Trevena Announces Publication Highlighting Risk / Benefit Analysis of OLINVYK in Pain and Therapy

Trevena

CHESTERBROOK, PA —Trevena, Inc. (Nasdaq: TRVN) this week announced the publication of an exploratory analysis evaluating the safety of OLINVYK (oliceridine) injection and IV morphine, using data from the OLINVYK Phase 3 program. The findings suggest that under equianalgesic conditions, patients receiving OLINVYK were less likely to experience adverse events (AEs) compared to patients treated with morphine.

The publication is titled, “Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials,” with lead author Gregory B. Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University (DOI: https://doi.org/10.1007/s40122-021-00299-0).

“IV opioids continue to play a key role in post-operative pain management in my practice. As clinicians, we are always focused on achieving the optimal balance of analgesia with minimal risks to our patients,” said Dr. Hammer. “These findings provide useful insight into the benefit-risk profile of OLINVYK and suggest that it can provide morphine-level pain relief with a lower risk of adverse events.”

Publication Key Points:

A logistic regression analysis of data from the two OLINVYK Phase 3 pivotal trials suggested that, at equal levels of analgesia comparing OLINVYK to IV morphine:

  • OLINVYK-treated patients were ~50% less likely than morphine-treated patients to experience one or more treatment-emergent AEs of nausea, vomiting, sedation, dizziness, pruritus, or hypoxia.
  • The odds ratio (OR) for a comparison of the effect of treatment with OLINVYK versus morphine was 0.507 for the pooled hard- and soft-tissue studies data (p = 0.009). An OR <1 indicates a lower likelihood of achieving the safety composite endpoint associated with OLINVYK treatment versus morphine. The OR was 0.499 (p = 0.042) and 0.542 (p = 0.121) for the hard-tissue and soft-tissue studies, respectively.
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The publication can be found at https://www.trevena.com/publications.

“The findings from this analysis are compelling and suggest that OLINVYK may offer an improved benefit / risk profile for patients requiring IV opioids,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. “Because all opioids carry risks, when prescribing OLINVYK, physicians should monitor their patients closely and refer to the Important Safety Information.”

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