The Sponsor was developing a therapy that could be administered to women undergoing childbirth via Caesarean section. Since the drug would have no benefit to the infant, the Sponsor was required to evaluate how much of the drug formulation could be passed to the infant through breast milk. Lactation studies are typically conducted after the development of mature milk and once the drug is at steady state after chronic dosing. Since the drug would only be administered as a single dose following childbirth, neither of those options were applicable.
Nuventra and the Sponsor collaborated to design a study in which mothers would agree to solely use a breast pump (foregoing nursing the baby) and collect all milk produced through at least 2 weeks after childbirth. While the drug effect was expected to last only a few days, it was important to capture the full pharmacokinetic (PK) profile of the drug formulation in maternal plasma and breast milk as a surrogate for infant exposure. Both maternal plasma and breast milk were collected and analyzed to evaluate the PK profiles in both matrices, as well as to get a milk/plasma ratio.
The FDA reviewed & approved the protocol before dosing the first patient. More than 12 women have completed the ongoing study and early results indicate the study objectives can be met.