A new drug is close to changing the way narcolepsy is treated, after clinical trials showed promising results for the drug "ofporexone," which targets a deficiency of a key substance in the brain that helps regulate sleep and wakefulness.
Those with narcolepsy suffer from sudden episodes of drowsiness that can turn into deep sleep during the day, even while talking or engaging in daily activities.
These episodes may be accompanied by cataplexy, a sudden and temporary loss of muscle control that can cause the person to fall. Cataplexy often occurs in response to strong emotions such as laughter, surprise, excitement, or anger. Those affected may also experience sleep paralysis, during which they lose the ability to move or speak for a short period while transitioning between sleep and wakefulness.
Ovpurexton works by activating orexin-2 receptors in the brain, stimulating the production of this neurotransmitter by cells in the hypothalamus. Orexin plays a role not only in regulating sleep and wakefulness but is also involved in attention, motivation, and the brain's reward system.
The first type of narcolepsy, the most common and accounting for about 75% of cases, is linked to the loss of cells responsible for producing orexin. This is believed to occur as a result of a malfunction in the immune system, which mistakenly attacks these cells, leading to decreased orexin levels and disrupting the brain's ability to regulate sleep and wakefulness.
In clinical trials involving more than 270 patients with narcolepsy, participants took ofproxen twice daily for three months. Results published by Takeda, the drug's manufacturer, showed a significant improvement in daytime alertness, along with an average reduction of approximately 80% in cataplexy episodes.
Most of the side effects recorded during the trials were mild, including nighttime insomnia and increased urination.
Guy Lechzner, professor of neurology and sleep medicine and consultant neurologist at Guy's and St Thomas' Hospital in London, said that developing a drug that targets the orexin pathway has been a key goal in the treatment of narcolepsy for years.
He added in statements to "Good Health" magazine that the drug is the first of its kind to reach the market, and that the results of clinical trials are "very encouraging," considering it a promising option for those suffering from this debilitating neurological disorder.
The US Food and Drug Administration approved the use of ufporexone for the treatment of narcolepsy last month. In the UK, the National Institute for Health and Care Excellence (NICE) is currently assessing the feasibility of providing the drug within the National Health Service (NHS), with estimates suggesting a cost of around £120,000 per patient per year. A final decision is expected by April 2027.
Current treatments focus on managing the symptoms of the disease, including modafinil, which helps promote daytime alertness, and sodium oxybate, which promotes deep sleep at night to reduce daytime sleepiness. These medications can be associated with various side effects, highlighting the need for new treatment options.
The importance of developing more effective treatments is further underscored by studies suggesting that narcolepsy may be linked to an increased risk of premature death. International researchers followed thousands of people with the disorder for 25 years and found they were up to 30% more likely to die at a younger age than those without the condition. The findings, published in the Journal of Clinical Sleep Medicine in May, indicated that the increased risk is associated with other conditions that may accompany chronic sleep disorders, including heart disease, type 2 diabetes, and certain mental health conditions.
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