Olinvyk is the first new chemical entity in this IV drug class in decades.
The manufacturer of a new intravenous (IV) opioid cleared by FDA to treat acute pain says it expects to get the drug to market in the fourth quarter.
FDA okayed oliceridine (Olinvyk, Trevena) for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate, Trevena said in a press release.
“We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options,” said Trevena President and CEO Carrie L. Bourdow.
However, Olinvyk will not be commercially available until the DEA issues its controlled substance schedule in around 90 days.
An opioid agonist, Olinvyk is the first new chemical entity in this IV drug class in decades “ and offers a differentiated profile that addresses a significant unmet need in the acute pain management landscape,” Trevena said.
It delivers IV opioid efficacy within two to five minutes and requires no dosage adjustments in patients with renal impairment — a large patient population with significant medical complications, Trevena noted.
Each year, approximately 45 million hospital patients in the U.S. receive an IV opioid to treat their acute pain.
“Many of these patients are complex and difficult to treat, such as the elderly, obese, or renally-impaired. Current hospital trends suggest that the number of these complex patients is growing, representing an increasing burden on the healthcare system,” Trevena said.
The FDA noted the new drug is for short-term IV use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures — not for at-home use.
“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,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a press release from FDA.
The FDA approval of Olinvyk was based on results from Trevena’s Phase 3 development program, which evaluated the medication in more than 1,500 patients with moderate to severe acute pain.
In two efficacy studies in hard- and soft-tissue surgical models, Olinvyk demonstrated rapid analgesic efficacy statistically significant versus placebo.
In a large, open-label, “real world” safety study, Olinvyk was safe and well-tolerated in a medically complex patient population, including the elderly, obese, and patients with comorbid conditions such as diabetes and sleep apnea, Trevena said.
“Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing,” said Gregory Hammer, MD, professor of anesthesiology, perioperative and pain medicineand of pediatrics at Stanford University, in the Trevena press release. “Olinvyk represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile.”
Olinvyk 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.
Unlike other opioids for IV administration, Olinvyk has a maximum recommended daily dose limit of 27 mg.