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The proven power of a BOLD attack

BREXAFEMME delivered complete and sustained resolution of VVC signs and symptoms1

Significantly more patients in the BREXAFEMME group achieved complete resolution of VVC signs and symptoms at Day 10 and sustained resolution at Day 25.



Superior versus placebo in completely resolving
signs and symptoms of VVC at Day 10*

COMPLETE RESOLUTION AT DAY 10*

0

10

20

30

40

50

60

70

Trial 1 (N=290)

BREXAFEMME
n=95/190

percentage

PLACEBO
n=28/100

28%

Trial 2 (N=278)

BREXAFEMME
n=120/189

percentage

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

percentage

28%

percentage

45%

Proven to deliver lasting response1

SUSTAINED RESOLUTION AT DAY 25

SUSTAINED RESOLUTION AT
DAY 25

0

10

20

30

40

50

60

70

80

Trial 1 (N=290)

BREXAFEMME
n=113/190

percentage

PLACEBO
n=44/100

44%

Trial 2 (N=278)

BREXAFEMME
n=137/189

percentage

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

percentage

44%

percentage

49%

Results 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 vaginal signs and symptoms score (VSS) 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. Study 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 Trial 1 and 10 (range 4-18) in Trial 2.1

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 (burning, itching, irritation) (VSS score=0) without need for further antifungal treatment or topical vaginal drug therapy for the treatment of vulvovaginal symptoms prior to or at Day 25 follow-up.1,6,7

Indication

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).

Important Safety Information

  • 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. Scynexis, Inc. Updated June 2, 2021. Accessed July 2, 2021. https://www.scynexis.com/news-media/press-releases/detail/240/scynexis-announces-fda-approval-of-brexafemme. 3. Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the management of candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infec Dis. 2016;62(4):e1–50. 4. Gintjee TJ, Donnelley MA, Thompson GR 3 rd . Aspiring antifungal: review of current antifungal pipeline developments. J Fungi (Basel). 2020:6(1):28 doi:10.3390/jof601028. 5. Data on file [1]. SCYNEXIS, Inc., Jersey City, NJ. 6. Data on file [2]. SCYNEXIS, Inc., Jersey City, NJ. 7. Data on file [3]. SCYNEXIS, Inc., Jersey City. NJ. 8. Data on file [4]. SCYNEXIS, Inc., Jersey City. NJ.

Important Safety Information

Indication

  • 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.

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).