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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
OLINVYK product availability expected in fourth quarter of 2020
Company funded through year-end 2021, including OLINVYK commercialization
Company to host conference call at 8:30 a.m., today, August 10, 2020
CHESTERBROOK, Pa., August 10, 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 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.”
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 following information was filed by Trevena Inc (TRVN) on Monday, August 10, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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