PTN meropenem study published in the Federal Register

The PTN marks another milestone as the Food and Drug Administration (FDA) has published a summary report of its pediatric study of meropenem in the Federal Register.

Meropenem is a broad-spectrum anti-microbial drug often used to treat intra-abdominal infections in infants. The purpose of the PTN study, which began in the summer of 2008, was to determine the optimal dosing regimen for meropenem in infants younger than 90 days old. Researchers were also interested in determining how safe the drug is for very young infants, especially when compared with imipenem, another broad-spectrum anti-microbial drug closely related to meropenem.

The trial included 200 infants at 24 neonatal intensive care units across the United States. Findings suggested that meropenem as dosed in the study is a safe alternative for young infants with intra-abdominal infections. The FDA recently changed the label for meropenem to reflect these findings, which were published in the Pediatric Infectious Disease Journal.

In accordance with the Public Health Service Act, the FDA is making available the labeling changes for meropenem in the Federal Register.

The Institute of Medicine releases report on pediatric studies conducted under BPCA and PREA

The Institute of Medicine (IOM) released a report today that finds that federal laws motivating or requiring drugmakers to conduct pediatric studies have yielded important information to guide the use of medications in children.

Titled “Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act,” the report also notes that studies involving children continue to be limited and suggests avenues to improvement, such as strengthening the design and execution of pediatric studies requested under BPCA or required by PREA, as well as expanding the research scope to include more long-term safety studies and studies in neonates.

The report’s release precedes the 2012 Congressional vote on reauthorization of both BPCA and PREA, which occurs every five years. As directed by Congress, the Food and Drug Administration (FDA) asked the IOM to convene a committee to review aspects of pediatric studies and changes in product labeling that resulted from these legislative acts. Of note, since the two policies were adopted, the FDA has approved 400 labeling changes for drugs used in children.

More information about the IOM report may be found at:

The PTN provides insights and updates at the 2012 BPCA annual meeting

On December 4, 2012, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) staged the 2012 Best Pharmaceuticals for Children Act (BPCA) Annual Meeting in Rockville, MD. This yearly event serves as part of the NICHD mandate to oversee a priority list of needs in pediatric therapeutics under the BPCA.

The BPCA priority list identifies key therapeutic needs in the medical treatment of infants, children, and adolescents. The list is organized by therapeutic area, which can be a group of conditions, a specific population, or a setting of care. Each calendar year, a few therapeutic areas are selected for discussion and further prioritization. This year, the NICHD convened expert working groups in dermatology and rheumatology, whose final recommendations will be posted to the BPCA website by the end of the year.

Additionally, meeting participants reviewed the status of the BPCA program and provided updates on currently funded studies. The Pediatric Trials Network (PTN) was a key contributor in this portion of the meeting as it was established by the NICHD to provide an infrastructure for conducting safe and effective pediatric clinical trials for the BPCA drug development program. Michael Cohen-Wolkowiez, a PTN investigator from Duke University, provided an overview of PTN activities and lessons learned in 2012.