Pediatric Drug Reformulation

Children represent 25% of the American population, yet only 6% of healthcare dollars in the U.S. are spent on pediatric patients. Because of the small market size, innovations designed specifically for children are less profitable to drug manufacturers. Many medications needed by sick kids are never made in pediatric formulations. As a result, pediatric patients are exposed to a greater risk of adverse events, less than optimal treatment or no treatment at all. IPI is working to reformulate drugs in for pediatric-appropriate dosage and administration. 

Epaned (TM)

Silvergate Pharmaceuticals estimates that over 20,000 patients have been prescribed Epaned(TM) since IPI licensed the pediatric formulation to the company. EpanedTM is now stocked in over 300 hospitals and as been dispensed by over 400 pharmacies. Following this success, IPI is now researching additional needs for new pediatric formulations, with the principal focus on health needs in the developing world. 


Global Alliance for Pediatric Therapeutics

Over the last several years, IPI has been bringing together pharmaceutical companies, hospital and medical school specialists, government agencies, and parents and children through a pre-competitive framework called the Global Alliance for Pediatric Therapeutics (GAPT).

In 2014 the Alliance partners studied the challenges and practices of obtaining assent of pediatric patients enrolled in clinical trials, as required by the FDA and European Medicines Agency, as its focus. More than 100 organizations participated in a survey of current practices, including participants in Europe, Japan, and Korea. The results have been compiled and a draft for publication is pending. Previously, the Alliance studied tools and practices for determining palatability of pediatric drug formulations.

GAPT is also looking for partners to reformulate medications for pediatric HIV adherence. Learn more about that initiative here.