What is an Expanded Access Program?
Expanded access programs provide 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.
The PEACE (Pitolisant Expanded Access Clinical Evaluation) Expanded Access Program (EAP) will allow participating physicians to enroll their adult patients with narcolepsy into the program. Eligible patients will be provided with pitolisant*, which is for the treatment of:
- Excessive daytime sleepiness associated with narcolepsy
- Cataplexy associated with narcolepsy.
Participating physicians enrolled in the PEACE program will be able to provide pitolisant*, an investigational medication in the U.S, to eligible adult patients diagnosed with narcolepsy (type 1 or type 2).
As a treating physician you are invited to participate in this program and enroll your eligible patients. Physicians will be able to arrange (via a specialty pharmacy) for pitolisant* to be delivered directly to their patients, their caregivers, or to themselves (the treating physician), in accordance with the EAP protocol and regulatory requirements applicable to the program. PEACE participants will receive pitolisant* at no cost while participating in the program.
*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).