Federal regulators are clearing a first-of-its-kind treatment for symptoms of a rare neurodevelopmental disorder that is characterized by insatiable hunger.

The Food and Drug Administration approved a medication this week known as VYKAT XR to treat hyperphagia — or an incessant feeling of hunger — in kids and adults with Prader-Willi syndrome.

The constant desire to eat is a hallmark of Prader-Willi — a genetic condition that affects about 350,000 people worldwide, according to the Prader-Willi Syndrome Association USA — which can lead to obesity and other health issues. Individuals with the condition often experience symptoms starting in infancy, which can include weak muscle tone, difficulty with sucking, swallowing and other physical issues as well as learning difficulties, developmental delays and behavior problems.

“The FDA approval of VYKAT XR is an incredible achievement for the entire PWS community,” said Dr. Jennifer Miller, a professor of pediatric endocrinology at the University of Florida who specializes in treating children and adults with the syndrome and who is a principal investigator in the VYKAT XR development program. “I am excited to have VYKAT XR available to help treat hyperphagia, which is the most life-limiting aspect of PWS. Families of people with PWS have been prisoners in their own homes because of the need to provide constant, eyes-on supervision 24/7 with access to food being completely restricted.”

The new medication, developed by Soleno Therapeutics, was approved based on four years of data from both double-blind and open label studies, the company said.

VYKAT XR is expected to be available for individuals with Prader-Willi as young as age 4 starting in April.