Claims for Patent: 10,413,505

Summary for Patent: 10,413,505

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:	15/934,562
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,413,505
Patent Claims:	1. A method of providing induction of local anesthesia of mucous membranes in adult patients comprising: soaking four cottonoid pledgets in the contents of one bottle containing about 4 mL of a pharmaceutical composition comprising about 36 mg/mL to 44 mg/mL of naturally derived cocaine hydrochloride, until each pledget absorbs about 40 mg of naturally derived cocaine hydrochloride, contacting two pledgets in each nasal cavity against a septum of a patient for a period ranging from about 10 minutes to about 20 minutes, provided that the method results in a maximum plasma concentration C.sub.max in a range from about 19.7 ng/mL to about 54.3 ng/mL of cocaine in the patient; and performing a procedure on the patient, the procedure selected from the group consisting of a nasal laryngoscopy, a nasopharyngeal laryngoscopy, and a nasal debridement, provided that the method results in a reduction in pain equivalent to achieving a visual numeric rating score of 0 upon von Frey filament testing. 2. The method of claim 1, wherein the procedure is a nasal laryngoscopy. 3. The method of claim 1, wherein the procedure is a nasopharyngeal laryngoscopy. 4. The method of claim 1, wherein the procedure is a nasal debridement. 5. The method of claim 1, wherein a length of each pledget is from about 3.0 cm to about 8.0 cm. 6. The method of claim 1, wherein a height of each pledget is about 1.3 cm and a length of each pledget is about 4 cm. 7. The method of claim 1, wherein the C.sub.max is about 37 ng/mL. 8. A method of providing induction of local anesthesia of mucous membranes in adult patients comprising: soaking four cottonoid pledgets in the contents of one bottle containing about 4 mL of a pharmaceutical composition comprising about 36 mg/mL to 44 mg/mL of naturally derived cocaine hydrochloride, until each pledget absorbs about 40 mg of naturally derived cocaine hydrochloride; contacting two pledgets in each nasal cavity against a septum of a patient in a range from about 10 minutes to about 20 minutes, provided that the method results in an AUC.sub.inf in a range from about 30.8 ng*h/mL to about 79.0 ng*h/mL of cocaine in the patient; and performing a procedure on the patient, the procedure selected from the group consisting of a nasal laryngoscopy, a nasopharyngeal laryngoscopy, and a nasal debridement, provided that the method results in a reduction in pain equivalent to achieving a visual numeric rating score of 0 upon von Frey filament testing. 9. The method of claim 8, wherein a length of each pledget is from about 3.0 cm to about 8.0 cm. 10. The method of claim 8, wherein a height of each pledget is about 1.3 cm and a length of each pledget is about 4 cm. 11. The method of claim 8, wherein the AUC.sub.inf is about 54.9 ng*h/mL. 12. The method of claim 8, wherein the procedure is a nasal laryngoscopy. 13. The method of claim 8, wherein the procedure is a nasopharyngeal laryngoscopy. 14. The method of claim 8, wherein the procedure is a nasal debridement. 15. The method of claim 8, wherein the achieved AUC.sub.inf ranges from about 30.8 ng*h/mL to about 54.9 ng*h/mL of cocaine in the patient. 16. The method of claim 8, wherein the achieved AUC.sub.inf ranges from about 54.9 ng*h/mL to about 79.0 ng*h/mL of cocaine in the patient.