About PEACE - Peace Patient PRR

About PEACE

An expanded access program (EAP) that allows for the treatment of adult patients with the symptoms of excessive daytime sleepiness (EDS) and/or cataplexy associated with narcolepsy (type 1 or type 2).

  • Pitolisant* is a novel, selective, orally active histamine H3 receptor antagonist/inverse agonist.
  • Through the enhancement of histaminergic transmission in the brain, pitolisant* has been shown to exhibit strong waking effects and improved attention levels in animal studies.
  • 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); however, it is not currently approved for use in the U.S.
  • More information about pitolisant* will be made available after you register as a participating physician in the PEACE Program.
  • As with any investigational medication that has not been approved by the FDA, pitolisant* may or may not be effective in treating your patients’ condition and there may be risks [learn more button/link] associated with its use.
  • If you would like more information on EAPs, please visit the Expanded Access Program Information for Physicians.
  • Patients who participate in the PEACE program will receive pitolisant* at no cost.
  • Once an order is placed, pitolisant* will be sent directly to the patient, his/her caregiver or to his/her treating physician.
  • Costs for routine medical care while participating in the program are not reimbursed by Harmony Biosciences, LLC and will need to be covered by the patient’s insurance or at his/her own expense.
  • If you are interested in participating in the PEACE program, please follow these steps:
    • Check the key patient eligibility criteria below to see if you have any patients that would qualify to participate in the program.
    • Click here to connect to the registration website, which will allow you to register yourself and any eligible patients who agree to enroll in the program.

Key patient eligibility criteria

Men or women, 18 years of age and over.

Diagnosis of narcolepsy (type 1 or type 2) according to the International Classification of Sleep Disorders Third Edition (ICSD-3) criteria.

*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).

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