|Phase||Target||Indication||Preclinical Phase 1 Phase 2 Phase 3 NDA|
|NDA||Mu-receptor||Moderate to Severe Acute Pain||intravenous|
|TRV734||Phase 1||Mu-receptor||Moderate to Severe Pain||oral|
OLINVO™ (oliceridine) Injection was designed to optimize opioid receptor pharmacology using Trevena’s proprietary platform to deliver an improved analgesic profile compared to conventional intravenous (IV) opioids. OLINVO is the first G Protein-Biased Ligand at the μ-opioid receptor, and is in development for the management of moderate-to-severe acute pain where IV therapy is preferred.
In February 2016, the FDA granted Breakthrough Therapy status to OLINVO. This designation is granted by the FDA to new therapies intended to treat serious conditions and for which preliminary clinical evidence indicates that the drug may demonstrate substantial clinical improvement over available therapies. In January, 2018, we announced that FDA has accepted the OLINVO new drug application for review with a Prescription Drug User Fee Act review date of November 2, 2018.
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