Brief: Camurus Announces FDA Approval Of Brixadi For The Treatment Of Moderate To Severe Opioid Use Disorder

Camurus AB

23/05/2023 19:33

May 23 (Reuters) - Camurus AB  CAMX.ST :
    * CAMURUS ANNOUNCES FDA APPROVAL OF BRIXADI™ FOR THE
TREATMENT OF
MODERATE TO SEVERE OPIOID USE DISORDER
    * PRODUCT WILL BE MARKETED IN US BY CAMURUS' LICENSEE
BRAEBURN
    * FDA APPROVAL OF BRIXADI TRIGGERS USD 35 MILLION IN
MILESTONE
REVENUE TO CAMURUS FROM BRAEBURN
    * PIVOTAL TRIAL MET PRIMARY ENDPOINT OF NON-INFERIORITY FOR
RESPONDER RATE (P<0.001)
    * TRIAL MET FIRST SECONDARY ENDPOINT OF SUPERIORITY FOR
REDUCTION
OF OVERALL ILLICIT USE FROM WEEK 4 THROUGH WEEK 24 (P=0.004)
    * BRIXADI PRODUCT DEMONSTRATED RAPID AND PROLONGED REDUCTION
OF
WITHDRAWAL AND CRAVINGS, AND BLOCKADE OF OPIOID DRUG LIKING
    * SAFETY PROFILE OF BRIXADI WAS CONSISTENT WITH KNOWN SAFETY
PROFILE OF SL BPN EXCEPT FOR MILD TO MODERATE INJECTION SITE
REACTIONS

Source text for Eikon:  ID:nWkr1XsSP8 
Further company coverage:  CAMX.ST 

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