|Phase||Target||Indication||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|
Our pipeline consists of innovative product candidates focused in areas of acute care where current options leave significant unmet medical need:
Oliceridine injection, our lead product candidate, is a next-generation IV analgesic in development for the management of moderate-to-severe acute pain. Oliceridine injection has been designated a Breakthrough Therapy by the U. S. Food and Drug Administration.
In February 2017, we announced top-line results from two Phase 3 pivotal efficacy studies testing multiple oliceridine injection dosing regimens. In both studies, all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo, as required for FDA approval. In addition, compared to a commonly used IV morphine regimen, patients given one of the tested oliceridine injection regimens experienced comparable pain relief with numerically less frequent adverse events including vomiting and multiple indicators of respiratory safety – both key unmet needs in acute pain management.
Oliceridine injection was specifically designed to improve on conventional IV opioid pharmacology by binding to the same endorphin receptor as conventional opioids and selectively activating the pathway leading to pain relief, while avoiding a pathway associated with opioid-related adverse effects. Clinical trial results have consistently suggested that oliceridine injection may provide rapid and effective pain relief while potentially setting a new standard for opioid safety and tolerability.
Our pipeline also includes several product candidates we have identified as potential best-in-class or first-in-class therapies to address a variety of serious unmet medical needs. TRV734 has completed Phase 1 studies for the oral treatment of acute and chronic pain; TRV250 is in Phase 1 development for the treatment of migraines; and TRV027 recently was evaluated in a Phase 2b study for the treatment of acute heart failure.
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