Paladin Labs Says Wakix Approved In Canada For Cataplexy In Adult Patients With Narcolepsy

Canadian specialty pharmaceutical company Paladin Labs Inc., a unit of Endo International plc (ENDP), announced Wednesday Health Canada's approval of Wakix (pitolisant).

The drug is approved for the treatment of excessive daytime sleepiness or EDS or cataplexy in adult patients with narcolepsy.

Narcolepsy is a rare but serious sleep disorder, which is estimated to affect up to 25,000 people in Canada.

Wakix (pitolisant 4.5mg and 18mg tablets) is the first and only Health Canada approved treatment for adult patients experiencing both excessive daytime sleepiness and cataplexy symptoms associated with narcolepsy. It is a once-daily tablet taken in the morning upon waking.

Paladin said it plans to work collaboratively with the Canadian Agency for Drugs and Technologies in Health or CADTH and the Institut national d'excellence en santé et en services sociaux (INESSS) to ensure patients have access to Wakix as soon as possible.

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

Wakix is currently marketed in Europe and the United States and is a registered trademark of Bioprojet Europe Ltd.

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