Indivior's RBP-6000 recommended by US FDA Advisory Committees for opioid use disorder.
M2 PHARMA-November 1, 2017-Indivior's RBP-6000 recommended by US FDA Advisory Committees for opioid use disorder
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Pharmaceutical company Indivior PLC (LON:INDV) said on Tuesday that the US Food and Drug Administration (FDA) Advisory Committees has recommended the approval of RBP-6000 for the treatment of opioid use disorder (OUD).
The US FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to one to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD).
Additionally, the FDA will consider the Advisory Committees' non-binding recommendation in its review of the New Drug Application for the company's RBP-6000 based on the company's Phase 3 study. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 30 November 2017.
In conjunction, the company's Phase 3 study met its primary efficacy endpoint, with both RBP-6000 dosage regimens demonstrating abstinence rates that were significantly higher versus placebo (300 mg/300 mg: 41.3%; 300 mg/100 mg: 42.7%; placebo: 5.0%, p
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|Date:||Nov 1, 2017|
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