What is an Expanded Access Program?
Expanded access provides a way for patients to gain access to investigational treatments for serious diseases or conditions, prior to them being approved by the Food and Drug Administration as being safe and effective. Therefore, they may or may not be an effective treatment, and the treatment may have unexpected serious side effects. Patients should consider all possible risks when seeking access to an investigational medical product.
In the PEACE program, which stands for Pitolisant Expanded Access Clinical Evaluation, you will receive pitolisant*, an investigational medication used to treat the symptoms of excessive daytime sleepiness and cataplexy in adult patients with narcolepsy (type 1 or type 2). Pitolisant was approved in Europe in March 2016 for the treatment of adult patients with narcolepsy with or without cataplexy (type 1 and type 2).
As a participant in the PEACE program you will receive pitolisant* at no cost to you.
*Pitolisant is an investigational medication in the U.S that is not currently approved by the Food and Drug Administration (FDA). Harmony Biosciences, LLC, in partnership with Bioprojet, will be submitting a New Drug Application to the FDA for the evaluation of the safety and effectiveness of pitolisant. Pitolisant was approved in Europe in March 2016 for the treatment of adult patients with narcolepsy with or without cataplexy (type 1 and type 2).