CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, announced publication of APOLLO-2 (pivotal Phase 3) results in Pain Practice on the effects of oliceridine (TRV130) for management of moderate-to-severe acute pain following abdominoplasty.
The publication: “APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the µ-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty”, with lead author, Neil Singla, M.D., CEO of Lotus Clinical Research, is available online at https://doi.org/10.1111/papr.12801.
“IV opioids remain an important option for physicians in managing post-surgical moderate to severe acute pain for a subset of patients. In this study, oliceridine provided statistically superior pain relief compared to placebo, with a rapid onset of action and a favorable safety profile,” said Dr. Singla. “These results are consistent with those seen in the APOLLO-1 pivotal Phase 3 study in bunionectomy patients, suggesting that oliceridine is efficacious and well-tolerated, and could provide pain relief for patients with moderate to severe acute pain.”
Study Summary and Key findings:
- In APOLLO-2, a Phase 3 randomized, double-blind, placebo- and active-controlled clinical study, 401 patients were administered either oliceridine, morphine, or placebo intravenously (IV) for 24 hours following abdominoplasty.
- There were three dosing regimens for oliceridine (0.1mg, 0.35mg, and 0.5mg) and one for morphine (1mg), each self-administered by the patient as needed to control their pain.
- The primary endpoint of the study was achieved: the proportion of treatment responders in all the oliceridine treatment regimens was statistically significantly superior to placebo.
- Findings showed that the onset of analgesia with oliceridine was rapid, and the proportion of treatment responders in the two higher oliceridine dosing regimens was similar to patients receiving morphine.
- The most commonly reported adverse events (AEs) in the study were nausea, vomiting, somnolence, and headache.
- The proportion of patients experiencing a respiratory safety event was lower in all oliceridine treatment groups compared to morphine, though this difference did not reach statistical significance.
- The efficacy, safety and tolerability data from this study are consistent with those seen in prior published clinical studies of IV oliceridine and suggest that oliceridine may represent an important new therapeutic alternative for the treatment of patients with moderate-to-severe acute pain where an IV opioid is warranted.
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA, 19087
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