Axsome's new oral multi-mechanism drug AXS-07 nkag mus saib hauv Tebchaws Meskas--2/2

AXS-07 tuaj yeem kho mob migraine sai sai. Nyob rau txhua lub sij hawm taw tes ntsuas ntawm 15 feeb, qhov feem pua ​​​​ntawm cov neeg mob migraine nyem ntawm AXS-07 yog tus lej ntau dua li ntawmrizatriptan uapab pawg, thiab nws yog qhov txheeb xyuas ntau dua ntawm 60 feeb. Hauv pawg rizatriptan (p=0.04). Qhov feem pua ​​​​ntawm cov neeg mob uas mob nyem 1.5 teev tom qab kev tswj hwm yog 60.5% rau AXS-07, 52.5% raurizatriptan uathiab 48.3% rau cov placebo (piv nrog AXS-07, p=0.019, p=0.004, feem). AXS-07 tau zoo dua lirizatriptan uanyob rau hauv ob peb lwm cov ntsiab lus thib ob (xws li tus neeg mob' tag nrho cov kev xav ntawm kev hloov [PGI-C], p=0.022) thiab rov qab ua haujlwm li qub hauv 24 teev (p=0.027).

Hauv txoj kev tshawb no, AXS-07 muaj kev nyab xeeb thiab ua tau zoo. Feem ntau cov kev phiv tshwm sim ntawm AXS-07 yog xeev siab, kiv taub hau thiab tsaug zog. Qhov tshwm sim ntawm cov kev cuam tshuam tsis zoo no tsis siab dua li cov placebo lossis 3%. Ib qho xwm txheej tsis zoo tshwm sim hauv pawg kho mob AXS-07, uas tau suav tias tsis cuam tshuam nrog kev tshawb fawb tshuaj los ntawm tus kws tshawb fawb tshawb fawb.

INTERCEPT cov kev tshawb fawb

INTERCEPT yog ib qho randomized, ob-dig muag, ib koob tshuaj, placebo-tswj Phase III txoj kev tshawb fawb uas yog ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm AXS-07 thiab cov placebo hauv kev kho mob thaum ntxov ntawm migraine. Hauv qhov kev tshawb fawb no, 302 tus neeg mob laus tau muab tso rau ntawm qhov sib piv ntawm 1: 1. Thaum cov tsos mob ntxov tshaj plaws ntawm migraine tshwm sim thiab qhov mob hnyav tseem me me, lawv tau txais ib koob tshuaj AXS-07 lossis placebo tam sim ntawd. Ob lub ntsiab lus tseem ceeb ntawm txoj kev tshawb no yog qhov feem pua ​​​​ntawm cov neeg mob uas tsis muaj mob taub hau (mob taub hau tshem tawm) tsis pub dhau 2 teev tom qab kev tswj hwm, thiab cov feem pua ​​​​ntawm cov neeg mob uas tsis tau ntsib cov tsos mob tshwm sim feem ntau cuam tshuam nrog migraine (xeev siab, photophobia, thiab soundphobia) tsis pub dhau 2 teev tom qab kev tswj hwm. .

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb tau mus txog ob qhov tseem ceeb tshaj plaws: qhov mob nyem hauv pab pawg kho mob AXS-07 (32.6% vs 16.3%, p=0.002) thiab cov tsos mob ntxhov siab tshaj plaws (43.9% vs 26.7%, p=0.003) Kev faib ua feem ntawm cov neeg mob tau txheeb xyuas ntau dua li ntawm pawg placebo. Tsis tas li ntawd, piv nrog cov placebo pab pawg, AXS-07 pab pawg kho mob yog 2-24 teev tom qab kev tswj hwm (22.7% vs 12.6%, p=0.030) thiab 2-48 teev tom qab tswj hwm (20.5% vs 9.6%, p=0.013 ) Qhov feem pua ​​​​ntawm cov neeg mob uas tau txais kev kho mob tau txais txiaj ntsig tau nce siab dua li ntawm pawg placebo. Hauv txoj kev tshawb no, ib koob tshuaj AXS-07 sai tshem tawm cov tsos mob migraine. Hais txog kev tshem tawm qhov mob migraine thiab tshem tawm cov tsos mob uas cuam tshuam ntau tshaj plaws, kev sib cais ntawm cov placebo pib thaum ntxov tshaj 30 feeb tom qab tswj hwm, thiab ntawm 90 feeb (p=0.003) thiab txhua lub sij hawm taw tes tom qab ntawd mus txog qhov sib txawv tseem ceeb.

Tsis tas li ntawd, ib koob tshuaj AXS-07 tseem ceeb tiv thaiv tus mob migraine los ntawm kev loj hlob mus rau ntau tshaj qhov mob me me, thiab tib lub sijhawm txo qis kev siv tshuaj cawm siav. 73.5% ntawm cov neeg mob hauv pab pawg kho mob AXS-07 thiab 47.4% ntawm cov placebo pab pawg tsis muaj qhov mob tshwm sim hauv 2-24 teev tom qab kev tswj hwm (p< 0.001).="" cov="" txiaj="" ntsig="" zoo="" ntawm="" qhov="" kev="" mob="" tshwm="" sim="" tau="" muab="" txhais="" ua="" ib="" qho="" kev="" txo="" qis="" hauv="" kev="" siv="" tshuaj="" thaum="" muaj="" xwm="" txheej="" ceev.="" tsuas="" yog="" 15.3%="" ntawm="" cov="" neeg="" mob="" hauv="" pab="" pawg="" kho="" mob="" axs-07="" xav="" tau="" tshuaj="" kho="" mob="" xwm="" txheej="" ceev="" hauv="" 24="" teev="" tom="" qab="" kev="" tswj="" hwm,="" piv="" nrog="" 42.2%="" hauv="" pawg="" placebo=""><>

AXS-07 kuj tseem txo qis kev ua haujlwm tsis taus thiab pom kev txhim kho hauv tag nrho cov kab mob. 73.5% ntawm cov neeg mob hauv pab pawg kho mob AXS-07 tuaj yeem ua haujlwm li qub hauv 24 teev, piv nrog 47.4% hauv pawg placebo (p< 0.001).="" nyob="" rau="" hauv="" cov="" nqe="" lus="" ntawm="" patient="" overall="" impression="" change="" scale="" (pgi-c),="" 52.4%="" ntawm="" cov="" neeg="" mob="" hauv="" pab="" pawg="" kho="" mob="" axs-07="" thiab="" 27.7%="" hauv="" cov="" placebo="" pab="" pawg="" tau="" zoo="" heev="" los="" yog="" zoo="" dua.="">

Hauv txoj kev tshawb no, AXS-07 feem ntau muaj kev nyab xeeb thiab zam tau zoo. Feem ntau cov kev phiv tshwm sim ntawm AXS-07 yog qaug zog, kiv taub hau thiab paresthesias. Qhov tshwm sim ntawm tag nrho cov kev tsis zoo no yog tsawg dua 5%. Tsis muaj qhov tshwm sim tsis zoo hauv qhov kev sim.