WASHINGTON — Oliceridine (Olinvyk), a novel opioid agonist, won approval to manage moderate to severe acute pain in adults when pain is severe enough to require an intravenous opioid (IV) and when other treatments are inadequate, the FDA announced late Friday.
The drug is indicated for short-term IV use in hospitals or other controlled clinical settings like inpatient and outpatient procedures, not for at-home use.
The FDA will “only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a statement.
“Of note, this particular medication is only indicated for use in a controlled clinical setting, meaning under medical supervision and not for use in a take-home prescription,” he added.
Unlike other IV opioids, oliceridine has a maximum recommended daily dose limit of 27 mg.
Oliceridine is a G protein-selective agonist that targets the mu opioid receptor. It was designed to be similar to morphine in reducing pain, but with less risk of respiratory depression and gastrointestinal dysfunction.
The FDA’s advisory committee voted 8-7 against recommending approving oliceridine in October 2018, expressing concerns that low doses may not be sufficient to treat moderate to severe pain and higher doses may lead to adverse events like QT prolongation and respiratory depression.
In November 2018, the FDA issued a complete response letter requesting more information. Drugmaker Trevena re-submitted its application in February 2020, including data from a multi-dose healthy volunteer QT study, nonclinical data that confirmed levels of an inactive metabolite, and drug product validation reports. The resubmitted package also specified a maximum daily dose of 27 mg.
Oliceridine trials included 1,535 people with moderate to severe acute pain treated with the drug in controlled and open-label studies. Safety and efficacy were established in randomized, controlled studies of patients who had bunionectomy or abdominal surgery. At the approved doses, patients who received oliceridine reported decreased pain compared with placebo, the FDA said.
The drug’s safety profile was similar to other opioids: most common side effects were nausea, vomiting, dizziness, headache, and constipation. Oliceridine should not be given to patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or one without resuscitative equipment, known or suspected gastrointestinal obstruction, or known hypersensitivity to the drug, the agency warned. Using opioid analgesics for a prolonged time during pregnancy can lead to neonatal opioid withdrawal syndrome, it added.
Oliceridine carries a boxed warning about addiction, abuse and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and risks from concomitant use with benzodiazepines or other central nervous system depressants.