A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV)
sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult
patients undergoing diagnostic or therapeutic procedures.1 It is a water-soluble,
phosphono-O-methyl prodrug of propofol. Upon IV injection, the inactive fospropofol
undergoes metabolism, most notably by alkaline phosphatase enzymes, to yield the active
metabolite (propofol), phosphate, and formaldehyde. Formaldehyde is quickly converted to
formate in vivo, and formate is further metabolized by a folate-dependent mechanism.

Inclusions:

- Lactating women undergoing a needed procedure expected to last between approximately
10 to 45 minutes

- Subjects should be between 6 weeks and 8 months postpartum

- Lactation must be well-established in subjects

- Subject's infants must be full term and able to bottle-feed

- Infants should be predominantly breast milk fed and should not receive more than one
bottle of formula per day

Exclusions:

- Subjects who are pregnant

- Subjects undergoing a breast procedure (eg, biopsy, abscess drainage, etc.)

- Subjects who are not willing to temporarily refrain from nursing their children
during the 0-24 hour breast milk collection interval.

(Subjects may resume nursing following this interval).