TRVN - Trevena Announces Acceptance of Abstract Examining the Use of OLINVYK in Patients with Acute Burn Injuries | Benzinga
CHESTERBROOK, Pa., Nov. 30, 2023 (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, announced today the acceptance of an abstract based on the pRospective, case-controlled Evaluation of oLIceridine for moderate or sEVEre pain in patients with acute burn injuries (RELIEVE) study at the 2024 ABA annual meeting, being held April 9th-12th in Chicago. The study was conducted as an investigator-initiated trial and was led by David Hill, PharmD. from the Firefighters Burn Center in Memphis, TN. Dr. Hill was independently responsible for the development and submission of the abstract.
The single-center, prospective, case-controlled study was dual IRB approved and included 10 patients with burn injuries admitted between April and September 2023 and treated with OLINVYK. Dosing and assessments were followed per study protocol and safety and efficacy assessed by study team daily at a minimum. Patients dosed with OLINVYK were compared to a matched historical control group (N=18) which included treatment across a range of other IV opioids.
"The results of the RELIEVE study will be reported during the ABA meeting and we are pleased to see additional clinical data in this patient type where new therapeutic options are needed," stated Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. "We look forward to the presentation of these data in the spring."
Financial support and study drug for the trial was provided by Trevena. Dr. Hill has previously served as a consultant for Trevena.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains olicerdine, an opioid, which is a Schedule II controlled substance with high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the ...