Generic Name: tedizolid phosphate
Date of Approval: June 20, 2014
Company: Cubist Pharmaceuticals, Inc.

Treatment for: Acute Bacterial Skin and Skin Structure Infections

FDA Approves Sivextro

The U.S. Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Tedizolid phosphate (Sivextro) is the second drug in the oxazolidinone class of antibacterial agents to be approved by the FDA, following linezolid (Zyvox) in April 2000. Like Zyvox, Sivextro is available in both intravenous (I.V.) and oral formulations, but with the newer drug comes less frequent dosing, shorter treatment times, and an improved side effect profile over the first-in-class drug. Sivextro is administered once daily, and provides an effective, six-day course of therapy which could reduce the need for costly hospitalization. Tablets may be taken with or without food and without any dietary restrictions.

The U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of tedizolid phosphate on March 31, 2014. The New Drug Application (NDA) was supported by two global Phase 3 studies which demonstrated that tedizolid phosphate 200 mg administered once daily for six days was statistically non-inferior to 600 mg of linezolid taken twice a day for 10 days.

Sivextro is designated as a Qualified Infectious Disease Product (QIDP) as it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. Dalvance (dalbavancin), which is also used to treat ABSSSI, was the first QIDP to receive FDA approval in May 2014.

Sivextro, like all antibacterial drugs, should only be used to treat bacterial infections. It should be taken exactly as directed as skipping doses or not completing the full course of therapy may not only decrease the effectiveness of the immediate treatment, but also increase the likelihood that bacteria will develop resistance.

The most common side effects for Sivextro are nausea, headache, diarrhea, vomiting, and dizziness. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Sivextro. Patients should you should contact their healthcare provider if severe watery or bloody diarrhea develops during treatment.

Sivextro is distributed by Cubist Pharmaceuticals U.S. in Lexington, MA.