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PEACE (Pitolisant Expanded Access Clinical Evaluation) Program, an Expanded Access Program, is Now Open

An Expanded Access Program is now open to provide pitolisant* to adult patients with narcolepsy type 1 (with cataplexy) or type 2 (without cataplexy).

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 FDA 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, the patient 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).

As a participant in the PEACE program, the patient will receive pitolisant* at no cost.

To learn more or to find a participating doctor, use this link.

*Pitolisant is an investigational medication in the US that is not currently approved by the FDA. Pitolisant was approved in Europe in March 2016 for the treatment of adult patients with narcolepsy with or without cataplexy. 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.

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Date Created: May 21st, 2019
Last Updated: May 21st, 2019

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