Next generation strategies for preventing preterm birth

Hannah C Zierden; Rachel L Shapiro; Kevin DeLong; Davell M Carter; Laura M Ensign

doi:10.1016/j.addr.2021.04.021

Next generation strategies for preventing preterm birth

Adv Drug Deliv Rev. 2021 Jul:174:190-209. doi: 10.1016/j.addr.2021.04.021. Epub 2021 Apr 23.

Authors

Hannah C Zierden¹, Rachel L Shapiro¹, Kevin DeLong², Davell M Carter³, Laura M Ensign⁴

Affiliations

¹ Center for Nanomedicine at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Chemical & Biomolecular Engineering, Johns Hopkins University, Baltimore, MD 21218, USA.
² Center for Nanomedicine at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Ophthalmology, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
³ Center for Nanomedicine at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
⁴ Center for Nanomedicine at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Chemical & Biomolecular Engineering, Johns Hopkins University, Baltimore, MD 21218, USA; Department of Ophthalmology, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Departments of Gynecology and Obstetrics, Infectious Diseases, and Oncology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD 21218, USA. Electronic address: lensign@jhmi.edu.

Abstract

Preterm birth (PTB) is defined as delivery before 37 weeks of gestation. Globally, 15 million infants are born prematurely, putting these children at an increased risk of mortality and lifelong health challenges. Currently in the U.S., there is only one FDA approved therapy for the prevention of preterm birth. Makena is an intramuscular progestin injection given to women who have experienced a premature delivery in the past. Recently, however, Makena failed a confirmatory trial, resulting the Center for Drug Evaluation and Research's (CDER) recommendation for the FDA to withdrawal Makena's approval. This recommendation would leave clinicians with no therapeutic options for preventing PTB. Here, we outline recent interdisciplinary efforts involving physicians, pharmacologists, biologists, chemists, and engineers to understand risk factors associated with PTB, to define mechanisms that contribute to PTB, and to develop next generation therapies for preventing PTB. These advances have the potential to better identify women at risk for PTB, prevent the onset of premature labor, and, ultimately, save infant lives.

Keywords: Drug delivery; Nanomedicine; Nanoparticles; Pregnancy; Preterm birth; Vaginal drug delivery.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Review

MeSH terms

17 alpha-Hydroxyprogesterone Caproate / administration & dosage
Animals
Drug Approval
Drug Development*
Female
Humans
Infant, Newborn
Pregnancy
Premature Birth / etiology
Premature Birth / physiopathology
Premature Birth / prevention & control*
Progestins / administration & dosage
Risk Factors

Substances

Progestins
17 alpha-Hydroxyprogesterone Caproate

Abstract

Publication types

MeSH terms

Substances

Grants and funding