Welcome to “A to Z: Drugs in Highlight
This series is designed to delve into the intricate realm of pharmaceutical drugs. As the world of pharmaceuticals continues to evolve with new discoveries and emerging challenges, we aim to shed light on the diverse array of medications available today, ranging from blockbuster medications to those that may not be as familiar. Whether you’re a healthcare professional, a student, or simply someone with a curious mind, “A to Z: Drugs in Highlight” promises to be an enlightening and engaging series.
W is for WAKIX®
WAKIX® (from Bioprojet Pharma) is used to treat narcolepsy in adults, adolescents and children from 6 years of age.
How it works:
Narcolepsy is a rare chronic neurological disorder that affects the brain’s ability to regulate sleep-wake cycles. People with narcolepsy experience excessive daytime sleepiness and may suddenly fall asleep during various activities. Other symptoms include cataplexy (sudden and temporary loss of muscle control resulting in weakness and possible collapse triggered by strong emotions), sleep paralysis (temporary inability to move or speak when waking up or falling asleep) and hallucinations (vivid dreams or hallucinations while falling asleep or waking up). The exact cause of narcolepsy is not fully understood, but it is often associated with low levels of hypocretin (also known as orexin), a chemical in the brain that helps regulate sleep.
WAKIX® is used to treat narcolepsy patients with or without cataplexy. The active substance in WAKIX® is pitolisant. Pitolisant works by blocking histamine from attaching to the histamine H3 receptor on nerve cells. This action leads to an increase histamine production in the brain. The newly produced histamine then attaches to the histamine H1 receptor, which enhances the activity of histaminergic neurons. These neurons play a crucial role in regulating sleep and wakefulness.
Market impact:
WAKIX® is approved for marketing in the United States (approved by the FDA in August 2019) and in Europe (approved by the EMA in March 2016). WAKIX® received orphan drug status (designation given to drugs intended for the treatment of rare diseases) from both the FDA and EMA for the treatment of narcolepsy.
WAKIX® was designed and developed by Bioprojet Pharma. Harmony Biosciences has an exclusive licence from Bioprojet to develop, manufacture and commercialize WAKIX® in the United States.
Patent protection:
One of the first European patents protecting WAKIX® was EP1428830. EP1428830 related to compounds of formula (IIa)
, with pitolisant specifically claimed in claim 12 as granted. EP1428830 expired in 2019, and the Supplementary Protection Certificates (SPCs) based on EP1428830 expired in 2024.
There are still patent rights protecting various aspects of WAKIX® in the United States and Europe. For example, in Europe, EP1846384 relates to crystalline 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride of formula (I)
and its pharmaceutically acceptable solvates, including hydrates. EP1846384 is due to expire in February 2026.
Patent support from Secerna
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