Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use, the FDA noted in its announcement. Olinvyk will not be available for use in a hospital for at least 90 days. The U.S. Drug Enforcement Agency will be required to issue a controlled substance schedule for the new medication. Trevena anticipates the drug will be available in the fourth quarter of this year.
Carrie L. Bourdow, president and chief executive officer of Pennsylvania-based Trevena, said the company will quickly work to bring the novel IV analgesic to patients. Annually, approximately 45 million hospital patients in the United States receive an IV opioid to treat their acute pain. Many of these patients are considered difficult to treat due to complexities such as obesity or renal-related issues. Trevena said data suggests this population is increasing and represents new challenges for healthcare.
“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, professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University, said in a statement. “Olinvyk represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile.”
Olinvyk is an opioid agonist and is the first new chemical entity in this IV drug class approved over the past several decades. The drug provides a differentiated profile that addresses a significant unmet need in the acute pain management landscape, the company said. Olinvyk delivers IV opioid efficacy with a rapid 2-5 minute onset of action. In addition, Olinvyk requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications, Trevena said.
Approval of Olinvyk was based on results from a Phase III program that included two pivotal efficacy studies in hard- and soft-tissue surgical models. In the studies, Olinvyk demonstrated rapid analgesic efficacy statistically significant compared to the placebo. The drug was also shown to be safe and well-tolerated in this complex patient population.
Olinvyk carries a boxed warning regarding addiction, abuse and misuse, as well as life-threatening respiratory depression, neonatal opioid withdrawal syndrome and risks from concomitant use with benzodiazepines or other central nervous system depressants. In the wake of the opioid epidemic that has swept across the country over the past decade, Trevena said it is committed to an ethical marketing plan for the medication.