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  5. Drug Trials Snapshot: Sivextro (tedizolid)
  1. Development & Approval Process | Drugs

Drug Trials Snapshot: Sivextro (tedizolid)

Disclaimer: The Drug Trials Snapshot provides information about who was in the clinical trials that led to the FDA approval of this drug. This website shows who participated in these studies by sex, race, and age groups. You can get more information about this drug from the SIVEXTRO Drug Label and your doctor or health care professional.

SIVEXTRO (tedizolid)
Sih-vex-tro
Cubist Pharms, Inc
Approval date: June 20, 2014


DRUG TRIALS SUMMARY:

What is the drug for?

SIVEXTRO is used to treat serious bacterial skin infections known as acute bacterial skin and skin structure infections (ABSSSI). SIVEXTRO should be used only to treat infections that are proven or strongly suspected to be caused by susceptible strains of Gram-positive microorganisms.

How do I use this drug?

SIVEXTRO is taken as a pill, once a day for six days. For patients not able to take SIVEXTRO by mouth, an intravenous version is also available. The intravenous infusion (IV) is given over a one hour period for six consecutive days.

What are the benefits of this drug?

The results of the clinical study showed a majority of patients treated with SIVEXTRO stopped the spread of their skin infection and eliminated fever within 2-3 days.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race and age.

  • Sex: SIVEXTRO is similarly effective in men and women.
  • Race: Subgroup analyses were conducted for non-whites and whites, but the number of patients in the non-white subgroup was limited. It is not possible to determine whether there were any clinically meaningful differences.
  • Age: Subgroup analyses were conducted for those above and below 65 years of age, but the number of patients above 65 years of age was limited. It is not possible to determine whether there were any clinically meaningful differences.

What are the possible side effects?

The most common side effects that occurred during clinical trials in patients treated with SIVEXTRO were nausea, headache, diarrhea, vomiting, and dizziness.

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race and age.

  • Sex:  The frequency of side effects was similar among men and women.
  • Race:  As the number of patients in the non-white subgroup was limited, it is not possible to determine if there were any clinically meaningful differences.
  • Age:  As the number of patients above 65 years of age was limited, it is not possible to determine if there were any clinically meaningful differences.

WHO WAS IN THE STUDIES?

Who participated in the clinical trials?

The FDA approved SIVEXTRO on evidence from two clinical trials with a total of 1,315 adults who were diagnosed with a bacterial skin infection known as ABSSSI. The studies were conducted in North America, Latin America, Europe, South Africa, Australia and New Zealand.

Figure 1 summarizes how many men and women were enrolled in the clinical trial.

Figure 1. Baseline Demographics by Sex

Source: Adapted from FDA Statistical Review, Table 3-3

Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial.

Baseline Demographics by Race

Source: Adapted from FDA Statistical Review, Table 3-3

Table 1. Baseline Demographics by Race for the Intent to Treat (ITT) Population

Race
Number of Patients Percentage
White 1122 84.2%
Asian 20 1.5%
Black or African American 152 11.4%
Native Hawaiian or Pacific Islander 5 0.4%
American Indian or Alaskan Native 16 1.2%
Other 18 1.4%

Source: Adapted from FDA Statistical Review, Table 3-3

How was the study designed?

SIVEXTRO was approved by the FDA based on two clinical studies of 1333 patients. Chosen at random, 664 patients were given SIVEXTRO and 669 patients received linezolid, which has been the standard therapy for treating ABSSSI. Neither the patients nor the health care professionals administering the drug knew which patients were taking SIVEXTRO and which patients were taking linezolid, until after the study was complete. At 48 and 72 hours, patients were evaluated to see if the infection had stopped spreading and fever was gone.

What are the results of the efficacy study?

Results showed SIVEXTRO was as effective as linezolid for the treatment of ABSSSI in stopping the spread of ABSSSI and eliminating fever within 48 to 72 hours.

What are the results of the trials used to assess safety?

The most common adverse reactions in patients treated with SIVEXTRO were nausea (8%), headache (6%), diarrhea (4%), vomiting (3%), and dizziness (2%). 

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

DRUG LABEL (PDF - 509KB)
MEDICAL REVIEW (PDF - 17MB)