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Claims for Patent: 8,097,651

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Claims for Patent: 8,097,651

Title:Diclofenac formulations and methods of use
Abstract: Methods and formulations are provided for treating migraine and other acute pain episodes using diclofenac, and formulations of diclofenac that provide both rapid and sustained relief from acute pain. Methods and formulations are also provided for treating symptoms that often accompany migraine and acute pain such as photophobia, phonophobia, nausea and vomiting.
Inventor(s): Reiner; Giorgio (Como, IT), Reiner; Alberto (Como, IT), Meyer; Andreas (Neuenberg, DE)
Assignee: APR Applied Pharma Research s.a. (CH)
Application Number:12/683,517
Patent Claims: 1. A method of treating phonophobia and photophobia in a human patient in need thereof comprising: a) providing an oral formulation comprising one or more pharmaceutically acceptable excipients and 50 mg. of diclofenac or a pharmaceutically acceptable salt thereof, wherein said one or more pharmaceutically acceptable excipients comprises a buffering or alkalizing agent, further wherein said formulation has been shown to achieve a C.sub.max of from about 1500 to about 2500 ng/ml and t.sub.max in from about 10 to about 25 minutes; and b) orally administering said formulation to a patient suffering from phonophobia and photophobia wherein said t.sub.max and C.sub.max are mean values obtained from a plurality of human patients.

2. The method of claim 1 wherein said patient is diagnosed as suffering from migraine requiring sustained migraine relief for at least 24 hours.

3. The method of claim 1 wherein said formulation comprises about 50 mg. of diclofenac potassium, and said buffering or alkalizing agent comprises greater than 20 wt. % of an alkali metal carbonate or bicarbonate based on the weight of the acid form of diclofenac.

4. The method of claim 1 wherein said formulation has been shown to achieve t.sub.max in from about 10 to about 20 minutes.

5. The method of claim 1, wherein said alkaline buffering agent or alkalizing agent is present relative to said diclofenac at a weight ratio of less than about 5:1.

6. A method of treating recurrent migraine in a human patient in need thereof suffering from migraine comprising: a) providing an oral formulation comprising one or more pharmaceutically acceptable excipients and 50 mg. of diclofenac or a pharmaceutically acceptable salt thereof, wherein said one or more pharmaceutically acceptable excipients comprises a buffering or alkalizing agent, further wherein said formulation has been shown to achieve a C.sub.max of from about 1500 to about 2500 ng/ml and t.sub.max in from about 10 to about 25 minutes; and b) orally administering said formulation to a patient requiring sustained migraine relief for at least 24 hours.

7. The method of claim 6 wherein said patient suffers from photophobia and phonophobia.

8. The method of claim 6 wherein said formulation comprises about 50 mg. of diclofenac potassium, and said buffering or alkalizing agent comprises greater than 20 wt. % of an alkali metal carbonate or bicarbonate based on the weight of the acid form of diclofenac.

9. The method of claim 6 wherein said C.sub.max has been shown to have an inter-subject variability of less than about 70%.

10. The method of claim 6 wherein said t.sub.max has been shown to have an inter-subject variability of less than about 70%.

11. The method of claim 6 wherein said formulation has been shown to achieve t.sub.max in from about 10 to about 20 minutes.

12. The method of claim 6, wherein said alkaline buffering agent or alkalizing agent is present relative to said diclofenac at a weight ratio of less than about 5:1.

13. A method of treating headache pain, nausea, photophobia and phonophobia in a human patient in need thereof comprising: a) providing an oral formulation comprising one or more pharmaceutically acceptable excipients and 50 mg. of diclofenac or a pharmaceutically acceptable salt thereof, wherein said one or more pharmaceutically acceptable excipients comprise a buffering or alkalizing agent wherein said formulation has been shown to achieve a C.sub.max of from about 1500 to about 2500 ng/ml and t.sub.max in from about 10 to about 25 minutes; and b) orally administering said formulation to a patient suffering from headache pain, nausea, photophobia and phonophobia.

14. The method of claim 13 further comprising diagnosing said patient suffering from migraine as requiring sustained migraine relief for at least 24 hours and treating recurrent migraine in said patient over a period of 24 hours.

15. The method of claim 13 wherein said C.sub.max has been shown to have an inter-subject variability of less than about 70%.

16. The method of claim 13 wherein said t.sub.max has been shown to have an inter-subject variability of less than about 70%.

17. The method of claim 13 wherein said formulation comprises about 50 mg. of diclofenac potassium, and said alkaline buffering agent or alkalizing agent comprises greater than 20 wt. % of an alkali metal carbonate or bicarbonate based on the weight of the acid form of diclofenac.

18. The method of claim 13 wherein said formulation has been shown to achieve t.sub.max in from about 10 to about 20 minutes.

19. The method of claim 13, wherein said alkaline buffering agent or alkalizing agent is present relative to said diclofenac at a weight ratio of less than about 5:1.
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