Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia

This is a blinded, randomized, placebo-controlled study. All subjects who meet the inclusion
requirements and no exclusion criteria will be entered into an up to 14 day screening phase.
Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days
0 and 5. All treated subjects will be followed for efficacy and safety for 42 days. Subjects
will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. The
subject's participation in the study will be for approximately 42 days from day 0.

Inclusion Criteria:

- Male or female subject's ≥ 18 years of age, able to give informed consent to the
study.

- Fibromyalgia diagnosis based on The 2011 modification of the American College of
Rheumatology (ACR) 's 2010 preliminary criteria for diagnosing fibromyalgia
(2011ModCr)

- A baseline score ≥ 60 on the FIQR

- Subject's current medications to treat fibromyalgia, including pain medicines,
anti-depressants, sleep medications must be on a stable dose for at least 30 days.

- Subject's current narcotic medication must be on a stable dose for at least 30 days
prior to randomization

- Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be
practicing an acceptable form of birth control: have had a hysterectomy or tubal
ligation, or otherwise be incapable of pregnancy, or have practiced any of the
following methods of contraception for at least one month prior to study entry:
hormonal contraceptives, spermicide and barrier, intrauterine device, partner
sterility.

Exclusion Criteria:

- Parenteral iron use within 4 weeks prior to screening.

- History of > 10 blood transfusions in the past 2 years.

- Anticipated need for blood transfusion during the study.

- Known hypersensitivity reaction to any component of Injectafer® (Ferric
Carboxymaltose).

- Current or acute or chronic infection other than viral upper respiratory tract
infection

- Malignancy (other than basal or squamous cell skin cancer or the subject has been
cancer free for ≥ 5 years).

- Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).

- Pregnant or lactating women.

- Severe peripheral vascular disease with significant skin changes.

- Seizure disorder currently being treated with medication.

- Baseline ferritin ≥ 50 ng/mL.

- Baseline TSAT ≥ 20%.

- History of hemochromatosis or hemosiderosis or other iron storage disorders.

- Known positive hepatitis with evidence of active disease.

- Hemoglobin greater than the upper limit of normal.

- Calcium or phosphorous outside the normal range.

- Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with
evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).

- Known positive HIV-1/HIV-2 antibodies (anti-HIV)

- Received an investigational drug within 30 days before randomization.

- Chronic alcohol or drug abuse within the past 6 months.

- Any other pre-existing laboratory abnormality, medical condition or disease which in
view of the investigator participation in this study may put the subject at risk.

- Subject unable to comply with the study requirements.