METHODS OF TREATING MYCOBACTERIAL INFECTIONS USING TETRACYCLINE COMPOUNDS
The present invention provides methods of treating mycobacterial infections or mycobacterial diseases by administering a tetracycline compound, e.g., omadacycline, or a pharmaceutically acceptable salt thereof.
1 - 195 . (canceled)
196 . A method of treating or preventing a pulmonary disease in a subject in need thereof, said method comprising administering to said subject an effective amount of omadacycline represented by formula (5):
or a pharmaceutically acceptable salt thereof, wherein said pulmonary disease is caused by an infection with a rapid-growing nontuberculous Mycobacterium (NTM).
197 . The method of claim 196 , wherein the rapid-growing NTM belongs to a mycobacterial species M. abscessus.
198 . The method of claim 197 , wherein the rapid-growing NTM belongs to a mycobacterial species selected from the group consisting of M. abscessus subsp. abscessus, M. abscessus subsp. bolletii , and M. abscessus subsp. Massiliense.
199 . The method of claim 196 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered parenterally, orally, topically or via an aerosol.
200 . The method of claim 199 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered orally.
201 . The method of claim 200 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered orally at a dose of about 150 to about 600 mg.
202 . The method of claim 201 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered orally at a dose of about 150, about 300 mg, about 450 mg or about 600 mg.
203 . The method of claim 196 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered once daily.
204 . The method of claim 196 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered for a period of time lasting from about 1 month to about 24 months.
205 . The method of claim 196 , wherein the subject is a human.
206 . A method of controlling or reducing the advancement, severity or effects of a pulmonary disease in a subject in need thereof, said method comprising administering to said subject an effective amount of omadacycline represented by formula (5):
or a pharmaceutically acceptable salt thereof, wherein said pulmonary disease is caused by an infection with a rapid-growing nontuberculous Mycobacterium (NTM).
207 . The method of claim 206 , wherein the rapid-growing NTM belongs to a mycobacterial species M. abscessus.
208 . The method of claim 207 , wherein the rapid-growing NTM belongs to a mycobacterial species selected from the group consisting of M. abscessus subsp. abscessus, M. abscessus subsp. bolletii , and M. abscessus subsp. Massiliense.
209 . The method of claim 206 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered parenterally, orally, topically or via an aerosol.
210 . The method of claim 209 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered orally.
211 . The method of claim 210 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered orally at a dose of about 150 to about 600 mg.
212 . The method of claim 211 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered orally at a dose of about 150, about 300 mg, about 450 mg or about 600 mg.
213 . The method of claim 206 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered once daily.
214 . The method of claim 206 , wherein omadacycline, or a pharmaceutically acceptable salt thereof, is administered for a period of time lasting from about 1 month to about 24 months.
215 . The method of claim 206 , wherein the subject is a human.