Clinical trials on WAKIXįDA approval of WAKIX was based on the two multi-centre, randomised, double-blind, placebo-controlled trials, HARMONY CTP and HARMONY 1. WAKIX binds to H 3 receptors selectively and increases synthesis and release of histamine, a neurotransmitter that promotes wakefulness in the brain. The mechanism of action of WAKIX is unclear, however, its efficacy can be established through its activity on H 3 receptors. Pitolisant is a potent and highly selective antagonist or inverse agonist of the histamine-3 (H 3) receptor. All narcolepsy patients show excessive daytime sleepiness, while approximately two-thirds of them experience catalepsy. It ranges from moderate symptoms, such as drooping of eyelids, to severe, such as buckling of the knee or complete collapse of the body.Ĭataplexy may have a profound effect on the ability of a person to perform normal functions.

It is an attribution of REM sleep dysregulation, causing wakefulness. The FDA approved WAKIX (pitolisant) for the treatment of EDS in adult patients with narcolepsy in August 2019 and extended the label for the treatment of cataplexy in adult narcolepsy patients in October 2020.Ĭataplexy is one of the physical manifestations of narcolepsy, the most debilitating chronic, rare neurological condition, characterised by abrupt, transient lack of muscle tone, often induced by strong feelings such as excitement or laughter. Harmony submitted an original new drug application (NDA) for pitolisant to the FDA for the treatment of EDS and cataplexy in adult patients with narcolepsy in December 2018 and the application was accepted for review in February 2019. The US Food and Drug Administration (FDA) provided orphan designation to pitolisant for narcolepsy in 2010, while breakthrough therapy designation to the drug for cataplexy in patients with narcolepsy was granted in April 2018. Harmony holds an exclusive authorisation from Bioprojet for the development, manufacturing and commercialisation of pitolisant in the US. This book reviews the literature on these tonic immobility (TI) phenomena in animals and the comparative psychological research that has investigated how this model can contribute to our understanding of aspects of human behavior.The drug is marketed or distributed under a compassionate use programme in nine countries in the European Union (EU), including Germany, France, Netherlands, Italy, Belgium, Ireland, UK, Switzerland and Spain. For some years now, investigations have been examining analogies between this phenomenon and conditions occurring in humans, such as the immobility that accompanies severe trauma and sexual violence, wartime situations, catalepsy, cataplexy, catatonia and the immobility experienced in panic attacks. Over time, the phenomenon has gone by several names, from the most evocative animal hypnosis to the more scientific tonic immobility. This book reviews the literature on these tonic immobility (TI) phenomena in animals and the comparative psychological research that has investigated how this model can contribute to our understanding of aspects of human behavior.ĪB - Since ancient times, a curious phenomenon has been described in many animal species: people have been able to induce state of prolonged immobility in the animal by using various methods. N2 - Since ancient times, a curious phenomenon has been described in many animal species: people have been able to induce state of prolonged immobility in the animal by using various methods. T2 - Studies on the tonic immobility in animals from a comparative psychology perspective

Catalepsy vs cataplexy