Trevena Announces FDA Approval of OLINVYK™ (Oliceridine) Injection

OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic

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) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

OLINVYK will be commercially available when the U.S. Drug Enforcement Administration (DEA) issues its controlled substance schedule in approximately 90 days.

“The approval of OLINVYK marks an exciting step forward in Trevena’s mission of translating cutting-edge scientific discovery into therapeutic benefit for patients in need. I would like to thank all of the patients, investigators, and our employees who helped us achieve this important milestone,” said Carrie L. Bourdow, President and Chief Executive Officer.

“We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options.”

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Each year, approximately 45 million hospital patients in the United States receive an IV opioid to treat their acute pain.

Many of these patients are complex and difficult to treat, such as the elderly, obese, or renally-impaired. Current hospital trends suggest that the number of these complex patients is growing, representing an increasing burden on the healthcare system.

OLINVYK is an opioid agonist that is the first new chemical entity in this IV drug class in decades and offers a differentiated profile that addresses a significant unmet need in the acute pain management landscape.

OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action. In addition, OLINVYK requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications.

The FDA approval of OLINVYK was based on results from the Phase 3 development program, which evaluated OLINVYK in over 1,500 patients with moderate to severe acute pain.

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In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically significant vs. placebo. In a large, open-label, “real world” safety study, OLINVYK was safe and well-tolerated in a medically complex patient population, including the elderly, obese, and patients with comorbid conditions such as diabetes and sleep apnea.

“Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing,” said Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University.

“OLINVYK represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile.”

The Company expects to make OLINVYK available in the fourth quarter of 2020 following scheduling by the DEA, which may take up to 90 days.

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The Company is committed to an ethical and responsible marketing campaign for OLINVYK and will have safeguards in place to monitor for and mitigate the risk of non-medical uses of OLINVYK.

The Company also today announced $54.8 million in cash and cash equivalents as of June 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2021.

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