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Last Updated: January 20, 2020

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Claims for Patent: 9,775,838

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Summary for Patent: 9,775,838
Title:Nasal drug products and methods of their use
Abstract: Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.
Inventor(s): Keegan; Fintan (Dublin, IE), Bell; Robert Gerard (Clearwater, FL), Crystal; Roger (Santa Monica, CA), Weiss; Michael Brenner (New York, NY)
Assignee: ADAPT PHARMA LIMITED (Dublin, IE) OPIANT PHARMACEUTICALS (Santa Monica, CA)
Application Number:15/589,090
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,775,838
Patent Claims: 1. A method of treating opioid overdose, the method comprising: delivering a 25-200 .mu.L spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient, wherein the device is adapted for nasal delivery, wherein the spray delivers between about 4 mg and about 10 mg naloxone, an isotonicity agent, and between about 0.005% and about 0.015% (w/v) of benzalkonium chloride.

2. The method of claim 1, wherein the spray delivers about 4 mg naloxone.

3. The method of claim 2, wherein the spray delivers about 100 .mu.L of the pharmaceutical solution comprising: about 4% (w/v) naloxone hydrochloride; about 0.74% (w/v) sodium chloride; about 0.01% (w/v) benzalkonium chloride; and about 0.1% (w/v) disodium edetate.

4. The method of claim 1, wherein the spray delivers about 5 mg naloxone.

5. The method of claim 1, wherein the spray delivers about 6 mg naloxone.

6. The method of claim 1, wherein the spray delivers about 7 mg naloxone.

7. The method of claim 1, wherein the spray delivers about 8 mg naloxone.

8. The method of claim 1, wherein the spray delivers about 9 mg naloxone.

9. The method of claim 1, wherein the spray delivers about 10 mg naloxone.

10. The method of claim 9, wherein less than about 5% of the pharmaceutical solution leaves the nasal cavity via drainage into the nasopharynx or externally.

11. The method of claim 9, wherein less than about 20% of the pharmaceutical solution leaves the nasal cavity via drainage into the nasopharynx or externally.

12. The method of claim 11, wherein less than about 10% of the pharmaceutical solution leaves the nasal cavity via drainage into the nasopharynx or externally.

13. The method of claim 1, wherein the spray is delivered as a round spray plume with an ovality ratio less than about 2.0 when measured at 3 cm.

14. The method of claim 13, wherein the ovality ratio is less than about 1.2 when measured at 3 cm.

15. The method of claim 14, wherein the ovality ratio is less than about 1.1 when measured at 3 cm.

16. The method of claim 13, wherein the ovality ratio is less than about 1.5 when measured at 3 cm.

17. The method of claim 16, wherein the ovality ratio is less than about 1.3 when measured at 3 cm.

18. The method of claim 1, wherein the patient is an opioid overdose patient or a suspected opioid overdose patient.

19. The method of claim 18, wherein the patient exhibits one or more symptoms chosen from: respiratory depression, central nervous system depression, cardiovascular depression, altered level consciousness, miotic pupils, hypoxemia, acute lung injury, aspiration pneumonia, sedation, hypotension, unresponsiveness to stimulus, unconsciousness, stopped breathing, erratic or stopped pulse, choking or gurgling sounds, blue or purple fingernails or lips, slack or limp muscle tone, contracted pupils, and vomiting.

20. The method of claim 19, wherein the patient exhibits respiratory depression or cardiovascular depression.

21. The method of claim 20, wherein the respiratory depression is caused by the illicit use of opioids, or by an accidental misuse of opioids.

22. The method of claim 18, wherein the patient is free from respiratory depression for at least about 2 hours following treatment comprising delivery of the therapeutically effective amount of the opioid antagonist.

23. The method of claim 18, wherein the patient is free from respiratory depression for at least about 6 hours following treatment comprising delivery of the therapeutically effective amount of the opioid antagonist.

24. The method of claim 18, wherein the device comprises a reservoir not more than about 140 .mu.L in volume.

25. The method of claim 1, wherein said single actuation yields a plasma concentration of .gtoreq.0.2 ng/mL within 2.5 minutes in said patient.

26. The method of claim 25, wherein said single actuation yields a plasma concentration of .gtoreq.1 ng/mL within 5 minutes in said patient.

27. The method of claim 26, wherein said single actuation yields a plasma concentration of .gtoreq.3 ng/mL within 10 minutes in said patient.

28. The method of claim 1, wherein said single actuation yields a plasma concentration of .gtoreq.0.2 ng/mL within 2.5 minutes in said patient.

29. The method of claim 28, wherein said single actuation yields a plasma concentration of .gtoreq.1 ng/mL within 5 minutes in said patient.

30. The method of claim 1, wherein approximately 100 .mu.L of the pharmaceutical solution is delivered by one actuation of the device.

31. The method of claim 30, wherein the isotonicity agent is present in a concentration between about 0.2% and about 1.2% (w/v).

32. The method of claim 31, wherein the pharmaceutical solution further comprises between about 0.1% and about 0.5% (w/v) of a stabilizing agent and an amount of an acid sufficient to achieve a pH between about 3.5 and about 5.5.

33. The method of claim 32, wherein: the isotonicity agent is sodium chloride; the stabilizing agent is disodium edetate; and the acid is hydrochloric acid.

34. The method of claim 33, wherein the pharmaceutical solution comprises: about 4% (w/v) naloxone hydrochloride; about 0.74% (w/v) sodium chloride; about 0.01% (w/v) benzalkonium chloride; and about 0.1% (w/v) disodium edetate.

35. The method of claim 1, wherein the device has a single reservoir containing approximately 125 .mu.L of the pharmaceutical solution.

36. The method of claim 1, further comprising storing the device for about twelve months or less at 25.degree. C. and 60% relative humidity prior to actuating the device, wherein the device retains at least about 100% of initial naloxone hydrochloride content at actuation.

37. The method of claim 1, wherein the device comprises a reservoir, a piston, and a swirl chamber.

38. The method of claim 37, wherein the device comprises a plunger that houses a container closure comprising a vial comprising an opening, a cannula, and a rubber stopper, wherein the stopper is configured to occlude the opening of the vial, and wherein the cannula is configured such that the cannula can pierce the stopper when the plunger applies sufficient force to the cannula.

39. The method of claim 1, wherein delivery time is less than about 25 seconds.

40. The method of claim 39, wherein delivery time is less than about 20 seconds.

41. A method of treating narcotic-induced respiratory depression, the method comprising: delivering a 25-200 .mu.L spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient in need thereof in a manner that delivers the pharmaceutical solution in a round spray plume with an ovality ratio less than about 2.0 when measured at 3 cm, wherein the device is adapted for nasal delivery, wherein the spray delivers between about 4 mg and about 10 mg naloxone, an isotonicity agent, and between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, wherein the patient is in a lying, supine, or recovery position, and wherein the patient experiences a geometric mean naloxone C.sub.max not less than about 3 ng/mL following a single spray.

42. The method of claim 41, wherein said single actuation yields a plasma concentration of .gtoreq.3 ng/mL within 10 minutes in said patient.

43. The method of claim 42, wherein said single actuation yields a plasma concentration of .gtoreq.0.2 ng/mL within 2.5 minutes in said patient.

44. The method of claim 43, wherein said single actuation yields a plasma concentration of .gtoreq.1 ng/mL within 5 minutes in said patient.

45. The method of claim 41, wherein the patient experiences a geometric mean naloxone C.sub.max not less than about 3 ng/mL following a single spray.

46. The method of claim 45, wherein the patient experiences a plasma naloxone concentration such that the geometric mean of area under a plasma concentration versus time curve (AUC.sub.0-.infin.) is not less than about 8 hr*ng/mL when time is extrapolated to infinity.

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