PARIS, Oct. 9, 2013 /CNW/ - Lancet Neurology, a prestigious journal in
its domain, publishes in its last issue, an article entitled
"Pitolisant versus placebo and modafinil in patients with narcolepsy: a
double-blind randomised trial" authored by Y. Dauvilliers and others
from the HARMONY I study group which proposes a novel treatment for
this orphan disease. It is accompanied by a Commentary entitled "A need
for new treatments in narcolepsy".
Narcolepsy is a rare disabling disorder mainly characterised by
Excessive Daytime Sleepiness (EDS) and cataplexy, a sudden loss of
muscular tone following various emotions. Present treatments comprise
psychostimulants, like modafinil or amphetamine-like compounds, to
fight EDS and sodium oxybate or antidepressants against cataplexy
attacks. However these treatments are not fully satisfactory in terms
of efficacy, tolerance or administration.
Pitolisant is the first representant of a new class of drugs to be
introduced in the clinics, the histamine H3-receptor antagonists; it
was designed in 3 European academic laboratories and developed by
Bioprojet, a small independent French pharmaceutical company.
The HARMONY I trial comprised 95 narcoleptic patients suffering from
severe EDS, among which those treated during 2 months with pitolisant,
once a day orally, showed significant improvement over placebo on
self-reported and laboratory-assessed EDS as well as on frequency
of cataplexy attacks, i.e. the two major symptoms of narcolepsy.
Whereas the pitolisant results on EDS did not differ significantly from
those of twice-a-day modafinil, a currently used comparator, it was
well tolerated compared with modafinil and did not show any
manifestation of addiction potential associated with the use of typical
psychostimulants of the amphetamine type.
If these findings are substantiated in further, currently ongoing,
studies, pitolisant could offer a new treatment option for patients
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