Cov Tshuaj Kho Mob Tshiab Kho Tus Mob Qhwv Yeeb! Axsome Lub Qhov Ncauj Tshiab Lub Qhov Ncauj Ntau Lub Txheej Txheem Yeeb Tshuaj AXS-07 Theem III Soj Ntsuam Qhov Ua Tau Zoo Tseem Ceeb Tshaj Li Rizatriptan!

Axsome Kev Kho Mob yog lub tuam txhab kev siv tshuaj biopharmaceutical kom pab tsim kho tshiab los kho cov hauv nruab nrab cov hlab hlwb (CNS). Tsis ntev los no, lub tuam txhab tshaj tawm tias nyob rau hauv Theem III MOMENTUM kev sim rau kev kho mob taub hau mob hnyav: piv nrog cov tshuaj tswj hwm cov tshuaj rizatriptan, nws qhov ncauj tshiab ntau cov tshuaj AXS-07 sai sai rau mob taub hau thiab txo cov kev mob rov qab heev. Cov kev tshawb pom no tau tshaj tawm txog 2020 American Academy of Neurology (AAN) Science Highlights platform.

AXS-07 yog hom tshiab ntawm cov tshuaj qhov ncauj nrog qhov tshwj xeeb dual kev ua ntawm kev ua. Tam sim no nws tau raug soj ntsuam kev loj hlob rau kev kho mob tob hau ntawm migraine. AXS-07 yog tsim ntawm MoSEIC meloxicam thiab rizatriptan. Meloxicam yog qhov chaw tshiab molecular uas siv Axsome' s MoSEIC (Molecular Solubility Enhancement Inclusion Compound) thev naus laus zis kom ua tiav cov kev kho mob ntawm migraine Cov thev naus laus zis no nqus sai ntawm meloxicam thaum tswj cov ntshav plasma ntev ntev ib nrab. Meloxicam yog COX-2 ib qho tshuaj tsis yog-steroidal anti-inflammatory tshuaj, thiab rizatriptan yog 5-HT1B / 1D agonist. AXS-07 yog tsim los muab kev pabcuam nrawm nrawm, txhim kho thiab pab tau mob tob hau thiab txo qis cov tsos mob tshwm sim.

MOMENTUM yog kev xaiv, ob qhov muag tsis pom kev, tshuaj placebo, thiab tshuaj muaj txiaj ntsig nyob hauv kev sim qib III raws li FDA Kev Ntsuam Xyuas Tshwj Xeeb Txheej Txheem (SPA) txhawm rau soj ntsuam cov txiaj ntsig thiab txiaj ntsig ntawm AXS-07 hauv kev kho mob me ntsis mus rau mob hnyav migraine kev nyab xeeb. Txoj kev tshawb no siv cov lus nug txog Kev Tsuag Tshuaj Kho Mob Migraine [mTOQ-4] los ntsuas thiab tsuas yog suav nrog cov neeg mob muaj keeb kwm tsis muaj lus teb rau kev kho mob tob hau dhau los. Hauv txoj kev tshawb no, tag nrho ntawm 1594 cov neeg mob tau muab faib rau ntawm qhov sib piv ntawm 2: 2: 2: 1 kom tau txais AXS-07 (20mg MoSEIC meloxicam / 10mg rizatriptan), rizatriptan (10mg), MoSEIC Meloxicam (20mg), cov tshuaj placebo Cov. Ob qhov sib koom ua ke kawg ntawm txoj kev tshawb no yog qhov feem ntawm cov neeg mob uas mob taub hau raug tshem tawm 2 teev tom qab kev tswj hwm ntawm AXS-07, thiab qhov sib piv ntawm cov neeg mob uas cuam tshuam nrog ntau yam mob ntsig txog mob taub hau (xeev siab, photophobia, lossis soundphobia) raug tshem tawm. hauv 2 teev tom qab kev coj noj coj ua. Cov. Rizatriptan yog qhov tshuaj tswj tau zoo hauv txoj kev kawm no. Nws tau suav hais tias yog kev nrawm ntawm lub qhov ncauj taug kev thiab ib qho ntawm cov tshuaj zoo tshaj plaws tam sim no muaj rau kev kho mob tob hau ntawm migraine.

Cov kev tshaj tawm yav dhau los pom tau hais tias txoj kev tshawb nrhiav mus txog ob qhov kev cai tseem ceeb: Qhov piv nrog cov placebo, AXS-07 txhim kho kev mob taub hau ntau dua thiab cov tsos mob cuam tshuam ntau tshaj plaws. Txuas ntxiv, AXS-07 kuj tseem mus txog qhov tseem ceeb theem nrab kawg, pom qhov kev sib tw zoo tshaj qhov kev tswj hwm cov tshuaj nquag rizatriptan nyob rau hauv cov nqe lus ntawm kev pab kho mob taub hau mob kom zoo.

Cov ntaub ntawv tso tawm ntawm AAN lub rooj sib tham qhia tau tias AXS-07 pom tias kev nrawm nrawm thiab kav ntev dua piv nrog rizatriptan. Qhov tshwm sim ntawm kev noj tshuaj AXS-07 los daws qhov mob yog ntau dua li rizatriptan tsis pub dhau 30 feeb tom qab kev tswj hwm thiab txhua lub sijhawm taw tes tom qab; cov sijhawm nruab nrab rau kev mob taub hau tau ua tiav, thiab tus nqi ntawm kev nyem ntawm AXS-07 piv rau cov rizatriptan Qhov no yog ze li 3 zaug nrawm dua (1.5 vs 4.0 teev, p< 0.001).="" piv="" nrog="" rizatriptan,="" axs-07="" txo="" qis="" kev="" mob="" taub="" hau="" ntau="" ntxiv:="" hauv="" 48="" teev="" noj="" rizatriptan,="" 45.2%="" ntawm="" cov="" neeg="" mob="" kho="" rizatriptan="" tau="" muaj="" kev="" pheej="" hmoo,="" piv="" nrog="" 21,2%="" ntawm="" cov="" neeg="" mob="" kho="" axs-07="" (p="">

Yuav kom ua tiav lub txiaj ntsig kev mob taub hau thiab rov tshwm sim lub sijhawm, qhov zoo ntawm AXS-07 dhau los rizatriptan zoo ib yam nyob hauv ntau lwm yam kev ntsuas, raws li tau hais los saum no, suav nrog kev siv tshuaj tiv thaiv kev mob taub hau (p< 0.001),="" 24="" teev="" (p="0.006)" thiab="" 48="" teev="" (p="0.003)" kev="" kho="" mob="" tsis="" tu="" ncua,="" 24="" teev="" (p="0.038)" thiab="" 48="" teev="" (p="0.003)" tsis="" mob="" tsis="" tu="" ncua,="" tus="" neeg="" mob="" lub="" siab="" pom="" kev="" hloov="" pauv="" ntawm="" 2="" teev="" (p="0.022)" 、="" rov="" ua="" txoj="" haujlwm="" tsis="" pub="" dhau="" 24="" teev="" (="" p="">

Raws li tau hais dhau los, hais txog ntawm ob qhov kev kawm ua tiav: 2 teev tom qab kev tswj hwm, piv nrog pab pawg placebo, feem ntau ntawm cov neeg mob hauv pawg AXS-07 tau ua tiav qhov mob kom zoo (19.9% ​​vs 6.7%, p< 0.001)="" thiab="" tsis="" muaj="" cov="" kev="" mob="" siab="" tshaj="" plaws="" (36.9%="" vs="" 24.4%,="" p="0.002)." hauv="" txoj="" kev="" tshawb="" fawb="" no,="" axs-07="" tau="" zoo="" siab="" thiab="" pom="" zoo.="" feem="" ntau="" cov="" kev="" phiv="" tshuaj="" ntawm="" axs-07="" yog="" xeev="" siab,="" kiv="" taub="" hau="" thiab="" tsaug="" zog.="" qhov="" xwm="" txheej="" ntawm="" cov="" tshwm="" sim="" tsis="" zoo="" no="" tsis="" siab="" tshaj="" qhov="" ntawm="" cov="" placebo="" lossis="">

Raws li cov txiaj ntsig ntawm txoj kev tshawb fawb, Axsome npaj yuav xa Daim Ntawv Thov Tshuaj Tshiab (NDA) rau AXS-07 rau kev kho mob hnyav rau mob taub hau mus rau Asmeskas Cov Khoom Noj thiab Tshuaj Noj (FDA) nyob rau plaub lub hlis xyoo 2020. Lub Plaub Hlis Ntuj xyoo no , kev kawm txog Theem III INTERCEPT (NCT04163185) ntawm AXS-07 rau kev kho thaum ntxov ntawm tus mob taub hau kuj ua tiav. Nws yuav tsum tau taw qhia tias cov neeg mob tau cuv npe hauv MOMENTUM txoj kev tshawb no yog cov neeg mob uas muaj keeb kwm tsis muaj kev kho zoo txaus, thiab kev kho mob tau muab ib zaug rau mob nyhav lossis mob hnyav txhaus mob tshwm sim. Qhov sib txawv ntawm kev kawm ntawm INTERCEPT yog tias AXS-07 tau muab tam sim ntawd thaum muaj cov tsos mob thaum ntxov tshwm sim.