|Phase||Molecular Target||Therapeutic Target||Preclinical Phase 1 Phase 2 Phase 3 NDA|
|Oliceridine injection||NDA||Mu-receptor||Moderate to Severe Acute Pain||intravenous|
|TRV734||Phase 1||Mu-receptor||Moderate to Severe Pain||oral|
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. Oliceridine injection 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.
We have completed two pivotal Phase 3 efficacy studies (APOLLO 1 and APOLLO 2) of oliceridine in moderate-to-severe acute pain following bunionectomy and abdominoplasty, respectively. In both studies, all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo, as measured by responder rate. We also have completed a Phase 3 open-label safety study (ATHENA) in which 768 patients were administered oliceridine to manage pain associated with a wide range of procedures and diagnoses. In late 2017, we submitted the oliceridine new drug application, or NDA, to the United States Food and Drug Administration, or FDA. On November 2, 2018, the FDA issued a complete response letter, or CRL, with respect to our NDA for oliceridine.
Oliceridine injection is an investigational product not approved by FDA for distribution in the US.
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