Drug Trials Snapshot: SOLOSEC
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 SOLOSEC Prescribing Information for complete information.
SOLOSEC (secnidazole)
(soe’loe sek)
Symbiomix Therapeutics
Approval date: September 15, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
SOLOSEC is used to treat adult women with vaginal infections caused by bacteria known as bacterial vaginosis.
How is this drug used?
SOLOSEC is taken once in the form of granules sprinkled on soft food.
What are the benefits of this drug?
In one trial, 68% of the patients who received SOLOSEC cured bacterial vaginosis in comparison to 18% of those who received placebo.
In the second trial, 53% of the patients who received SOLOSEC cured bacterial vaginosis in comparison to 19% of those who received placebo.
What are the benefits of this drug (results of trials used to assess efficacy)?
The determination of efficacy of SOLOSEC was based on the proportion of patients who were Clinical Responders in Trials 1 and 2. Clinical Responder was defined as a patient with “normal” vaginal discharge, negative “whiff” test, and clue cells <20% at="" 21-30="" days="" post="" treatment.="" nugent="" score="" cure="" (nugent="" score="" of="" 0="" -3)="" and="" therapeutic="" outcome="" were="" also="" assessed. ="" a="" therapeutic="" responder="" was="" defined="" as="" a="" clinical="" responder="" with="" a="" nugent="" score="">
Table 2. Efficacy of SOLOSEC for Treatment of Bacterial Vaginosis in Two Randomized, Double-Blind, Placebo-Controlled Studies in Modified-Intent-to-Treat Population at 21-30 Days
| Trial 1 | Trial 2 | |||
|---|---|---|---|---|
| SOLOSEC (N=62) a n (%) |
Placebo (N=62) a n (%) |
SOLOSEC (N=107) a n (%) |
Placebo (N=57) a n (%) |
|
| Clinical Responderb | 42 (67.7) | 11 (17.7) | 57 (53.3) | 11 (19.3) |
| 50.0 (33.4, 66.7)d p<> |
34.0 (18.7, 49.3)d p<> |
|||
| Nugent Score Curec | 25 (40.3) | 4 (6.5) | 47 (43.9) | 3 (5.3) |
| 33.8 (18.5, 49.1)d p<> |
38.6 (26.2, 51.0)d p<> |
|||
| Therapeutic Responder | 25 (40.3) | 4 (6.5) | 37 (34.6) | 2 (3.5) |
| 33.8 (18.5, 49.1)d p<> |
31.1 (19.6, 42.6)d p<> |
|||
aN=number of patients in treatment group (modified intent-to-treat population defined as all patients randomized who had a baseline Nugent score ≥4 and were negative for other sexually transmitted infections at baseline).
bPatients missing one or more of the clinical assessments were considered as non-responders/not cured.
cPatients with missing Nugent scores were considered Nugent score failures.
dDifference in response (SOLOSEC – placebo) and 95% confidence interval
SOLOSEC Prescribing Information
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
Because the patients were adult women less than 65 years of age, sex and age based analyses were not conducted. SOLOSEC worked similarly in White and Black or African American patients.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Subgroup analysis by race for each trial is presented below based on Clinical Responder endpoint. Since all the patients were women of adult age and none were older than 65 years, analyses by sex and age were not conducted.
Table 3. Clinical Responder by Race –Trial 1 -mITT Population
| SOLOSEC (N=62) | Placebo (N=62) | Difference (95% CI) | |
|---|---|---|---|
| Black or African American | 15/26 (57.7) | 2/34 (5.9) | 51.8 (27.8,75.8) |
| White | 24/32 (75) | 9/24 (37.5) | 37.5 (9.4, 65.6) |
| Other | 3/4 | 0/4 |
Adapted from FDA Statistical review
Table 4. Clinical Responder by Race –Trial 2 -mITT Population
| SOLOSEC (N=107) |
Placebo (N=57) |
Difference (95% CI) |
|
|---|---|---|---|
| Black or African American | 27/59 (45.8) | 6/29 (20.7) | 25.2 (3.1, 47.1) |
| White | 29/46 (63) | 5/26 (19.2) | 43.8 (20.2, 67.4) |
| Other | 1/2 | 0/2 |
Adapted from FDA Statistical review
What are the possible side effects?
Common side effects include vaginal yeast infection, headache, nausea, vomiting, metallic taste in the mouth, diarrhea, abdominal pain and vaginal itching.
What are the possible side effects (results of trials used to assess safety)?
Table 5 summarizes the most common adverse events observed in the trials.
Table 5. Adverse Reactions Occurring in ≥ 2 % SOLOSEC –Treated Patients (Pooled Placebo-Controlled Trials 1 and 2 in Adult Women with Bacterial Vaginosis)
| Adverse Reaction | Trials 1 and 2 | |
|---|---|---|
| SOLOSEC | Placebo | |
| N=197 n (%) |
N=136 n (%) |
|
| Vulvo-vaginal candidiasis | 19 (9.6) | 4 (2.9) |
| Headache | 7 (3.6) | 2 (1.5) |
| Nausea | 7 (3.6) | 1 (0.7) |
| Diarrhea | 5 (2.5) | 1 (0.7) |
| Abdominal pain | 4 (2.0) | 2 (1.5) |
| Vulvovaginal pruritus | 4 (2.0) | 2 (1.5) |
SOLOSEC Prescribing Information
Were there any differences in side effects among sex, race and age?
Because all the patients were adult women less than 65 years of age, sex and age based analyses were not conducted. The occurrence of common side effects was similar in the White and Black or African America patients.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
The table below summarizes the incidence of the most common adverse reactions by race. Since all the patients were women of adult age and none were older than 65 years, analyses by sex and age were not conducted.
Table 6. Adverse Reactions Occurring in > 2% of Patients Receiving SOLOSEC by Race – Safety Population in Combined Trials 1 and 2
| Black or African American | All Other | |||
|---|---|---|---|---|
| SOLOSEC | Placebo | SOLOSEC | Placebo | |
| N | 95 | 72 | 102 | 64 |
| Any, n (%) | 25 (26.3) | 11 (15.3) | 32 (31.4) | 10 (15.6) |
| Vulvovaginal mycotic infection | 8 (8.4) | 3 (4.2) | 3 (2.9) | 0 |
| Headache | 3 (3.2) | 2 (2.8) | 4 (3.9) | 0 |
| Vulvovaginal candidiasis | 3 (3.2) | 1 (1.4) | 5 (4.0) | 0 |
| Nausea | 5 (5.3) | 0 | 2 (2.0) | 1 (1.6) |
| Abdominal pain | 3 (3.2) | 1 (1.4) | 1 (1.0) | 1 (1.6) |
| Diarrhea | 3 (3.2) | 0 | 2 (2.0) | 1 (1.6) |
| Vulvovaginal pruritus | 2 (2.1) | 1 (1.4) | 2 (2.0) | 1 (1.6) |
Clinical trial report
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
FDA approved SOLOSEC based primarily on the results of 333 women with bacterial vaginal infections from two clinical trials conducted in the United Sates. These patients are presented in the Figures 1-3 below.
The FDA also considered data from 321 patients with bacterial vaginal infections who received SOLOSEC in Trial 3. These patients are presented in Table 8 under MORE INFO.
Figure 1 summarizes patients by sex who were in the Clinical Trials 1 and 2.
Figure 1. Baseline Demographics by Sex SOLOSEC
FDA Clinical review
Figure 2 and Table 1 summarize the percentage of patients by race in Clinical Trials 1 and 2.
Figure 2. Baseline Demographics by Race SOLOSEC
FDA Clinical review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage (%) |
|---|---|---|
| Black or African American | 167 | 50 |
| White | 152 | 46 |
| Asian | 5 | 1 |
| Other | 7 | 2 |
| Native Hawaiian or other Pacific Islander | 1 | less than 1 |
| American Indian or Alaska Native | 1 | less than 1 |
FDA Clinical review
Figure 3 summarizes by age how many patients were in Clinical Trials 1 and 2.
Figure 3. Baseline Demographics by Age
FDA Clinical review
Who participated in the trials?
The table below summarizes baseline demographic information for population from combined trials 1 and 2.
Table 7. Demographic Characteristics of Patients in Combined Trials 1 and 2
| SOLOSEC N=197 n(%) |
PLACEBO N=136 n(%) |
Total N=333 n(%) |
|
|---|---|---|---|
| Sex | |||
| Women | 197(100) | 136 (100) | 333 (100) |
| Race | |||
| Black or African American | 95 ( 48.2) | 72 ( 52.9) | 167 (50.1) |
| White | 95 ( 48.2) | 57 ( 41.9) | 152 (45.6) |
| Asian | 2 ( 1) | 3 ( 2.2) | 5 (1.5) |
| Native Hawaiian or other Pacific Islander | 0 ( 0.0) | 1 ( 0.7) | 1(0.3) |
| American Indian or Alaska Native | 1 ( 0.5) | 0 ( 0.0) | 1(0.3) |
| Other | 4 (2) | 3 (2.2) | 7 (2.1) |
| Age (years) | |||
| Median | 31 | 32 | 31 |
| Min, Max | 18,54 | 18,49 | 18,54 |
| Ethnicity | |||
| Hispanic or Latino | 29 ( 14.7) | 20 ( 14.7) | 49 (14.7) |
| Not Hispanic or Latino | 168 ( 85.3) | 116 ( 85.3) | 284 (85.3) |
Clinical trial data
Table 8. Demographic Characteristics of Patients in Trial 3
| Total N=321 n(%) |
|
|---|---|
| Sex | |
| Women | 321(100) |
| Race | |
| Black or African American | 148 (46.1) |
| White | 165 (51.4) |
| Asian | 2 (0.6) |
| Native Hawaiian or other Pacific Islander | 1(0.3) |
| American Indian or Alaska Native | 2 (0.6) |
| Other | 3 (0.9) |
| Age (years) | |
| Median | 30 |
| Min, Max | 15,53 |
| Ethnicity | |
| Hispanic or Latino | 72 (22.4) |
| Not Hispanic or Latino | 249 (77.6) |
FDA Clinical review
How were the trials designed?
In Clinical Trials 1 and 2, patients randomly received either one time SOLOSEC or placebo granules. Neither the patients nor the health care professionals knew which treatment was given until after the study was complete.
The benefit of SOLOSEC was measured by the proportion of patients who were cured and compared it to placebo. The benefit was assessed 21 to 30 days after the drug administration and the side effects were collected up to that time.
In Clinical Trial 3, all patients received one time SOLOSEC granules. Patients were evaluated primarily for side effects.
How were the trials designed?
There were two multicenter, randomized, placebo-controlled trials designed to evaluate the safety and efficacy of single dose SOLOSEC in adult women with bacterial vaginosis.
The efficacy of SOLOSEC in both trials was assessed at 21-30 days post-treatment and compared to placebo. The primary efficacy endpoint was Clinical Responder, defined as a patient with normal vaginal discharge, a negative Whiff test, and clue cells <>
Trial 3 was an open-label, single arm safety trial of single dose SOLOSEC for the treatment of women with bacterial vaginosis.
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.