178 0 Kommentare Trevena, Inc. Announces Publication Highlighting GI Tolerability Profile of OLINVYK (oliceridine) injection in Pain and Therapy

OLINVYK significantly reduced risk of vomiting and rescue antiemetic use compared to IV morphine in a retrospective analysis

CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled “Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials,” with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x).

The results of this analysis highlight an improved gastrointestinal (GI) tolerability profile, with OLINVYK demonstrating a ~2-3x likelihood of achieving a “complete GI response” compared to IV morphine under equianalgesic conditions. A complete GI response is defined as the proportion of patients who complete the study without vomiting and without using any antiemetics.

“There are multiple types of procedures where post-operative nausea or vomiting can disrupt the integrity of a surgery, posing a significant challenge to a patient’s recovery,” said Tim Beard, M.D. “Based on the results of this analysis, OLINVYK has the potential to greatly reduce the risk of nausea and vomiting following surgery, compared to IV morphine. These are compelling findings that suggest the clinical advantages OLINVYK may offer in the post-operative acute care setting.”

Publication Key Points:

Orthopedic surgery-bunionectomy study: A higher proportion of patients achieved ‘complete GI response’ with all OLINVYK treatment regimens (0.1 mg: 76.3%; 0.35 mg: 53.2%; 0.5 mg: 49.4%) compared to IV morphine (32.9%; p < 0.05 for all 3 OLINVYK dose regimens).
Plastic surgery-abdominoplasty study: A higher proportion of patients achieved ‘complete GI response’ with all OLINVYK treatment regimens (0.1 mg: 59.7%; 0.35 mg: 39.2%; 0.5 mg: 29.9%) compared to IV morphine (28.8%; p ≤ 0.0001 for OLINVYK 0.1 mg).
Pooled data from both trials: There was a statistically significantly higher rate of ‘complete GI response’ associated with OLINVYK 0.1 mg (68%) and 0.35 mg (46.2%) compared to IV morphine (30.8%; p ≤ 0.005).
Under equianalgesic conditions: Where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, patients were 3.1x more likely to achieve a ‘complete GI response’ with OLINVYK than IV morphine in the orthopedic surgery-bunionectomy study (95% CI: 1.78, 5.56; p <0.0001), and 1.9x more likely in the plastic-surgery abdominoplasty study (95% CI: 1.09, 3.36; p = 0.024).