Drugs

Drug Trials Snapshots: MOXIDECTIN

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 MOXIDECTIN Package Insert for complete information.

MOXIDECTIN
mox-i-dectin
Medicines Development for Global Health
Approval date: June 13, 2018


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

MOXIDECTIN is a drug used for the treatment of onchocerciasis in patients 12 years of age and older.

Onchocerciasis (river blindness) is an eye and skin disease which is spread by the bite of a fly that is infected with a worm called Onchocerca volvulus.

How is this drug used?

MOXIDECTIN is administered as a single dose of 4 tablets taken by mouth.

What are the benefits of this drug?

Patients treated with MOXIDECTIN had fewer detectable worms in the skin when compared to patients treated with comparator drug ivermectin.

What are the benefits of this drug (results of trials used to assess efficacy)?

The table below summarizes efficacy results for Trial NCT00790998 based on the Intent-to-Treat (ITT) population.

Table 2. Mean Microfilarial Density and Percentage of Undetectable Microfilariae in Skin of O. volvulus Patients (12 Years of Age and Older) at Months 1, 6, and 12 in Trial NCT00790998

EndpointMOXIDECTIN
N = 977
Ivermectin
N = 495
Difference
(95% Confidence Interval)
1 month
Mean Microfilarial Density0.102.30-2.20 (-2.83, -1.58)
p < 0.0001
% Undetectable Microfilariae83.4%42.9%40.5% (35.7, 45.3)
p < 0.0001
6 months
Mean Microfilarial Density0.143.71-3.57(-4.11, -3.03)
p < 0.0001
% Undetectable Microfilariae91.0%11.5%79.6% (76.3, 82.9)
p < 0.0001
12 months
Mean Microfilarial Density1.799.83-8.04 (-9.11, -6.98)
p < 0.0001
% Undetectable Microfilariae45.9%5.4%40.4% (36.7, 44.1)
p < 0.0001

Microfilarial density is microfilariae count/mg skin. Mean microfilarial density in skin is the average microfilarial density over skin snips from four sites.
#Proportion of subjects undetectable (defined as a mean skin microfilariae density of zero across all 4 skin snips).

MOXIDECTIN Prescribing Information

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

  • Sex: MOXIDECTIN worked similarly in males and females.
  • Race: All patients were Black. Therefore, differences among races could not be determined.
  • Age: MOXIDECTIN worked similarly in patients 12 to 18 years of age and those older than 18 years of age.

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

Table 3 below summarizes the results for the primary efficacy endpoint, mean microfilarial density, by sex and age in Trial NCT00790998.

Table 3. 12 Month Mean MFa Density Within Subgroups of Intent-to-Treat (ITT) Population

VariableSubgroupNb
NM/NI
Overall BaselineMOXIDECTINIvermectinDifference
Sexc
 Female531
352/179
37.710.558.35-7.80
(-9.42, -6.19)
P< .0001
 Male941
625/316
40.552.5410.56
 
-8.02
(-9.44, -6.59)
P< .0001
Age Groupd
 Adolescent
12 to < 18 years
77
53/24
28.622.9411.48-8.54
(-13.79, -3.29)
P = .0014
 Adult
> 18 years
1395
924/471
40.131.739.73-8.01
(-9.11, -6.90)
P< .0001

a MF= microfilarial
b Nm= number of participants in the MOXIDECTIN arm
NI= number of participants in ivermectin arm
c Sex differences in efficacy are not significant p> 0.8.
d Age group differences in efficacy are not significant, p>0.8.

FDA Review

What are the possible side effects?

MOXIDECTIN may cause serious side effects including decrease in blood pressure when standing, worsening of the disease, and a type of severe allergic reaction called Mazzotti reaction.

The most common side effects are increase in type of white blood cells called eosinophils, itching, muscle or bone pain, and headache.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions, in patients with onchocerciasis, who received at least one dose of MOXIDECTIN.

Table 4. Adverse Reactions Occurring in > 10% of Moxidectin-treated Patients with Onchocerciasis in Trial NCT00790998

Adverse ReactionMOXIDECTIN
N = 978
n (%)
Ivermectin
N = 494
n (%)
Eosinophilia721 (74)390 (79)
Pruritus640 (65)268 (54)
Musculoskeletal paina623 (64)257 (52)
Headache566 (58)267 (54)
Lymphocytopenia*470 (48)215 (44)
Tachycardiab382 (39)148(30)
Orthostatic tachycardiac333 (34)130 (26)
Non-orthostatic tachycardiad179 (18)57 (12)
Rashe358 (37)103 (21)
Abdominal painf305 (31)173 (35)
Hypotensiong289 (30)125 (25)
Orthostatic hypotensionh212 (22)81 (16)
Pyrexia/Chills268 (27)88 (18)
Leukocytosis240 (25)125 (25)
Influenza like illness226 (23)102 (21)
Neutropenia**197 (20)112 (23)
Cough168 (17)88 (18)
Lymph node pain129 (13)28 (6)
Dizziness121 (12)44 (9)
Diarrhea/Gastroenteritis/Enteritis144 (15)84 (17)
Hyponatremia112 (12)65 (13)
Peripheral swelling107 (11)30 (6)

aIncludes “myalgia”, “arthralgia”, “musculoskeletal pain”, “pain” and “back pain”
bIncludes “orthostatic heart rate increased”, “postural orthostatic tachycardia syndrome”, “heart rate increased” and “sinus tachycardia”
cIncludes “orthostatic heart rate increased” and “postural orthostatic tachycardia syndrome”
dIncludes “heart rate increased”, “tachycardia”, and “sinus tachycardia”
eIncludes “rash,” “papular rash” and “urticaria”
fIncludes “abdominal pain”, “abdominal pain upper” and “abdominal pain lower”
gIncludes “orthostatic hypotension”, “blood pressure orthostatic decreased”, “blood pressure decreased”, “mean arterial pressure decreased”, “hypotension”
hIncludes “orthostatic hypotension”, and “blood pressure orthostatic decreased”
*Lymphocytopenia is defined as absolute lymphocyte count less than 1 x 109/L
**Neutropenia is defined as absolute neutrophil count less than 1 x 109/L

MOXIDECTIN Prescribing Information

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

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: All patients were Black. Therefore, differences among races could not be determined.
  • Age: The occurrence of side effects was similar in patients younger and older than 18 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The tables below summarize the occurrence of the two most frequent adverse reactions by subgroup for the safety population.

Table 5. Pooled Subgroup Analysis of Eosinophilia (safety population)

Demographic CharacteristicMOXIDECTIN
n/N (%)
Ivermectin
 n/N (%)
Sex
Male460/626) (73.5)244/315 (77.5)
Female261/352 (74.1)146/179 (81.6)
Age Group
12 to < 18 years32/53 (60.4)14/24 (58.3)
> 18 years689/925 (74.5)376/470 (80.0)

Clinical Trial Data

Table 6. Pooled Subgroup Analysis of Pruritus (safety population)

Demographic CharacteristicMOXIDECTIN
n/N (%)
Ivermectin
 n/N (%)
Sex
Male402/626) (64.2)165/315 (52.4)
Female238/352 (67.6)103/179 (57.5)
Age Group
12 to < 18 years34/53 (64.2)10/24 (41.7)
> 18 years606/925 (65.5)258/470 (54.9)

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved MOXIDECTIN based primarily on evidence from a clinical trial (NCT00790998) of 1472 patients with onchocerciasis. The trial was conducted at 4 sites in West Africa.

Figure 1 summarizes how many males and females participated in the trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many males and females were in the clinical trials. In total, 941 males (64%) and 531 (36%) females participated in the clinical trials.

FDA Review

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

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trials. In total, 1472 (100%) participated in the clinical trials.

FDA Review

Table 1. Demographics of Clinical Trial by Race

RaceNumber of PatientsPercentage
Black1472100%

FDA Review

Figure 3 summarizes the percentage of patients, in the clinical trial, by age.

Figure 3. Baseline Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trials. In total, 77 patients (5%) were 12 to less than 18 years old, and 1395 patients (95%) were 18 years and older.

FDA Review

Who participated in the trials?

The table blow summarizes demographics of all patients in the clinical trial.

Table 7. Demographic Characteristics of Patients in the Clinical Trial

Baseline CharacteristicsMOXIDECTIN
N=978
n (%)
Ivermectin
N=494
n (%)
Total
N=1472
n (%)
Sex
Male626 (64.0)315 (63.8)941 (63.9)
Female352 (36.0)179 (36.2)531 (36.1)
Race
Black978 (100.0)494 (100.0)1472 (100.0)
Age
Mean years (SD)41.6 (16.4)42.9 (16.1)42.3 (16.2)
Median (years)424443
Min, max (years)12, 9512, 8612, 95
Age Group
12 to < 18 years53 (5.4)24 (4.9)77 (5.2)
> 18 to < 65 years842 (86.1)420 (85.0)1262 (85.7)
> 65 years83 (8.5)50 (10.1)133 (9.1)
Region
West Africa978 (100.0)494 (100.0)1472 (100.0)
Ethnicity
Non-Hispanic978 (100.0)494 (100.0)1472 (100.0)

FDA Review

How were the trials designed?

The benefit and side effects of MOXIDECTIN were primarily evaluated in one clinical trial in patients with onchocerciasis. Patients were randomly assigned to receive a single dose of MOXIDECTIN or ivermectin, the only FDA approved treatment for onchocerciasis. The benefit of MOXIDECTIN was assessed twelve months after treatment by measuring the amount of the worms in the skin of patients treated with MOXIDECTIN and comparing it to the amount of the worms in the skin of patients treated with ivermectin.

How were the trials designed?

The efficacy and safety of MOXIDECTIN were primarily evaluated in one clinical trial, in patients 12 years or older, with onchocerciasis. Trial (NCT00790998) evaluated MOXIDECTIN 8 mg single dose compared with ivermectin. The primary endpoint was the mean skin microfilarial density (microfilariae/mg skin) at 12 months post-treatment. The mean microfilarial density was assessed from the mean of 4 skin snips per person.

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.

PRESCRIBING INFORMATION

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Page Last Updated: 07/09/2018
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