This breakthrough therapy may take post-surgery pain away
Trevena Inc.’s lead drug candidate oliceridine, aimed for nonopioid pain treatment bagged the celebrated Breakthrough Therapy designation from U. S. Food and Drug Administration (FDA).
Oliceridine (TRV130) is an intravenous G protein biased ligand that targets the Mu-receptor (mechanism of action is similar to morphine and fentanyl, both are strong opioids) for treatment of moderate to severe pain.
TRV130 mechanism hypothesis (Photo credit: Trevena, Inc. official website)
Breakthrough Therapy designation is bestowed on those drugs or combination of drugs which shows promising results in preclinical studies in the treatment of serious or life-threatening conditions and needs approval for their speeding development.
Maxine Gowen, Ph.D., chief executive officer said “There is an urgent need for a novel analgesic that delivers powerful pain relief with improved safety and tolerability. We believe this designation recognizes our promising Phase 2 study data for oliceridine, which showed encouraging differentiation from morphine. We look forward to working even more closely with the FDA to facilitate our development of oliceridine.”
After two successful Phase II studies in which oliceridine was found to be equally effective as morphine for post-surgery patients and scoring substantially lower rates of side effects like nausea, vomiting and other respiratory and gastrointestinal problems, the oliceridine (TRV130) Phase 3 clinical program has been launched with the enlistment of the patients for Phase 3 ATHENA-1 study. This program will look into the safety profile and tolerance of the patients for the drug who suffers from moderate to severe pain in different clinical settings.
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