page_banner

nūhou

Ma Malaki 2, ua ʻae ka US FDA i kahi noi lāʻau hou (NDA) no AZSTARYS (inoa inoa: KP415), hoʻokahi manawa i ka lā, no ka mālama ʻana i ka maʻi hyperactivity deficit attention (ADHD) i nā mea maʻi 6 makahiki a ʻoi paha. E kālepa ʻia ma United States. Iā
ʻO AZSTARYS kahi puʻukū capsule i hana ʻia i haku ʻia o dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) a hoʻokuʻu koke d-MPH. Loaʻa iā AZSTARYS 30% hoʻokuʻu koke d-MPH a 70% hoʻolōʻihi hoʻokuʻu SDX hou. Ma hope o ke komo ʻana i loko o ka gastrointestinal tract, hoʻololi ʻia ʻo SDX i d-MPH, a hoʻokuʻu iki ʻia ʻo d-MPH i loko o hoʻokahi lā.图片2
Ke hoʻohālikelike ʻia me nā lāʻau i kūʻai ʻia i kēia manawa ʻo Vyvanse (Ridexamphetamine Dimesylate Capsules) a me Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), loaʻa i ka AZSTARYS ka pōmaikaʻi o ka hoʻomaka koke ma muli o ka hoʻokuʻu koke ʻia o d-MPH. Hoʻohālikelike ʻia me Adderall XR (amphetamine complex paʻakai paʻa-hoʻokuʻu capsules) a me Focalin XR (dexmethylphenidate hydrochloride mau-hoʻokuʻu capsules), no ka mea he SDr kahi prodrug, hiki iā ia ke hōʻemi i ka hilinaʻi lāʻau.
图片3
ʻO kahi multicenter, blind-blind, randomized, placebo-control, phase III study (NCT03292952) i loiloi i ka pono o AZSTARYS. Ua kiʻi ʻia ka noiʻi 150 mau keiki ma kahi o 6-12 mau makahiki me ka hōʻailona o ADHD. Ua hōʻike ʻia nā hopena o ke aʻo ʻana i ka hoʻohālikelike ʻia me ka hui placebo, ua hoʻomaikaʻi nui ʻia nā ʻōuli o nā keiki ma ka hui AZSTARYS, a ua hoʻemi ʻia ka helu SKAMP-C e ka awelika o nā helu 5.4 i hoʻohālikelike ʻia me ka hui placebo.
图片4
Ma muli o ka AZSTARYS he d-MPH, kahi lāʻau hoʻomalu papa II, ua paipai ka FDA e hoʻokaʻawale ʻia hoʻi ʻo AZSTARYS e like me nā mea i kāohi ʻia i ka papa II. E kūʻai aku ʻo AZSTARYS i ke kauwela o 2021.


Ka manawa o ka manawa: Mei-17-2021