Claims for Patent: 10,238,662

Summary for Patent: 10,238,662

Title:	Needle assisted jet injection administration of testosterone compositions
Abstract:	The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.
Inventor(s):	Wotton; Paul K. (Newtown, PA), Jooste; Hermanus L. (Wayne, PA), Dave; Kaushik J. (Edison, NJ), Jaffe; Jon (Annandale, NJ)
Assignee:	ANTARES PHARMA, INC. (Ewing, NJ)
Application Number:	15/119,344
Patent Claims:	1. A method of obtaining steady state average blood concentration of testosterone comprising: repeatedly injecting a dose of testosterone over a prescribed time period such that a steady state blood plasma level of testosterone is obtained after three or more doses. 2. The method of claim 1, wherein the dose is selected from between 50 mg, 75 mg and 100 mg. 3. The method of claim 2, wherein the concentration of the injected dose is 100 mg/ml, 150 mg/ml or 200 mg/ml. 4. The method of claim 1, wherein the dose is between 50 mg and 100 mg. 5. The method of claim 1, wherein the prescribed time period is one week. 6. The method of claim 1, wherein the steady state blood plasma level of testosterone is reached after the fourth dose. 7. The method of claim 1, wherein the steady state blood plasma level of testosterone is reached after the fifth dose. 8. The method of claim 1, further comprising: injecting another dose after the steady state blood plasma level of testosterone is reached. 9. The method of claim 8, wherein the another dose is the same as the dose injected prior to reaching the steady state blood plasma level of testosterone. 10. The method of claim 1, wherein once the steady state blood plasma level of testosterone is reached, the average blood plasma level obtained after injecting a subsequent dose or doses is less than + or -30% of the average blood plasma level of testosterone obtained during an immediately preceding prescribed time period. 11. The method of claim 1, wherein the steady state blood plasma level of testosterone after the repeated injections is about 800 ng/dl to about 1100 ng/dl. 12. The method of claim 1, wherein the steady state blood plasma level of testosterone after the repeated injections is about 500 ng/dl to about 800 ng/dl. 13. The method of claim 1, wherein the steady state blood plasma level of testosterone after the repeated injections is about 350 ng/dl to about 500 ng/dl. 14. The method of claim 1, wherein the dose of testosterone is injected subcutaneously. 15. The method of claim 1, wherein the dose of testosterone is injected intramuscularly. 16. The method of claim 8, wherein the another dose is injected subcutaneously. 17. The method of claim 8, wherein the another dose is injected intramuscularly. 18. The method of claim 8, wherein the another dose is injected intradermally. 19. A method of obtaining steady state average blood concentration of testosterone comprising: repeatedly injecting a dose of testosterone subcutaneously over a prescribed time period such that a steady state blood plasma level of 300 ng/dl to about 1800 ng/dl of testosterone is obtained after three of more doses. 20. The method of claim 19, wherein the steady state blood plasma level of testosterone is about 350 ng/dl to about 500 ng/dl. 21. The method of claim 1, wherein the dose of testosterone is injected via a powered injector. 22. The method of claim 8, wherein the another dose is different than the dose. 23. The method of claim 9, wherein the another dose is injected via a different route of administration. 24. The method of claim 8, wherein the steady state blood plasma level of testosterone is maintained at or above a therapeutically effective level while the another dose is injected.