People with this condition have extreme sleepiness during the day and a hard time focusing or staying awake.
They may also experience something called a cataplexy attack. These attacks are usually caused by strong emotions, like laughter or surprise, and cause you to lose muscle control.Narcolepsy type 1 happens when the brain loses certain cells that make a chemical called orexin. Orexin helps control sleep and wake cycles. Without enough orexin, the brain struggles to stay awake and to separate sleeping and waking periods. Orzeyful works by attaching to orexin receptors in the brain. This replaces the missing orexin signal and helps the brain to control its sleep and wake cycles. Although other medicines are approved to treat this condition, Orzeyful is the first medicine designed to target the biological cause of narcolepsy type 1.
Why Was It Approved?
The FDA approved Orzeyful based on two 12-week clinical trials involving 273 adults with narcolepsy type 1. Some people in the study took Orzeyful while some took a placebo (a pill with no active medicine). To measure the effects of the medicine, each person in these studies was asked to sit on a bed in a dark, quiet room for 40 minutes at a time. They were told to stay awake as long as possible during each session. Patients taking Orzeyful stayed awake for 12-19 minutes longer than they did before they started the medicine. This was much longer than patients taking placebo, who stayed awake about 1 minute less than they did before starting the placebo. Patients on Orzeyful also felt less sleepy during the day and had fewer cataplexy attacks each week compared to those taking the placebo.
What Do I Need to Know About Orzeyful?
Orzeyful is a tablet that you swallow whole with water. You will take it by mouth two separate times every morning. The first dose is taken right after you wake up. The next dose is taken about three to five hours later. Each of these doses should be taken around the same time each day. You can take the medicine with or without food.
