Trevena, Inc. Ceases Sale of OLINVYK Dosage Strengths

Trevena, Inc. reported in a recent 8-K filing to the Securities and Exchange Commission that as of December 31, 2024, the company has stopped the sale of the remaining dosage strengths (1 mg/mL and 2 mg/2 mL) of OLINVYK (oliceridine) injection. This decision to discontinue the sale of these dosage strengths was primarily driven by business and financial considerations and is not attributed to any concerns regarding the product’s efficacy or safety.

The halt in sales was a strategic move by Trevena and was not prompted by any specific request from the Food and Drug Administration (FDA). Trevena, a Delaware-based company, took this action independently as part of its ongoing operational strategy.

In its filing, Trevena stated that this decision was solely based on internal evaluations and did not stem from any external regulatory pressures. The company’s commitment to maintaining high standards of product integrity and compliance remains unwavering despite the recent alteration in the OLINVYK product offerings.

As a part of the filing, Trevena also disclosed that a Cover Page Interactive Data File (embedded within the Inline XBRL document) is included as an exhibit in the submission.

Carrie Bourdow, the Acting Chief Executive Officer and Principal Executive Officer of Trevena, signed off on the report on behalf of the company on January 15, 2025.

Following this development, investors and stakeholders are keen on observing how Trevena navigates its product portfolio and market positioning in the wake of this strategic decision regarding OLINVYK dosage strengths.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Trevena’s 8K filing here.

About Trevena

Trevena, Inc, a biopharmaceutical company, focuses on the development and commercialization of novel medicines for patients affected by central nervous system disorders. Its lead product candidates include OLINVYK (Oliceridine) injection, a G protein biased mu-opioid receptor (MOR) ligand for the management of moderate-to-severe acute pain; TRV250, a G protein biased delta-opioid receptor agonist for the treatment of acute migraine; TRV734, a small molecule G protein biased ligand of the MOR for the treatment of moderate-to-severe acute and chronic pain; and TRV045, a novel S1P modulator for managing chronic pain.