European Union approval of a new drug for somnolence: treatment of narcolepsy / obstructive sleep apnea related daytime excessive somnolence

November 19, 2019 / Biovalley BIOON / - Jazz pharmaceutical company recently announced that the European Drug Administration (EMA) human pharmaceutical products Committee (CHMP) has issued a positive review opinion, recommending the approval of solriamfetol for adult patients with narcolepsy (with or without syncope) or obstructive sleep apnea (OSA), improving wakefulness and reducing excessive daytime sleepiness (EDS), specifically: The main OSA therapy (such as continuous positive airway pressure ventilation [CPAP]) for EDs was not satisfactory CHMP suggests that for patients with narcolepsy, it is recommended to take the medicine once a day, with the dosage of 75mg and 150mg; for patients with OSA, it is recommended to take the medicine once a day, with the dosage of 37.5mg, 75mg and 150mg Solriamfetol is a dual acting dopamine and norepinephrine reuptake inhibitor (dnri), which has been shown to improve arousal in adults in the treatment of EDS associated with narcolepsy or OSA The CHMP's comments will now be reviewed by the European Commission (EC), which is expected to make a final decision within the next two months If approved, solriamfetol will be the only drug approved in Europe for the treatment of EDs in adult OSA patients In the United States, solriamfetol was approved by FDA in March 2019 Its brand name is sunosi, which is suitable for the treatment of EDS related to narcolepsy or OSA in adult patients It is worth mentioning that sunosi is the first dual acting dopamine and noradrenaline reuptake inhibitor (dnri) approved by FDA for the treatment of EDs in adult patients with narcolepsy or OSA In terms of medication, 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 Robert Iannone, MD, executive vice president of pharmaceutical research and development, jazz, said: "the positive views of CHMP are an important milestone for patients with narcolepsy or OSA related EDs EDS can have a negative impact on patients' daily life, whether in work, family or daily activities This milestone brings us a step closer to providing new treatments for people with sleep disorders in Europe " Positive comments on CHMP's recommendation for approval are based on data from tones, a phase III clinical project 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 noted 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 Currently, modafinil and amoafinil are also on the market to treat EDs in adult patients with narcolepsy or OSA In addition to sunosi, jazz has also been selling a sleep drug, xyrem, for children and adults aged 7 and over to treat the sudden onset of narcolepsy and excessive daytime sleepiness In 2018, sales of the drug reached US $1.405 billion, an increase of 18% over 2017 Original source: Jazz pharmaceuticals receives positive CHMP operation for solriamfetol to improve wakefulness and reduce excessive daytime sleepiness in results with narcolepsy or obstructive sleep apnea