Relief that’s fast and made to last1,2
Relief that’s fast and made to last1,2
Significantly more patients in the clinical trials achieved clinical cure—and sustained it—with BREXAFEMME, compared to placebo.1
0
10
20
30
40
50
60
70
Trial 1 (N=290)
BREXAFEMME
n=95/190
PLACEBO
n=28/100
28%
Trial 2 (N=278)
BREXAFEMME
n=120/189
PLACEBO
n=40/89
45%
Trial 1
BREXAFEMME
n=95/190
Trial 1
PLACEBO
n=28/100
Trial 2
BREXAFEMME
n=120/189
Trial 2
PLACEBO
n=40/89
70
60
50
40
30
20
10
0
28%
45%
Results across all clinical endpoints were achieved without the need for additional antifungal treatment, including topicals.1
*The primary endpoint (test-of-cure) in both trials was clinical cure at Day 10 as defined by a VSS score of 0. Follow-up at Day 25 assessed sustained response. The VSS scale measures a total of 6 domains that include vaginal signs (edema, erythema, excoriation) and symptoms (burning, itching, irritation). Each domain is rated from 0 to 3, with signs assessed by the healthcare provider and symptoms assessed by the patient. Trial inclusion criteria for composite VSS was a minimum score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater. Median VSS score at baseline was 9 (range 4-18) in VANISH 303 and 10 (range 4-18) in VANISH 306.1,2
†In both clinical studies, a secondary endpoint of sustained resolution of VVC signs and symptoms was assessed at Day 25 follow-up. Symptom resolution was defined as the absence of all symptoms (VSS score=0) at Day 25 follow-up.1,2
‡At Day 10, 50% vs 28% and 64% vs 45% (BREXAFEMME vs placebo) of patients achieved complete clinical cure in VANISH 303 and 306, respectively. At Day 25, 60% vs 44% and 73% vs 49% (BREXAFEMME vs placebo) of patients achieved sustained resolution in VANISH 303 and 306, respectively.1
VSS=vulvovaginal signs and symptoms.
Patients treated with BREXAFEMME experienced relief of burning, itching, and irritation.2§
0
10
20
30
40
50
60
70
80
Trial 1 (N=290)
BREXAFEMME
n=113/190
PLACEBO
n=44/100
44%
Trial 2 (N=278)
BREXAFEMME
n=137/189
PLACEBO
n=44/89
49%
Trial 1
BREXAFEMME
n=113/190
Trial 1
PLACEBO
n=44/100
Trial 2
BREXAFEMME
n=137/189
Trial 2
PLACEBO
n=44/89
70
60
50
40
30
20
10
0
44%
49%
Based on patient-recorded symptom diaries, the median time to initial symptom relief was seen as early as Day 2, with median time to complete symptom relief at Day 6.2
§A post-hoc descriptive analysis was performed to better understand patient response in vulvovaginal symptom relief in the VANISH 303 and 306 studies. Daily symptom response data was collected from 376 mITT patients taking BREXAFEMME. Baseline symptom score was completed by the patient and the study investigator in the office setting on Day 1. Patients were given BREXAFEMME 300 mg BID on Day 1 and were then asked to score their symptoms (burning, itching, or irritation) in a diary from Day 2 through the test-of-cure visit on Day 11 (±3 days). The pooled mITT population was assessed for median time to first reduction in any symptom from their baseline symptom score (Day 2; range: 1-15 days. N=376) as well as median time to complete symptom relief (no symptoms [Day 6; range: 1-29 days. N=376]) based on the VANISH patient recorded symptom diaries.2
BID=twice a day; mITT=modified intent to treat; TOC=test of cure.
Explore the study design
The efficacy and safety of BREXAFEMME were evaluated in 2 randomized, multicenter, double-blind, placebo-controlled Phase 3 clinical trials of similar design (VANISH 303 and 306).1
Key Inclusion Criteria
Non-pregnant postmenarchal females with a diagnosis of VVC meeting the following criteria1:
Composite VSS minimum score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater- Positive microscopic exam with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
- Normal vaginal pH (≤4.5)
Treatment
Single day of BREXAFEMME 600 mg (two 150 mg tabs per dose, administered 12 hours apart).1
Primary Endpoint
Percentage of subjects with complete clinical response (VSS score of 0) at Day 10.2
Additional Endpoint
Sustained resolution of VVC signs and symptoms at Day 25.2
SAY NO MORE to vaginal yeast infections.
Prescribe BREXAFEMME today.
SAY NO MORE to vaginal yeast infections. Prescribe BREXAFEMME today.
Indication
BREXAFEMME® is a triterpenoid antifungal indicated for Treatment of VVC and Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in adult and post-menarchal pediatric females.
Important Safety Information
Risk of Embryo-fetal Toxicity
- BREXAFEMME is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies
- For females of reproductive potential, verify that the patient is not pregnant prior to initiating BREXAFEMME treatment. Reassessing pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC)
- Advise females of reproductive potential to use effective contraception during treatment of vulvovaginal candidiasis (VVC) and throughout the 6-month treatment period for reduction in the incidence of RVVC with BREXAFEMME and, for 4 days after the last dose
- BREXAFEMME is contraindicated in patients with a history of hypersensitivity to ibrexafungerp
- When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- Most common adverse reactions observed in clinical trials (incidence ≥2%) of VVC were diarrhea, nausea, abdominal pain, dizziness, and vomiting. Most common adverse reactions observed in a clinical trial of RVVC were headache, abdominal pain, diarrhea, nausea, urinary tract infection and fatigue
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1‑888‑982‑SCYX (1‑888‑982‑7299) or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
- BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
- BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
- When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information and Patient Information.
References
1. BREXAFEMME. Prescribing Information. SCYNEXIS, Inc.; 2021. 2. Data on file. SCYNEXIS, Inc., Jersey City. NJ.
Important Safety Information
Indication
