viernes, 7 de julio de 2017

Drug Approvals and Databases > Drug Trials Snapshots: BAXDELA

Drug Approvals and Databases > Drug Trials Snapshots: BAXDELA

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A new DRUG TRIALS SNAPSHOT is now available.
BAXDELA is an antibacterial medicine used to treat adult patients with bacterial skin infections known as acute bacterial skin and skin structure infections (ABSSSI) caused by certain bacteria.
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov






Drug Trials Snapshots: BAXDELA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the BAXDELA Prescribing Information for complete information.
BAXDELA (delafloxacin) 
(Bax-de’-lah)
Melinta Therapeutics, Inc.
Approval date: June 19, 2017

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

BAXDELA is an antibacterial medicine used to treat adult patients with bacterial skin infections known as acute bacterial skin and skin structure infections (ABSSSI) caused by certain bacteria.

How is this drug used?

BAXDELA is given by a healthcare professional using a needle placed in a vein (known as intravenous or IV infusion) over 60 minutes two times a day. BAXDELA can also be taken as a tablet two times a day for 5 to 14 days.

What are the benefits of this drug?

BAXDELA worked similarly to the standard antibacterial combination therapy of vancomycin and aztreonam in stopping the spread of ABSSSI.

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

  • Sex: BAXDELA worked similarly in men and women.
  • Race: Most of the patients were White. Differences in how well the drug worked among races could not be determined because of the small number of patients in other races.
  • Age: BAXDELA worked similarly in patients above and below age 65.

What are the possible side effects?

BAXDELA like other antibacterial medicines called fluoroquinolones may cause the following serious side effects: tendon rupture, nerve damage (peripheral neuropathy) and certain central nervous system effects.
Serious side effects in patients treated with BAXDELA in clinical trials include allergic reactions and colon infection caused by Clostridium difficile
The most common side effects in patients treated with BAXDELA in clinical trials were nausea, diarrhea, headache, increase in certain liver tests, and vomiting.

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

  • Sex: The occurrence of nausea and diarrhea side effects was similar in men and women.
  • Race: Most of the patients were White. Differences in the occurrence of nausea and diarrhea among races could not be determined because of the small number of patients in other races.
  • Age: The occurrence of nausea and diarrhea side effects was similar in patients above and below age 65.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved BAXDELA based on evidence from two clinical trials of 1510 patients with skin infections. The trials were conducted in the United States, Europe, Latin America and Asia.
Figure 1 summarizes how many men and women were in the clinical trials.
Figure 1. Baseline Demographics by Sex
Pie chart summarizing how many men and women were in the clinical trials. In total, 953 men (63%) and 557 women (37%) participated in the clinical trial.
Clinical trial data
Figure 2 and Table 1 summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 1304 Whites (86%), 77 Black or African Americans  (5%), and 129 Others (9%) participated in the clinical trials.
Clinical trial data
Table 1. Baseline Demographics by Race
Race
Number of Participants
Percentage
White
1304
86
Black or African American
77
5
All Other
129
9
Clinical trial data
Figure 3 summarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age
Pie chart summarizing how many individuals of certain age groups were in the clinical trials.  In total, 1298  patients  were below 65 years old (86%) and 212 were 65 years and older (14%).
Clinical trial data

How were the trials designed?

There were two trials that established the benefits and side effects of BAXDELA. Trials enrolled adult patients with acute bacterial skin and skin structure infections.
In Trial 1, patients were randomly assigned to receive either BAXDELA IV every 12 hours or a comparator ( vancomycin and aztreonam) IV every 12 hours, a treatment regimen that is acceptable therapy for ABSSSI. Neither the patients nor the health care providers knew which injection was being given until after the trial was completed.
In Trial 2, patients started treatment with BAXDELA IV or comparator (vancomycin and aztreonam) IV every 12 hours. After 3 days (total of 6 doses) patients who received BAXDELA IV, continued treatment with BAXDELA tablets (one pill every 12 hours) while patients in the comparator group continued with their IV treatment. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.
The planned treatment duration was 5 to 14 days for both trials.
The benefit of BAXDELA was measured by the proportion of patients who achieved an improvement (reduction in infection lesion size of at least 20%), at 48 to 72 hours after the initiation of the treatments.

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.

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