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Claims for Patent: 9,375,412

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Claims for Patent: 9,375,412

Title:Treatment of pain with topical diclofenac
Abstract: The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
Inventor(s): Singh; Jagat (Scarborough, CA), Shainhouse; Joseph Zev (North York, CA), Galer; Bradley S. (West Chester, PA), King-Smith; Robert Dominic (San Diego, CA), Grierson; Lisa Marie (Richmond Hill, CA), Burian; Maria (Stolberg, DE), Wilkin; Jonathan (Columbus, OH), Kisak; Edward (San Diego, CA), Newsam; John M. (La Jolla, CA)
Assignee: HZNP Limited (Pembroke, BM)
Application Number:14/810,129
Patent Claims: 1. A method for applying topical agents to a knee of a patient with pain, said method comprising: applying a first medication consisting of a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation consists essentially of 2% w/w diclofenac sodium; about 40% to about 50% w/w dimethyl sulfoxide; about 23-29% w/w ethanol; about 10-12% w/w propylene glycol; about 0-6% w/w hydroxypropylcellulose; and water to make 100% w/w; and wherein the topical diclofenac preparation has a viscosity of 500-5000 centipoise; waiting for the treated area to dry; subsequently applying a sunscreen, or an insect repellant to said treated area after said treated area is dry, wherein said step of applying a first medication does not enhance the systemic absorption of the subsequently applied sunscreen, or insect repellant; wherein said subsequent application occurs during a course of treatment of said patient in which said topical diclofenac preparation is administered twice daily; and counseling said patient to avoid taking unprescribed acetaminophen while using said topical diclofenac preparation.

2. The method according to claim 1, wherein the patient is treated for severe knee pain.

3. The method according to claim 1, wherein the patient is treated for breakthrough knee pain.

4. The method according to claim 1, further comprising: conducting periodic laboratory evaluations regarding said patient and the combination therapy.

5. The method according to claim 1, wherein about 45.5% w/w dimethyl sulfoxide is present in the topical diclofenac preparation.

6. The method according to claim 1, wherein said step of subsequently applying comprises subsequently applying said sunscreen.

7. The method according to claim 6, wherein said sunscreen comprises oxybenzone.

8. The method according to claim 1, wherein said step of subsequently applying comprises subsequently applying said insect repellant.

9. The method according to claim 8, wherein said insect repellant comprises N,N-diethyl-m-toluamide (DEET).

10. The method according to claim 8, wherein said insect repellant comprises 2,4 D dimethylamine salt (2,4 D).

11. A method for applying topical agents to a knee of a patient with pain, said method comprising: applying a first medication comprising a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation consists essentially of 2% w/w diclofenac sodium; about 40% to about 50% w/w dimethyl sulfoxide; about 23-29% w/w ethanol; about 10-12% w/w propylene glycol; about 0-6% w/w hydroxypropylcellulose; and water to make 100% w/w; and wherein the topical diclofenac preparation has a viscosity of 500-5000 centipoise; waiting for the treated area to dry; and subsequently applying a second prescription medication consisting of a topical medication other than said first medication to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient in which said topical diclofenac preparation is administered twice daily; and counseling said patient to avoid taking unprescribed acetaminophen while using said topical diclofenac preparation.

12. The method according to claim 11, wherein about 45.5% w/w dimethyl sulfoxide is present in the topical diclofenac preparation.

13. The method according to claim 11, wherein the topical medication other than said first medication is tretinoin.

14. The method according to claim 11, wherein in the topical medication other than said first medication is minoxidil.

15. The method according to claim 11, wherein the topical medication other than said first medication is a corticosteroid.
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