purongo

I te Poutu-te-rangi 2, kua whakaaetia e te US FDA tetahi tono tarukino hou (NDA) mo AZSTARYS (ingoa waehere: KP415), kotahi i te ra, mo te rongoa i te mate hyperactivity deficit attention (ADHD) ki nga tuuroro 6 tau neke atu ranei. Ka tauhokohoko ki te United States. Ki
Ko te AZSTARYS he momo inenga putuputu mai i te dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) me te tuku tonu d-MPH. Ko te AZSTARYS e 30% te tuku wawe-i te MPH me te 70% whakawhanui tuku i te SDX hou. Whai muri i te ngongo o te ara gastrointestinal, ka hurihia te SDX ki te d-MPH, ana ka tukuna te d-MPH i roto i te ra kotahi.
Ki te whakatauritea ki nga raau rongoa e hokona ana i tenei wa ko Vyvanse (Ridexamphetamine Dimesylate Capsules) me Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), AZSTARYS te painga o te tiimatanga tonu na te tuku wawe o te d-MPH. Ki te whakataurite ki te Adderall XR (te amphetamine matatini tote pupuri-tuku potae) me te Focalin XR (dexmethylphenidate hydrochloride paturu-tuku penehana), na te mea ko te SDX he kaiwhakanao, ka taea te whakaiti i te whakawhirinaki raau.

He maha, maha-matapo, tupurangi, whakahaere-waahi, rangahau waahanga III (NCT03292952) i arotake i te kaha o nga AZSTARYS. I whakatauhia e te rangahau nga tamariki 150 mai i nga tau 6-12 tau me te tohu ADHD. I whakaatuhia nga hua o te rangahau i whakaritea ki te roopu placebo, he pai ake te whakapai ake i nga tohu o nga tamariki i te roopu AZSTARYS, a ko te kaute SKAMP-C i whakaitihia ma te toharite o nga tohu 5.4 kua whakaritea ki te roopu placebo.

I te mea ko te AZSTARYS he d-MPH, he taonga e whakahaerehia ana e te Akomanga II, e taunaki ana te FDA kia whakarōpūhia hoki a AZSTARYS e ai ki nga matū a te Akomanga II. Ka hokona a AZSTARYS i te raumati o te 2021.