Lub Koomhaum European Tshaj Tawm Pom Zoo Tshiab Tshiab-Kev Ua Si Analgesic Zynrelef (bupivacaine / meloxicam)

Heron Kev Kho Mob yog lub tuam txhab ua lag luam biotechnology kev lag luam tsom mus rau kev tsim cov tshuaj zoo tshaj plaws kom tau raws li qee qhov tseem ceeb tshaj plaws kev kho mob uas tsis tseem ceeb. Tsis ntev los no, lub tuam txhab tshaj tawm tias European Commission (EC) tau pom zoo Zynrelef (yav dhau los hu ua HTX-011, bupivacaine / meloxicam) rau kev kho mob tom qab mob mob los ntawm qhov mob me thiab nruab nrab phais mob hauv cov neeg laus. Heron xav kom tso Zynrelef hauv EU lag luam xyoo 2021.

Zynrelef (HTX-011) yog qhov tshiab, tsis-opioid analgesic. Nws yog ib qho kev ua yeeb yaj kiab ob qho kev sib txuas, ruaj ntseg tshuaj ua ke ntawm cov tshuaj loog hauv zos bupivacaine thiab cov tshuaj tiv thaiv tsis muaj tshuaj ntau dua tshuaj meloxicam. Cov koob tshuaj sib txuam ua ke, tsim tshwj xeeb rau kev tswj hwm ib leeg ntawm chaw kho kom zoo rau kev kho mob tom qab mob thiab o.

Cov tshuaj yog tsim los siv Heron cov tswv yim Biochronomer xa tshuab thev naus laus zis. Nws muab cov mob zoo heev los ntawm ncaj qha muab cov kev ua kom muaj zog ntau yam tshuaj loog thiab cov tshuaj tiv thaiv kab mob hauv zos mus rau qhov chaw raug mob nqaij, thaum txo qhov kev xav tau rau kev tswj hwm system (systemic). Kev thov rau kev siv tshuaj tua kab mob (xws li opioids), opioids muaj cov kev mob tshwm sim tsis zoo, kev tsim txom thiab quav ntxiv.

Nws tsim nyog hais tias Zynrelef yog thawj zaug ua yeeb yam ntev ntev, kev txhawb nqa-tso lub tshuaj loog hauv zos: hauv kev kawm qib III, nws tau raug pov thawj los piv rau cov qauv kev saib xyuas tam sim no rau kev saib xyuas qhov mob tom qab, qhov tshuaj loog hauv zos bupivacaine daws, uas tuaj yeem kawg ntev txog 72 teev Qhov tseem ceeb txo qis qhov mob thiab siv opioid.

Hauv Tebchaws Meskas, FDA tau muab tsab ntawv teb tiav (CRL) rau Daim Ntawv Thov Tshuaj Yeeb Tshuaj Tshiab (NDA) rau Zynrelef rau kev tswj hwm ntawm kev mob nraub qaum thaum xaus lub Rau Hli xyoo no. Cov ntsiab lus koom nrog cov ntaub ntawv tsis yog tshuaj saib xyuas. Tsis muaj teeb meem kev nyab xeeb lossis kev ua haujlwm tau pom, thiab tsis pom muaj teeb meem kev nyab xeeb lossis kev ua tau zoo. Tshawb nrhiav cov teeb meem txog chemical, kev tsim khoom thiab kev tswj hwm (CMC). Yav dhau los, FDA tau tso cai Zynrelef nrawm taug qab kev tsim nyog thiab txhawm rau tsim nyog tshuaj.

Biochronomer kev xa tawm tshuab (duab duab: Lub vev xaib tshuaj Heron)

Zynrelef pom zoo los ntawm European Union, raws li kev soj ntsuam 2 ntu III cov kev tshawb fawb soj ntsuam. Ob txoj kev tshawb no tau ua tiav qhov kawg thiab tag nrho 4 lub ntsiab lus tseem ceeb theem nrab. Cov ntaub ntawv pom tau hais tias hauv kev tswj qhov mob tom qab, Zynrelef pom tias txo qis qhov mob thiab opioid siv tsis pub dhau 72 teev piv nrog bupivacaine tov (tam sim no tus qauv kev kho mob ua kom zoo rau kev mob tom qab mob). Zynrelef txo qis qhov mob hnyav nyob hauv 72 teev tom qab kev phais mob, txo qis kev siv opioids tom qab kev phais mob, thiab qhov nce ntawm cov neeg mob tsis xav opioids tom qab phais. Hauv ob txoj kev tshawb nrhiav no, Zynrelef feem ntau ua tau zoo thiab nws muaj kev nyab xeeb piv rau cov tshuaj placebo thiab bupivacaine.

Tswj kev mob tom qab mob tseem yog ib qho kev nyuaj rau ntau tus kws kho mob, vim tias 80% ntawm cov neeg mob nyob hauv Europe yuav ntsib txoj kev mob ib nrab mus rau mob heev tom qab ob peb hnub tom qab kev phais. Tom qab mob tas yuav ua rau mob, ntev pw hauv tsev kho mob, thiab cov nqi kho mob siab dua. Cov ntaub ntawv soj ntsuam qhia tau tias Zynrelef ua tau zoo ntawm kev tswj hwm tus mob tom qab zoo. Qhov kev pom zoo no yuav ua rau cov kws phais neeg tuaj yeem siv cov khoom hauv ntau cov haujlwm, kom cov neeg mob feem ntau tuaj yeem tau txais txiaj ntsig ntev ntev los ntawm cov khoom tseem ceeb no.

Barry Quart, Thawj Tswj Hwm thiab CEO ntawm Heron, tau hais tias:" Kev pom zoo ntawm Zynrelef hauv EU yog qhov tseem ceeb rau Heron thiab ntau lab tus neeg mob phais mob hauv Tebchaws Europe. Zynrelef muaj qhov tshiab ntawm kev siv tshuab ntawm ob leeg thiab ib leeg, rab koob tsis pub ua daim ntawv thov. Nws yog qhov ua pov thawj hais tias Zynrelef yog qhov zoo dua li kev kho mob cov tshuaj bupivacaine hauv kev kho mob hnyav hauv 72 teev. Peb ntseeg tias Zynrelef yuav ntxiv cov kev kho mob zoo rau cov neeg mob tsim nyog los tswj cov mob tom qab.