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New Drugs Approved In August

Olinvyk
Olinvyk

The FDA gave thumbs-up to Olinvyk (oliceridine) developed by Trevena, Inc. (TRVN) on August 7, 2020, for the management of acute pain in adults, severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate

Olinvyk is an opioid agonist that delivers IV opioid, with a rapid onset of action- 2-5 minutes, and does not need any dosage adjustments in patients with renal impairment, a large patient population with significant medical complications.

Trevena expects to launch Olinvyk in the fourth quarter of this year following scheduling by the Drug Enforcement Administration, which usually takes about 90 days.

Since the drug contains controlled substance scheduling by the DEA is required before launching in the market. A drug is scheduled depending upon its potential to abuse. A schedule 1 drug has the highest abuse rate.