Sleeping during the day! Jazz innovative sunosi is approved by the European Union to treat narcolepsy / obstructive sleep apnea related daytime sleepiness!

January 22, 2020 / BIOON/ --Jazz pharmaceutical company recently announced that the European Commission (EC) has approved sunosi (solriamfetol) for the treatment of adult patients with daytime excessive sleepiness (EDS) related to narcolepsy (with or without fainting) or obstructive sleep apnea (OSA) The drug is specifically applicable to: EDs with major OSA treatment (such as continuous positive airway pressure [CPAP]) not taken For the adult patients with satisfactory results, the consciousness and EDS were improved Sunosi is the first dual acting dopamine and noradrenaline reuptake inhibitor (dnri) approved for the treatment of EDs in adult patients with narcolepsy or OSA The drug is also the only EU approved treatment for EDs in adult OSA patients In the United States, sunosi was approved by the FDA in March 2019 to treat adult patients with daytime excessive sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea Sunosi takes the medicine once a day The approved dosage for narcolepsy patients is 75mg and 150mg, and the approved dosage for OSA patients is 37.5mg, 75mg and 150mg In the European Union, about 16 million people may be affected by some degree of OSA, and some patients continue to experience EDS despite adequate CPAP treatment for upper airway obstruction Sunosi will provide an important treatment option for EDs patients with OSA or narcolepsy "EDS can have a negative impact on the daily lives of people with narcolepsy or OSA, whether at work, at home or in daily activities," said Bruce cozadd, chairman and CEO of jazz In Europe, treatment options are very limited We are very pleased that with this approval, we can provide sunosi, a daytime drug, for European patients with excessive daytime sleepiness due to OSA or narcolepsy, which can provide continuous awake throughout the day " This EU approval of sunosi is based on the data of phase III clinical project tones This project includes four randomized and placebo-controlled studies, namely: the treatment of EDs in adult patients with narcolepsy (the tones-2 study), the treatment of EDs in adult patients with OSA (the tone-3 study, the tone-4 study), and the long-term safety and maintenance effect study (the tones-5 study) for adult patients with narcolepsy or OSA in the treatment of EDs Data from these studies confirm sunosi's superiority over placebo in the treatment of EDS related to narcolepsy and OSA In terms of safety, the most common adverse reactions (incidence ≥ 5% and higher than placebo) in the narcolepsy and OSA study groups were headache, nausea, loss of appetite and anxiety Sunosi was evaluated in more than 900 adult patients with EDS associated with narcolepsy or OSA, and its efficacy remained unchanged after 6 months of use compared with placebo In a 12 week clinical study, using the patient's global impression change scale (PGIC) score, about 68% - 74% of patients taking 75 mg of sunosi and about 78% - 90% of patients taking 150 mg of sunosi reported an improvement in their overall clinical status At week 12, compared with the placebo group, patients with narcolepsy treated with a dose of 150 mg of sunosi and patients with OSA treated with all doses showed improvement in the level of wakefulness assessed during test 1 (approximately 1 hour after administration) to test 5 (approximately 9 hours after administration) of the maintenance of wakefulness test (MWT) It should be pointed out that sunosi is not suitable for the treatment of OSA potential airway obstruction In OSA patients, ensure that potential airway obstruction (e.g., continuous positive airway pressure ventilation [CPAP]) is treated at least one month prior to the initiation of sunosi for EDs During the treatment with sunosi, the treatment of potential airway obstruction should be continued, and sunosi is not a substitute for these methods Sonosi is a selective dopamine and norepinephrine reuptake inhibitor (dnri), which is currently being developed for the treatment of EDs in adult patients with narcolepsy, OSA and Parkinson's disease In 2014, jazz acquired the global development and commercialization rights of solrimmetol from aerial biopharma, except for parts of Asia Sk biopharmaceutical company is the discoverer of the compound, which has the rights of solrimmetol in 12 Asian markets including South Korea, China and Japan In the United States, solriamfetol has been approved by the FDA as an orphan drug for the treatment of narcolepsy At present, the listed drugs for the treatment of EDs in adult patients with narcolepsy or OSA include modafinil and amoafinil Jazz has also been selling a sleep drug, xyrem, for children and adults aged 7 and over to treat sudden onset and excessive daytime sleepiness, with sales of $1.18 billion in 2017 Original source: Jazz pharmaceuticals receives EU marketing authorization for sunosi ® (solriamfetol) for exceptional daytime sleepiness in results with narcolepsy or objective sleep apnea