FDA Approves APONVIE for Prevention of Postoperative Nausea and Vomitting

The US Food and Drug Administration (FDA) has approved aprepitant as first and only injectable emulsion for preventing nausea and vomiting after surgery among adult patients.

Administered via a single 30-second IV injection, APONVIE reaches drug levels associated with ≥97% receptor occupancy in the brain within five minutes and maintains therapeutic plasma concentrations for at least 48 hours.

APONVIE is provided in a single-dose vial that delivers the full 32 mg dose approved for PONV. This ready-to-use, easy to administer, innovative IV formulation ensures rapid and consistent exposure in patients undergoing surgery.

An important component of the FDA approval of APONVIE were results from two multicenter, randomized, double-blind clinical studies comparing oral aprepitant to current standard of care, IV ondansetron, for the prevention of PONV in patients during the 48 hours following open abdominal surgery demonstrating that aprepitant was more effective than ondansetron in preventing vomiting.

Treatment with aprepitant resulted in approximately 50% fewer patients vomiting in the first 24 and 48 hours compared to ondansetron. In clinical studies, APONVIE was well-tolerated and presented a safety profile comparable to oral aprepitant.

In a 2020 Cochrane meta-analysis, aprepitant was ranked as the most effective drug approved for PONV prophylaxis, being the most effective for the prevention of vomiting in the first 24 hours post-surgery and the drug with the fewest adverse events.

"With the approval of APONVIE our acute care portfolio now addresses the two most common concerns of patients and clinicians after surgery, postoperative pain and postoperative nausea and vomiting.

This marks an important milestone for our expanding acute care portfolio and is a testament to our ongoing commitment to developing innovative solutions to help improve the overall patient experience after surgery," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "With approximately 36 million procedures in the U.S. each year in patients with high to moderate risk for PONV, the approval of APONVIE provides an easy to use, highly effective option for these patients that fits seamlessly into our acute care franchise."

PONV are common adverse effects of anesthesia and surgery, with an estimated 30 percent of patients receiving general anesthesia and up to 80 percent of high-risk patients experiencing these symptoms, necessitating more effective preventative agents. PONV is a major cause of patient dissatisfaction after surgery, with patients frequently ranking vomiting as the most undesirable outcome of anesthesia.

Additionally, PONV presents a significant risk in outpatient surgeries as patients are often discharged within hours after surgery and no longer have access to highly effective antiemetics.

"PONV is commonly experienced after surgery and may result in increased hospital stays, prolonged recovery time, and decreased patient satisfaction" said Ashraf Habib, MBBCh, MSc, MHSc, FRCA, Chief, Division of Women's Anesthesia at Duke University Hospital.

"Oral aprepitant has been used to prevent postoperative nausea and vomiting for more than 16 years and it is exciting to see that, with the approval of APONVIE, physicians can now offer patients a more convenient IV injection that delivers the same effective treatment, with a 48-hour duration of effect, in a rapid, consistent and reliable way, ensuring a better experience for patients postoperatively."