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The U.S. Food and Drug Administration approved two medications in June that may benefit long-term care patients.

In June, the FDA approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. This comes on the heels of the May approval of Dalvance, an intravenous antibiotic to treat acute bacterial skin and skin structure infections (ABSSSI).

Sivextro also is approved to treat patients with ABSSSI caused by certain bacteria, including Staphylococcus aureus (including methicillin-resistant strains and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. It can be used intravenously or orally. Sivextro was evaluated in two clinical trials with 1,315 adults with ABSSSI.

The FDA also approved Afrezza Inhalation Powder, a rapid-acting inhaled insulin to help glycemic control in adults with diabetes mellitus. Afrezza is taken at the beginning of each meal. It is manufactured by Connecticut-based MannKind Corporation.

Afrezza broadens the options for delivering meal time insulin, said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. The drug was tested in 3,017 patients, one-third of whom had type 1 diabetes and the rest who had type 2 diabetes. Both groups had a significant mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin), which is a measure of blood sugar control.

Afrezza is not a substitute for long-acting insulin, and is not recommended for treatment of diabetic ketoacidosis, or for patients who smoke. 

It is now required that a clinical trial evaluate the safety and efficacy of Afrezza in pediatric patients, as well as a trial to evaluate the risk for pulmonary malignancy, plus two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials.