Bishii Maarso 2, US FDA ayaa oggolaatay codsi cusub oo dawooyin ah (NDA) oo loogu talagalay AZSTARYS (magaca nambarka: KP415), hal mar maalintii, daaweynta daaweynta feejignaan la'aanta feejignaanta (ADHD) ee bukaannada 6 sano iyo ka weyn. Waxaa lagu ganacsan doonaa Mareykanka. Ku
AZSTARYS waa qaab qiyaaseed kaabsal ka kooban oo ka kooban dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) isla markaana si dhakhso leh loo sii daayo d-MPH. AZSTARYS waxay kakooban tahay 30% sii deyn deg deg ah d-MPH iyo 70% sii deynta sii deynta ah ee SDX cusub. Ka dib markii la nuugo marinka mareenka caloosha, SDX waxaa loo beddelaa d-MPH, d-MPH si tartiib tartiib ah ayaa loo sii daayaa maalin gudaheed.
Marka la barbardhigo daawooyinka hadda suuq-geynta ah ee Vyvanse (Ridexamphetamine Dimesylate Capsules) iyo Osmotic (Kiniiniyada Daahfurka Sii-deynta ee Methylphenidate Hydrochloride), AZSTARYS waxay leedahay faa iidada ugu dhaqsaha badan ee bilawga sababo la xiriira sii deynta d-MPH Marka la barbardhigo Adderall XR (kaabsulka amfetamiinka adag ee sii-deynta kaabsoolka ah) iyo Focalin XR (dexmethylphenidate hydrochloride-kaabsol joogto ah), maxaa yeelay SDX waa soo-saar, waxay yareyn kartaa ku-tiirsanaanta daroogada.
Daraasad badan, laba-indhoole, kala-sooc, xakamaynta placebo, wejiga III (NCT03292952) ayaa qiimeeyay waxtarka AZSTARYS. Daraasadu waxay qortay 150 caruur ah oo da doodu udhaxeyso 6-12 sano iyadoo laga helay cudurka ADHD. Natiijooyinka daraasadda ayaa muujisay in marka la barbardhigo kooxda placebo, astaamaha carruurta ee kooxda AZSTARYS si aad ah loo hagaajiyay, dhibcaha SKAMP-C ayaa la dhimay celcelis ahaan 5.4 dhibcood marka la barbar dhigo kooxda placebo.
Maaddaama AZSTARYS ay ku jirto d-MPH, oo ah walax la xakameeyo heerka II, FDA waxay ku talineysaa in AZSTARYS sidoo kale lagu kala saaro iyadoo la raacayo walxaha la xakameeyo ee Heerka II. AZSTARYS ayaa la iibin doonaa xagaaga 2021.
Waqtiga boostada: Meey-17-2021