Is Pitolisant-wakix on the market?

Oral Pitolisant tablets (Pitolisant)-wakix, usually marketed under the trade name Wakix, was approved by the European Medicines Agency (EMA) in July 2016 for the treatment of narcolepsy with or without cataplexy. Studies have shown that tilolixen tablets can effectively reduce the two main symptoms of narcolepsy in adults, adolescents and children over 6 years of age, namely excessive daytime sleepiness and cataplexy. In addition, Tilolixen tablets differ from currently available treatments and thus provide an alternative treatment option for patients with narcolepsy. The safety profile of tilolixen tablets was considered acceptable, and no major safety issues were identified.

The U.S. Food and Drug Administration (FDA) approved the use of tilolixen tablets in 2019 to treat excessive daytime sleepiness (EDS) associated with narcolepsy in adults. In a European clinical trial of adults with narcolepsy, treatment with vasopressin reduced Epworth Sleepiness Scale (ESS) scores compared with placebo. Tilolixen tablets are as effective as modafinil. Treatment with tilolixen tablets is also effective for refractory sleepiness in adolescent patients with narcolepsy, reducing ESS scores and increasing mean sleep onset latency. Adolescents with cataplexy also experienced modest improvements in frequency and symptom severity; however, the safety of tilolixen tablets in adolescents or children has not been established.

On June 30, 2023, the National Medical Products Administration approved tilolixen tablets for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. In China, tilorisen tablets are the first innovative drug approved for the treatment of narcolepsy and the only non-scheduled drug with indications for narcolepsy. Its name is Tilolixen Hydrochloride Tablets, and it may be sold under the trade name of Huacos.

The price of each box of the original version of tilorisen tablets marketed overseas may be more than more than 4,000 yuan (the price may fluctuate due to exchange rates). Currently, there are no generic versions of tilorisen tablets produced and marketed overseas.