FP-101 for the Treatment of Hot Flashes in Postmenopausal Women

Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common
symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated
to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This
study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in
post-menopausal women.

Inclusion Criteria:

Subjects may be enrolled in the main study only if they meet all of the following criteria:

- Subject must be a female >40 years of age at screening.

- Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or
50 to 60 hot flashes per week for at least 30 days prior to the Screening Visit of
sufficient severity to cause desire for therapeutic intervention.

- Subject must meet 1 of the following criteria:

- Spontaneous amenorrhea for at least 12 consecutive months.

- Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
(FSH ≥40 mIU/mL).

- Bilateral oophorectomy or salpingo-oophorectomy ≥6 weeks prior to enrollment with
or without hysterectomy.

- A subject who is not at least 2 years postmenopausal must use adequate nonhormonal
contraception (eg, barrier methods such as an intrauterine device, diaphragm, cervical
cap, or condom) during study participation.

- Subject must be willing and able to be compliant with the protocol and provide a
voluntary written informed consent.

Exclusion Criteria:

- Subject has a history of hypersensitivity or adverse reaction to FP-101 or its
excipients

- Subject is a known non-responder to previous SSRI or SNRI treatment for VMS

- Subject has a history of self-injurious behavior.

- Subject has a lifetime history of a clinical diagnosis of major depression or
treatment for major depressive disorder.

- Subject has a history of clinical diagnosis of borderline personality disorder.

- Subject has a history of, or is currently presenting with, substance use disorder as
defined by the 5th Edition of the Diagnostic and Statistical Manual (DSM-5).

- Subject has a history of psychiatric disorders, including a lifetime history of major
depressive disorder, bipolar disorder, panic disorder, generalized anxiety, psychotic
disorders, suicidality or suicidal ideation, or post-traumatic stress disorder.

- Subject has a history of hypertension and is not on a stable dose of antihypertensive
medications for at least 30 days prior to screening.

- Subject is currently taking MAOIs, thioridazine, or pimozide.

- Subject is currently taking tamoxifen, other selective estrogen receptor modulators,
or other hormone deprivation therapy.

- Subject exhibits evidence of impaired liver function upon entry into the study (values
≥2 times the upper limit of normal for aspartate transaminase and/or alanine
transaminase, or serum bilirubin ≥1.3 mg/dL) or, in the Investigator's opinion,
exhibits liver function impairment to the extent that the subject should not
participate in the study.

- Subject has clinically unstable cardiac disease, including unstable atrial
fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active
myocardial ischemia.

- Subject exhibits evidence of impaired kidney function upon entry into the study (i.e.,
serum creatinine >1.5 mg/dL) or known renal stricture.

- Subject has biliary tract disease, adrenal cortical insufficiency, or any other
medical condition that, in the Investigator's opinion, is inadequately treated and
precludes entry into the study.

- Subject has thyroid disease, unless subject is clinically stable with normal thyroid
indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine)
for ≥6 months prior to screening.

- Subject exhibits a positive urine pregnancy test result at screening or at any time
during study