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Last Updated: October 23, 2020

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Claims for Patent: 9,629,965

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Summary for Patent: 9,629,965
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): Crystal; Roger (Santa Monica, CA), Weiss; Michael Brenner (New York, NY)
Assignee: Opiant Pharmaceuticals, Inc. (Santa Monica, CA)
Application Number:15/335,145
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,629,965
Patent Claims: 1. A pharmaceutical formulation for intranasal administration comprising, in an aqueous solution of not more than about 140 .mu.L: about 4 mg naloxone hydrochloride; about 0.74 mg NaCl; about 0.01 mg benzalkonium chloride; about 0.2 mg disodium edetate; and an amount of hydrochloric acid sufficient to achieve a pH of 3.5-5.5.

2. The pharmaceutical formulation of claim 1, wherein the aqueous solution has a volume of 100 .mu.L.

3. The pharmaceutical formulation of claim 1, which yields, when intranasally administered to a patient, a mean naloxone plasma concentration of .gtoreq.0.2 ng/mL within 2.5 minutes in said patient.

4. The pharmaceutical formulation of claim 1, which yields, when intranasally administered to a patient, a mean naloxone plasma concentration of .gtoreq.1 ng/mL within 5 minutes in said patient.

5. The pharmaceutical formulation of claim 1, which yields, when intranasally administered to a patient, a mean naloxone plasma concentration of .gtoreq.3 ng/mL within 10 minutes in said patient.

6. The pharmaceutical formulation of claim 1, which yields, when intranasally administered to a patient, a naloxone T.sub.max of less than 30 minutes.

7. The pharmaceutical formulation of claim 1, which yields, when intranasally administered to a patient, a naloxone T.sub.max of less than 25 minutes.

8. The pharmaceutical formulation of claim 1, which yields, when intranasally administered to a patient, a naloxone T.sub.max of less than 20 minutes.

9. A method of treatment of opioid overdose or a symptom thereof, comprising: nasally administering to a patient in need thereof the pharmaceutical formulation of claim 1.

10. The method of claim 9, wherein upon nasal delivery of said pharmaceutical composition to said patient, less than about 20% of said pharmaceutical composition leaves the nasal cavity via drainage into the nasopharynx or externally.

11. The method of claim 9, wherein upon nasal delivery of said pharmaceutical composition to said patient, less than about 10% of said pharmaceutical composition leaves the nasal cavity via drainage into the nasopharynx or externally.

12. The method of claim 9, wherein upon nasal delivery of said pharmaceutical composition to said patient, less than about 5% of said pharmaceutical composition leaves the nasal cavity via drainage into the nasopharynx or externally.

13. The method of claim 9, wherein the plasma concentration versus time curve of said naloxone hydrochloride in said patient has a T.sub.max of between about 20 and about 30 minutes.

14. The method of claim 9, wherein the administration yields a mean naloxone plasma concentration of .gtoreq.0.2 ng/mL within 2.5 minutes in said patient.

15. The method of claim 9, wherein the administration yields a mean naloxone plasma concentration of .gtoreq.1 ng/mL within 5 minutes in said patient.

16. The method of claim 9, wherein the administration yields a mean naloxone plasma concentration of .gtoreq.3 ng/mL within 10 minutes in said patient.

17. The method of claim 9, wherein said patient is an opioid overdose patient or a suspected opioid overdose patient.

18. The method of claim 17, 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.

19. The method of claim 17, wherein the patient exhibits respiratory depression.

20. A single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which comprises per 100 .mu.L of aqueous solution: about 4 mg naloxone hydrochloride or a hydrate thereof; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a preservative; between about 0.1 mg and about 0.5 mg of a stabilizing agent; and an amount of an acid sufficient to achieve a pH of 3.5-5.5.

21. The device as recited in claim 20, wherein: the isotonicity agent is NaCl; the preservative is benzalkonium chloride; the stabilizing agent is disodium edetate; and the acid is hydrochloric acid.

22. The device of claim 20, wherein the aqueous solution comprises per 100 .mu.L: about 4 mg naloxone hydrochloride; about 0.74 mg NaCl; about 0.01 mg benzalkonium chloride; about 0.2 mg disodium edetate; and an amount of hydrochloric acid sufficient to achieve a pH of 3.5-5.5.

23. The device of claim 20, wherein said device is actuatable with one hand.

24. The device of claim 20, wherein the volume of said reservoir is not more than about 140 .mu.L.

25. The device of claim 20, wherein about 100 .mu.L of said aqueous solution in said reservoir is delivered to said patient in one actuation.

26. The device of claim 20, wherein the pharmaceutical composition which is an aqueous solution comprises about 4 mg naloxone hydrochloride.

27. The device of claim 20, wherein the device is configured such that the 90% confidence interval for dose delivered per actuation is .+-. about 2%.

28. The device of claim 20, wherein the device is configured such that the 95% confidence interval for dose delivered per actuation is .+-. about 2.5%.

29. The device of claim 20, wherein the device is configured such that the delivery time is less than about 25 seconds.

30. The device of claim 20, wherein the device is configured such that the delivery time is less than about 20 seconds.

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