A new DRUG TRIALS SNAPSHOT is now available.
XADAGO is a drug for the treatment of “off episodes” in patients with Parkinson’s disease (PD). XADAGO is to be added to drugs for the treatment of Parkinson’s disease that contain levodopa/carbidopa combination.
An “off” episode” is a time when a patient’s medications are not working well, leading to an increase in Parkinson’s symptoms, such as tremor and difficulty walking.
See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
XADAGO (safinamide)
(ZA-da-go)
Newron Pharmaceuticals
Approval date: March 21, 2017
(ZA-da-go)
Newron Pharmaceuticals
Approval date: March 21, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
XADAGO is a drug for the treatment of “off episodes” in patients with Parkinson’s disease (PD). XADAGO is to be added to drugs for the treatment of Parkinson’s disease that contain levodopa/carbidopa combination.
An “off” episode” is a time when a patient’s medications are not working well, leading to an increase in Parkinson’s symptoms, such as tremor and difficulty walking.
How is this drug used?
XADAGO is a tablet taken by mouth once a day.
What are the benefits of this drug?
On average, patients taking XADAGO experienced more “ON” time, a time when Parkinson’s symptoms are reduced, without troublesome involuntary movement (dyskinesia), compared to those receiving a placebo.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: XADAGO worked similarly in men and women.
- Race: XADAGO worked similarly in White and Asian patients. The number of patients of other races was limited; therefore, differences in response could not be determined.
- Age: XADAGO worked similarly in patients above and below age 65.
What are the possible side effects?
When taken with certain other medications, XADAGO may cause a serious, life- threatening condition called serotonin syndrome. Other serious side effects include an increase in blood pressure, falling asleep during activities of daily living (watching television, driving a car, etc.), hallucinations (seeing or hearing things that are not real), behavioral problems, and confusion.
The most common side effects are uncontrolled involuntary movements (dyskinesia), fall, nausea, and difficulty sleeping.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of some side effects was higher in women than in men.
- Race: The occurrence of side effects was similar between White and Asian patients. The number of patients in other races was limited; therefore, differences in side effects among other races could not be determined.
- Age: The occurrence of 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 XADAGO based on evidence from two clinical trials of 1218 patients with PD whose symptoms were not well controlled while receiving their regular PD treatment. The trials were conducted in 178 centers in North America, Europe, Asia and Latin America.
Figure 1 summarizes how many men and women were enrolled in the clinical trials.
Figure 1. Baseline Demographics by Sex
Clinical trial data
Figure 2 summarizes the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
Clinical trial data
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| Asian | 712 | 59 |
| White | 501 | 41 |
| Black or African American | 5 | less than 1 |
Clinical trial data
Figure 3 summarizes the percentage of patients by age that were enrolled in the clinical trials.
Figure 3. Baseline Demographics by Age
Clinical trial data
How were the trials designed?
There were two 24-week trials conducted in PD patients with inadequate control of their Parkinson’s symptom (“OFF” time) while receiving carbidopa/levodopa and other PD medications. Patients were randomly selected to receive either XADAGO or placebo pill once a day for 24 weeks. Neither the patients nor the health care providers knew which new treatment was being given until the trial was completed 24 weeks later.
In both trials, the benefit was evaluated by measuring the change from baseline in total daily “ON” time in XADAGO and placebo receiving patients. “ON” time was defined as time without any dyskinesia plus the time with non-troublesome dyskinesia and was based on the 18-hour diaries completed by patients for at least 3 days before each of the scheduled visits.
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.
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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