Claims for Patent: 9,867,815

Summary for Patent: 9,867,815

Title:	Pharmaceutical compositions and methods of using the same
Abstract:	Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
Inventor(s):	Moshal; Jeffrey M. (Allentown, PA), Libman; Michael (Allentown, PA)
Assignee:	GENUS LIFESCIENCES INC. (Allentown, PA)
Application Number:	15/470,133
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,867,815
Patent Claims:	1. A method of administering a local anesthetic on a hepatically impaired subject undergoing a procedure, comprising: soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising: about 3.6% to about 4.4% cocaine hydrochloride; about 0.07% to about 0.20% sodium benzoate; about 0.125% citric acid; and optionally, at least one coloring additive; and water, contacting each pledget on a mucous membrane of the hepatically impaired subject for about 20 minutes, and removing each pledget, wherein the hepatically impaired subject has not received topical cocaine hydrochloride within 24 hours prior to administration. 2. The method of claim 1, wherein the procedure comprises at least one of nasal endoscopy, nasal endoscopy with debridement, and nasal endoscopy with polypectomy. 3. The method of claim 1, wherein the procedure comprises nasal endoscopy. 4. The method of claim 1, wherein the procedure comprises nasal laryngoscopy. 5. The method of claim 1, wherein the procedure comprises nasopharyngeal laryngoscopy. 6. The method of claim 1, wherein the procedure comprises nasal debridement. 7. The method of claim 1, wherein the procedure comprises intraturbinate methylprednisolone acetate injection. 8. The method of claim 1, wherein the procedure comprises turbinate reduction. 9. The method of claim 1, wherein the procedure comprises transnasal esophagoscopy. 10. A method of administering a local anesthetic prior to performing a nasal endoscopy on a subject with hepatic or renal impairment comprising: soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising: about 3.6% to about 4.4% cocaine hydrochloride; about 0.07% to about 0.20% sodium benzoate; about 0.125% citric acid; and optionally, at least one coloring additive; and water, contacting each pledget on a nasal mucous membrane of the subject for about 20 minutes, and removing each pledget. 11. The method of claim 10, wherein the hepatic impairment leads to increased systemic exposure of the cocaine hydrochloride. 12. The method of claim 11, wherein the subject has hepatic impairment. 13. The method of claim 12, wherein the subject has a Child-Pugh Grade of Grade B. 14. The method of claim 12, wherein the subject has a Child-Pugh Grade of Grade C. 15. The method of claim 13, wherein a C.sub.max of cocaine is within a 90% confidence interval for Grade B subjects as recited in Table 20. 16. The method of claim 13, wherein an AUC.sub.last of cocaine is within a 90% confidence interval for Grade B subjects as recited in Table 20. 17. The method of claim 14, wherein a C.sub.max of cocaine is within a 90% confidence interval for Grade C subjects as recited in Table 20. 18. The method of claim 14, wherein an AUC.sub.last of cocaine is within a 90% confidence interval for Grade C subjects as recited in Table 20. 19. The method of claim 10, wherein the renal impairment leads to increased systemic exposure of the cocaine hydrochloride. 20. The method of claim 10, wherein the subject has renal impairment. 21. The method of claim 20, wherein, the renally impaired subject has an estimated glomerular filtration rate (eGFR) of about 15 mL/min/1.73 m.sup.2 to about 29 mL/min/1.73 m.sup.2. 22. The method of claim 21, wherein a C.sub.max of cocaine is within a 90% confidence interval for the renally impaired subject as recited in Table 7. 23. The method of claim 21, wherein an AUC.sub.last of cocaine is within a 90% confidence interval for the renally impaired subject as recited in Table 7. 24. The method of claim 21, wherein a CL/F of cocaine is within a 90% confidence interval for the renally impaired subject as recited in Table 7. 25. The method of claim 21, wherein a CLr of cocaine is within a 90% confidence interval for the renally impaired subject as recited in Table 7. 26. A method of administering a local anesthetic on a subject over the age of 65 and undergoing a diagnostic or surgical procedure, comprising: soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising: about 3.6% to about 4.4% cocaine hydrochloride; about 0.07% to about 0.20% sodium benzoate; about 0.125% citric acid; and optionally, at least one coloring additive; and water, contacting each pledget on a mucous membrane of the subject for about 20 minutes, and removing each pledget. 27. The method of claim 26 wherein the subject is over 70 years old. 28. The method of claim 26 wherein the subject is over 80 years old.