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대웅 "나보타, 보톡스 대비 동등한 미간주름 개선 효과" - 바이오스펙테이터

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대웅 "나보타, 보톡스 대비 동등한 미간주름 개선 효과"

입력 2019-04-12 13:15 수정 2019-04-12 13:15

바이오스펙테이터 조정민 기자

유럽 및 캐나다 임상3상 결과 'Aesthetic Surgery Journal' 게재...미간주름 개선 효과 및 안전성에서 보톡스 대비 비열등성 입증

대웅제약이 자체 개발한 보툴리눔 톡신제제 '나보타(Prabotulinumtoxin A)'의 미간주름 개선 효과와 안전성이 보톡스와 비교해 동등하다는 연구결과가 나왔다. 대웅제약은 지난 5일 나보타의 유럽 및 캐나다 임상3상 결과가 국제학술지 '에스테틱 서저리 저널(Aesthetic Surgury Journal)'에 게재됐다고 12일 밝혔다.

이번 연구결과는 유럽 및 캐나다에서 시행한 임상3상(EVB-003)으로, 나보타와 앨러간의 보톡스를 직접 비교한 비열등 임상이다. 미간주름 척도인 GLS(Glabellar Line Scale) 2~3단계인 성인 540명을 대상으로 나보타(245명)와 보톡스(246명)를 각각 20U의 동일한 용량으로 1회 투여하고, 일정시점 이후 연구자가 피험자의 주름개선 효과를 확인하는 이중맹검 형태로 진행됐다.

1차 유효성 평가는 시술 후 30일째 측정됐다. 나보타를 투여한 군은 분석에 참여한 235명 중 205명(87.2%)과 보톡스 군의 244명 중 202명(82.8%)이 미간주름 개선 효과를 나타냈다. 또한 시술 150일 후 미간주름 증상 개선을 평가하는 GAIS(Global Aesthetic Improvement Scales)에서 미간주름이 개선됐다고 응답한 비율은 나보타 49.6%, 보톡스 41.3%였다.

이러한 결과는 나보타가 보톡스 대비 동등 이상의 결과를 보였으며 비열등성을 입증한 것이다. 약물 관련 심각한 이상사례는 보고되지 않았다.

박성수 대웅제약 나보타 사업본부장은 "보톡스 대비 비열등성을 입증한 임상연구가 국제학술지에 게재된 것은 매우 의미 있는 결과”라며 “나보타는 엘러간의 보톡스 이후 처음으로 미국시장에 진출하는 900kDa 제품으로, 임상을 통해 입증된 나보타의 우수한 효과와 안전성은 미국 현지의 의료진들과 환자들의 유인동기로 작용할 것으로 기대한다”고 밝혔다.

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