Claims for Patent: 9,265,740
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Summary for Patent: 9,265,740
Title: | Minocycline compounds and methods of use thereof |
Abstract: | Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said infection is selected from the group consisting of MSSA, MRSA, B-streptococci, Viridans Streptococci, Enterococcus, or combinations thereof. |
Inventor(s): | Johnston; Sean M. (Doylestown, PA), Arbeit; Robert D. (W. Newton, MA), Bigger; Thomas J. (Norwell, MA), Molnar; Dennis P. (Hopkinton, MA), Tanaka; S. Ken (Needham, MA) |
Assignee: | Paratek Pharmaceuticals, Inc.-124418 (Boston, MA) |
Application Number: | 14/258,847 |
Patent Claims: |
1. A method of treating a human subject for complicated Skin and Skin Structure Infections, comprising orally administering to said subject an effective amount of
9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein gastrointestinal (GI) adverse events (AEs) associated with treatment are mild.
2. The method of claim 1, wherein said salt is a hydrochloride salt. 3. The method of claim 1, wherein said salt is a tosylate salt. 4. The method of claim 1, wherein said subject is suffering from injury, major abscess, or cellulitis. 5. The method of claim 4, wherein said injury is a traumatic injury. 6. The method of claim 1, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at dose of about 100 mg to about 300 mg per day. 7. The method of claim 6, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 200 mg per day. 8. The method of claim 1, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline has a clinical success rate of treating an infection of greater than about 93.2%. 9. The method of claim 1, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline has a microbiologically evaluable clinical success rate of treating an infection of greater than about 93.7%. 10. A pharmaceutical composition comprising from about 100 to about 300 mg of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof and a pharmaceutically acceptable carrier for oral administration. 11. The pharmaceutical composition of claim 10, wherein said composition comprises about 200 mg of said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline. 12. A pharmaceutical composition comprising from about 50 to about 150 mg of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof and a pharmaceutically acceptable carrier for intravenous administration. 13. The pharmaceutical composition of claim 12, wherein said composition comprises about 100 mg of said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline. 14. The pharmaceutical composition of claim 10, wherein said composition comprises about 150 mg of said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline. 15. The method of claim 1, wherein said skin and skin structure infections are caused by Staphylococcus aureus, Streptococci, or a combination thereof. 16. The method of claim 15, wherein said Staphylococcus aureus is methicillin-resistant Staphylococcus aureus (MRSA), or methicillin-susceptible Staphylococcus aureus (MSSA). 17. The method of claim 15, wherein said Streptococci is beta Streptococci. 18. The method of claim 15, wherein said Streptococci is Streptococcus pyogenes. 19. The method of claim 1, wherein said skin and skin structure infections are characterized by the presence of one or more of erythema, edema, and induration. 20. The method of claim 1, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered once per day. 21. The method of claim 1, wherein said subject is treated up to and including about 14 days, up to and including about 10 days, up to and including about 9 days, up to and including about 8 days, or up to and including about 7 days, such that said subject is treated. 22. The method of claim 1, wherein GI adverse events (AEs) associated with treatment do not result in discontinuation of therapy. 23. The method of claim 6, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 300 mg per day. |
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