Approval limited to use in ’controlled clinical settings’

WASHINGTON — Oliceridine, an intravenous opioid, received FDA approval for short-term use in hospitals or “controlled clinical settings.”

The drug, which will be marketed under the brand name Olinvyk, is approved for “management of moderate to severe acute pain in adults.” It is not approved for at-home use.

In a prepared statement released with the approval announcement, Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, noted that the FDA has tightened its approval process for opioid medicines and 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. 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.”

The FDA action was based on a review of data from studies that treated a total of 1,535 patients with oliceridine. The drug’s “safety and efficacy were established by comparing Olinvyk to placebo in randomized, controlled studies of patients who had undergone bunion surgery or abdominal surgery,” the FDA explained. “Patients administered Olinvyk reported decreased pain compared to placebo at the approved doses.”

The most common side-effects of oliceridine were nausea, vomiting, dizziness, headache, and constipation—all common side-effects seen with opioids. The drug is contraindicated in patients with respiratory illness, including asthma, and should only be used in settings with available resuscitation equipment.

The drug will carry “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,” the FDA wrote. Additionally, it has a recommended daily dose limit of 27 milligrams.

The drug will be marketed by Trevena Inc.

Peggy Peck, Editor-in-Chief, BreakingMED™

Cat ID: 393

Topic ID: 392,393,393,435,662,192,725,922,925