ALKS3831 (olanzapine / samidorphan) Rov Txais los ntawm Asmeskas FDA rau Kev Kho Mob ntawm Schizophrenia / bipolar I Disorder

Alkermes yog lub tuam txhab ua lag luam ua ke ua lag luam ua ke nrog Irish tsim kho cov tshuaj tshiab rau kev kho mob hauv nruab nrab cov hlab hlwb (CNS) kab mob thiab cov qog. Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau lees paub tias tau txais lub tuam txhab rov qab xa npe ALKS3831 (olanzapine / samidorphan) Daim Ntawv Thov Tshuaj Tshiab Tshiab (NDA), uas yog ib qho tshiab, ib zaug-txhua hnub atypical tshuaj tiv thaiv kev siv tshuaj tiv thaiv kev siv. kho tus mob schizophrenia thiab cov laus bipolar hom 1 tsis meej. FDA tau xaiv qhov tshiab" Tus Neeg Them Tshuaj Txhaum Cai Siv Tshuaj" (PDUFA) lub hom phiaj hnub tim Lub Rau Hli 1, 2021.

Lub FDA tau faib cov ntawv tshaj tawm uas yog daim ntawv ceeb toom ua tiav theem ob rau tsab ntawv teb tiav (CRL) tawm thaum Lub Kaum Ib Hlis 2020. Lub sijhawm ntawd, raws li Seem 704 (a) (4) ntawm Tsoomfwv Txoj Cai Tswjfwm Khoom Noj, Yeeb Tshuaj, thiab Tshuaj Zoo ( tom qab no xa mus rau" FDCA"), FDA soj ntsuam kev tshuaj xyuas chaw deb ntawm lub tuam txhab ALKS3831 cov ntaub ntawv ntau lawm hauv Wilmington, Ohio cog. Daim CRL tau tshaj tawm, taw qhia qee yam teeb meem ntsig txog txheej txheem txheej ntsiav tshuaj ntawm lub hoobkas, uas yog tshwj xeeb rau qee hom kev loj hlob ntawm ALKS3831. Tom qab Alkermes rov pom zoo NDA, FDA tau tawm daim ntawv thov cov ntaub ntawv tshiab nyob rau hauv Tshooj 704 (a) (4) ntawm FDCA los ntxiv cov ntaub ntawv uas tau muab los ntawm lub tuam txhab. Tsis yog CRL los yog cov ntawv thov tom qab ntawv pom lossis tsa lus nug txog cov chaw kuaj mob lossis cov ntaub ntawv tsis nyob hauv NDA, thiab FDA tsis tas yuav Alkermes ua tiav txhua qhov kev sim tshuaj tshiab los txhawb NDA pom zoo.

Alkermes yuav txuas ntxiv ua haujlwm nrog FDA kom ua tiav kev tshuaj xyuas ALKS3831 NDA thiab tau cog lus tias yuav muab ALKS3831 rau cov neeg mob kom sai li sai tau.

ALKD3831 yog lub tshuaj txheej ob txheej ua los ntawm cov tshiab tshiab cov tshuaj molecular samidorphan (tshiab tshiab xaiv μ-opioid receptor antagonist) thiab kev lag luam tshuaj tiv thaiv kev lag luam olanzapine. Qhov hnyav nce thiab cov teeb meem hauv lub tsev kho mob ntsig txog lub cev yog cov kev mob tshwm sim ntawm atypical anti-schizophrenics. Olanzapine yog ib qho tshuaj tiv thaiv kev tiv thaiv zoo, tab sis nws txoj kev siv tshuaj kho mob tau txwv los ntawm nws qhov hnyav ntawm qhov hnyav nce. ALKD3831 yog tsim los muab olanzapine' s muaj zog tiv thaiv kev tiv thaiv thaum txo cov kev mob tshwm sim ntawm lub cev qhov hnyav thiab cov metabolism, thiaj li txhim kho kev nyab xeeb ntawm kev kho.

ALKS3831 yog qhov tshiab ntawm qhov ncauj tiv thaiv atypical antipsychotic, ib hnub ib zaug, tsim kho kev mob schizophrenia thiab kev puas siab puas ntsws bipolar I. Cov tshuaj yog tsim los muab cov teebmeem ntawm olanzapine thaum txo qhov hnyav nce los ntawm olanzapine. ALKS3831 muaj 4 qhov sib txuam-koob tshuaj sib xyaw, uas yog tsim nrog koob tshuaj 10mg ntawm samidorphan thiab txawv ntawm olanzapine (5mg, 10mg, 15mg, 20mg).

Thaum Lub Kaum Hlis xyoo no, FDA Pab Pawg Sab Laj txog Tshuaj Yeeb Tshuaj thiab Kev Nyab Xeeb thiab Kev Nyab Xeeb thiab Tswv Yim Tswj Xyuas Kev Nyab Xeeb tau tuav lub rooj sib tham los tham txog ALKS3831 Pawg neeg koom ua ke pov ntawv tawm suab tias samidorphan muaj txiaj ntsig txo qhov hnyav los ntawm olanzapine (16 suab pom zoo, 1 pov npav tawm tsam), thiab cov kev nyab xeeb ntawm ALKS3831 tau piav qhia tag nrho (13 cov neeg pom zoo, 3 pov npav tsis zoo, thiab 1 tsis suav nrog) Cov. Ntxiv rau, pawg neeg koom ua ke pov ntawv tawm suab tias daim ntawv qhia tshuaj yog txaus los txo cov kev pheej hmoo cuam tshuam nrog kev cuam tshuam ntawm samidorphan opioid antagonists (11 suab pom zoo, 6 pov npav tawm tsam). Alkermes 'kev thov cov tshuaj cim txwv tsis pub siv tshuaj ALKS3831 hauv cov neeg mob uas opioid siv lossis siv opioid ntev. Lub tuam txhab kuj tau hais kom muaj kev qhia ntawv dav dav uas suav nrog kev tshaj tawm cov ntaub ntawv rau cov kws kho mob thiab cov kws muag tshuaj.

Tus qauv molecular ntawm samidorphan (daim duab duab: ebiochemicals.com)

Lub ALKD3831 NDA suav nrog cov ntaub ntawv los ntawm ENLIGHTEN qhov kev txhim kho kev kho mob (suav nrog 2 ntu tseem ceeb ntawm III kev tshawb fawb ENLIGHTEN-1 thiab ENLIGHTEN-2) nqa tawm hauv cov neeg mob schizophrenia, thiab piv cov pharmacokinetics ntawm ALKS3831 thiab cov tshuaj lag luam Zyprexa (olanzapine) Kinetics (PK) ) bridging cov ntaub ntawv tshawb fawb los txhawb kev kho mob schizophrenia kev qhia, thiab kev kho mob ntawm kev puas siab puas ntsws bipolar I kev cuam tshuam txog kev puas siab puas ntsws lossis kev sib xyaw ua ke thiab kev saib xyuas raws li ib tus neeg sawv cev lossis kev kho mob uas muaj kev kho nrog lithium lossis sodium valproate Kev kho mob bipolar hom I kev cuam tshuam.

ENLIGHTEN-1 yog 4-lub lim tiam randomized, ob chav dig muag theem III kawm nyob rau hauv cov neeg mob schizophrenia uas tau muaj kev mob exacerbations. Nws muab piv rau qhov tshuaj tiv thaiv kev tiv thaiv kev tiv thaiv, kev nyab xeeb thiab kev tiv taus ntawm ALKS3831 txheeb ze rau cov tso tso. Cov txiaj ntsig tau qhia tias qhov kev tshawb fawb tau mus txog qhov kawg: ua piv nrog cov placebo pab pawg, qhov zoo thiab tsis pom cov tsos mob (PANSS) cov qhab nia ntawm pawg ALKS3831 kho tau pom tias muaj tsawg zuj zus ntawm qhov pib. Txoj kev tshawb no tseem suav nrog pawg kho mob olanzapine, tab sis kom tsis txhob sib piv cov kev ua tau zoo lossis kev nyab xeeb ntawm ALKS3831 thiab olanzapine. Cov ntaub ntawv tshawb fawb qhia tau hais tias piv nrog cov placebo pab pawg, olanzapine kho mob pab pawg muaj qhov kev txhim kho zoo sib xws hauv PANSS cov qhab nia los ntawm qhov pib.

ENLIGHTEN-2 yog phau ntawv 6 lub hlis, ob chav dig muag theem III kawm ua nyob rau hauv cov neeg mob uas muaj tus mob schizophrenia ruaj khov los soj ntsuam cov teebmeem ntawm ALKS3831 thiab cov placebo ntawm lub cev qhov hnyav. Cov txiaj ntsig pom tau hais tias txoj kev tshawb no tau mus txog qhov pom qhov tseem ceeb tshaj plaws, qhia tias piv nrog olanzapine pawg kho mob, pawg kho mob ALKS3831 muaj qhov hnyav nruab nrab qis dua los ntawm lub hauv paus thaum 6 lub hlis ntawm kev kho mob, thiab thaum lub hli 6 ntawm kev kho mob. cov neeg mob nrog qhov hnyav nce ntawm ≥10% qis dua.