Benzinga | Oct 30, 2020 07:46AM EDT

Trevena, Inc. Announces DEA Has Classified OLINVYK (oliceridine) Injection As A Schedule II Controlled Substance; Co. Expects To Make OLINVYK Available For Distribution In November

OLINVYK commercial supply on track and available in November

Company funded through Q4 2022, including OLINVYK commercialization

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Company to host conference call at 8:30 a.m. ET on Monday, November 2nd, 2020

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CHESTERBROOK, Pa., Oct. 30, 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 oliceridine has been classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). With DEA scheduling now complete, the Company expects to make OLINVYK available for distribution in November.

"I am pleased that OLINVYK is now an FDA approved and scheduled product -- two major milestones achieved in 2020," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "We made the decision earlier this year to begin manufacturing commercial product, so that physicians could have access to OLINVYK for their hospitalized acute pain patients as soon as possible upon approval and DEA scheduling. We look forward to making OLINVYK available for ordering in November."

Each year, approximately 45 million hospital patients in the United States receive drugs like IV morphine to treat their acute pain. OLINVYK is an IV opioid that is the first new chemical entity in this drug class in decades and is distinct from drugs like IV morphine. OLINVYK has no active metabolites and requires no dosage adjustment in renal-impaired patients, a large patient population with significant medical complications. In addition, OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action.

OLINVYK was studied in over 1,500 patients, including medically complex patients such as the elderly and obese, and across a variety of surgical procedures.

As a new chemical entity, OLINVYK was required to be scheduled by the DEA following its approval by FDA in August 2020. A Schedule II assignment applies to drugs that should only be administered by a healthcare professional in controlled clinical settings. All current IV opioids used in the hospital setting are classified as Schedule II substances.

The Company also today announced cash and cash equivalents of $112.7 million as of September 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2022.