The US Food and Drug Administration (FDA) has approved the intravenous (IV) opioid oliceridine (Olinvyk) for the management of moderate to severe acute pain in adults who require an IV opioid and for whom alternative treatments fail.
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee narrowly voted against approving oliceridine in October 2018. One month later, the FDA declined to approve the drug and requested more safety data.
"Addressing the opioid crisis remains a top priority for the FDA," Douglas Throckmorton, MD, with the FDA's Center for Drug Evaluation and Research, said in a statement announcing the approval.
"Importantly, 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. 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," Throckmorton said.
IV oliceridine was evaluated in randomized, placebo-controlled, and open-label trials involving 1535 patients with moderate to severe acute pain who had undergone bunion surgery or abdominal surgery.
At the approved doses, patients who were administered oliceridine reported decreased pain compared with patients who received placebo, the FDA said.
The label recommends using the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Dosing should be individualized on the basis of the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
The starting dose is 1.5 mg. For patient-controlled analgesia, the recommended demand dose is 0.35 mg, with a 6-minute lockout. A demand dose of 0.5 mg may be considered.
Oliceridine delivers IV opioid efficacy with an onset of action within 2 to 5 minutes and requires no dose adjustments in patients with renal impairment, Trevena said in a press release.
The drug is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction; or known hypersensitivity to the drug. Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.
Oliceridine 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.
"Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing," Gregory Hammer, MD, professor of anesthesiology and perioperative and pain medicine and of pediatrics at Stanford University, Stanford, California, said in the company's release.
"Olinvyk represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile," Hammer added.
Full prescribing information is described online. The company expects oliceridine to be available later this year.
Cite this: FDA Approves IV Opioid Oliceridine for Short-term Use - Medscape - Aug 10, 2020.