Intravenous analgesic oliceridine receives FDA approval for acute pain management

Intravenous analgesic oliceridine receives FDA approval for acute pain management

Oliceridine (Olinvyk), a first-in-class intravenous (IV) analgesic has recently received the US FDA approval for management of moderate to severe acute pain in adults.

The drug can be administered in cases where the pain is severe enough to require an IV opioid and when alternative treatments become inadequate.

The use of oliceridine is limited to hospitals or other controlled clinical settings, noted the agency. It is indicated for short-term use only.

Oliceridine is an opioid agonist with a rapid onset of action within two to five minutes. In addition, oliceridine requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications.

The FDA approval of oliceridine was based on results from multiple phase 3 studies that evaluated oliceridine in more than 1,500 patients with moderate to severe acute pain.

The two randomised, double-blind, placebo- and morphine-controlled studies enrolled 790 patients with moderate to severe acute pain (pain intensity of ≥4 on a 0-10 numerical rating scale) after bunionectomy or abdominoplasty.

In each study, patients were randomised to one of three oliceridine treatment regimens: a placebo-controlled regimen, or a morphine-controlled regimen. The loading dose for all oliceridine treatment regimens was 1.5 mg and demand doses were 0.1, 0.35 or 0.5 mg, according to the assigned treatment group; supplemental doses were 0.75 mg.

A lockout interval of six minutes was used for all patient-controlled analgesic (PCA) regimens. Patients who were administered oliceridine doses of 0.35 and 0.5 mg had a significantly greater summed pain intensity difference (SPID-48/24) scores than patients who used a placebo.

The patients who underwent bunionectomy or abdominoplasty reported rapid analgesic efficacy from oliceridine that was statistically significant over placebo.

In an open-label safety study of patients with moderate to severe acute pain following a surgical procedure or due to a medical condition, a total of 768 patients received at least one dose of oliceridine.

Oliceridine was administered via clinician-administered bolus dosing, patient-controlled analgesia (PCA), or a combination of the two. Bolus dosing was initiated at 1 to 2 mg, with supplemental doses of 1 to 3 mg every one to three hours, as needed, based on individual patient need and previous response to oliceridine. If oliceridine was administered via PCA, the loading dose was 1.5 mg, the demand dose was 0.5 mg, and the lockout interval was six minutes. Supplemental doses of 1 mg were given as needed, considering the patient’s use of PCA demand doses, the individual patient need and previous response to oliceridine.

The most frequent condition treated in the open-label safety study was postsurgical acute pain, and included orthopedic, gynecologic, colorectal, general, plastic, urologic, neurologic (including spinal), bariatric and cardiothoracic surgical procedures.

Of the 768 patients treated with oliceridine, 32% were aged 65 years or older and 78% had a BMI of at least 25 kg/m2. Oliceridine was administered as needed; 55% of patients received oliceridine via clinician bolus administration only, and 45% of patients received oliceridine via PCA self-administration or a combination of clinician bolus and PCA self-administration.

The safety profile of oliceridine was similar to other opioids. As with other opioids, the most common side effects of oliceridine were nausea, vomiting, dizziness, headache and constipation.

Oliceridine should not be given to 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. IV oliceridine has a maximum recommended daily dose limit of 27 mg. Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.

Oliceridine 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.