The indication limits the new opioid to clinical setting use—no take-home prescriptions.
The US Food and Drug Administration (FDA) has approved opioid agonist oliceridine (Olinvyk) for the management of moderate to severe acute pain in adults in instances where pain is severe enough to require an intravenous (IV) opioid.
The indication, granted to Trevena, is for short-term IV use in hospitals or other controlled clinical settings including inpatient and outpatient procedures.
The FDA clarified in the approval that oliceridine is not indicated for at-home use.
Oliceridine's approval is based on findings from a 1535-patient series of controlled and open-label trials assessing its safety and efficacy versus placebo among participants who had undergone bunion surgery or abdominal surgery.
The therapy was associated decreased rates of reported pain among post-operation patients.
Investigators reported a safety profile of oliceridine similar to that of other opioids, including common side effects of nausea, vomiting, dizziness, headache, and constipation. Its use is advised against patients with significant respiratory depression, acute or severe unmonitored bronchial asthma, potential gastrointestinal obstruction, or hypersensitivity to the therapy.
Marketed Olinvyk will cary a boxed warning on its label about addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome risk, and risks from concomitant use with benzodiazepines or other central nervous system (CNS) depressants. The maximally recommended daily dose limit for oliceridine is 27 mg.
Addressing the opioid crisis, said Douglas Throckmorton, MD, FDA deputy director for regulatory programs in the Center for Drug Evaluation and Research, remains a top priority for the agency.
"We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives,” Throckmorton said in a statement. “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."
Throckmorton stressed oliceridine is strictly indicated for controlled clinical setting use, without allowance for take-home prescription.