of sotalol is administered intravenously. 17. The method of claim 14, wherein sotalol is orally administered about 4 hours after completion of the intravenous administration. 18. The method of claim 14, wherein sotalol is orally administered about 5 hours after completion of the intravenous administration. 19. The method of claim 14, wherein the patient is discharged from 20 to 24 hours after initiation of intravenous sotalol administration. 20. The method of claim 14, wherein the patient is discharged 24 hours after initiation of intravenous sotalol administration.