Wakix is the first Health Canada-approved treatment for children 6 years of age and older experiencing excessive daytime sleepiness or cataplexy symptoms associated with narcolepsy.

Paladin Labs Inc, a subsidiary of Endo International plc, announced Health Canada’s approval of Wakix (pitolisant hydrochloride tablets) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients aged 6 years and older and weighing at least 30 kg with narcolepsy.

“Health Canada’s approval of Wakix for appropriate pediatric patients with narcolepsy marks a significant milestone. We are proud to offer an option for Canadians struggling with narcolepsy’s debilitating symptoms, EDS and cataplexy, and potentially empowering caregivers to help manage their condition,” says Livio Di Francesco, vice president and general manager of Paladin Labs Inc. “Paladin Labs is committed to offering innovative treatment options to help support the unmet medical needs of Canadian patients.”

In 2018, Endo Ventures Ltd, a subsidiary of Endo International plc, entered into an agreement with Bioprojet SCR to register, commercialize, and distribute pitolisant hydrochloride on an exclusive basis in Canada. Paladin Labs Inc, an operating company of Endo, is commercializing pitolisant hydrochloride in Canada.

Presently, pediatric patients face a void in Health Canada-approved treatment options. Compounding this challenge is the fact that other approved treatments singularly address either EDS or cataplexy, leaving a critical need for comprehensive treatment, according to a release from Paladin Labs. 

Filling a Gap in Pediatric Narcolepsy Treatment

Wakix is the first and only Health Canada-approved treatment for children 6 years of age and older and weighing at least 30 kg experiencing EDS or cataplexy symptoms associated with narcolepsy. 

Wakix was approved in 2021 in Canada for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. Wakix is a first-in-class highly selective histamine 3 receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the levels of histamine and other wakefulness-promoting neurotransmitters in the brain. It is a once-daily tablet taken in the morning upon waking. 

Wakix is the only treatment approved by Health Canada for cataplexy which is not a controlled drug. Wakix is also marketed in Europe and the United States and is a registered trademark of Bioprojet Europe Ltd.