Heron Therapeutics, Inc. says the U.S. Meals and Drug Administration (FDA) has permitted APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.
APONVIE is the primary and solely IV formulation of aprepitant for PONV prevention. Administered by way of a single 30-second IV injection, APONVIE reaches drug ranges related to 97% or extra receptor occupancy within the mind inside 5 minutes and maintains therapeutic plasma concentrations for a minimum of 48 hours.
APONVIE is offered in a single-dose vial that delivers the complete 32 mg dose permitted for PONV. The corporate mentioned the ready-to-use, simple to manage, IV formulation ensures fast and constant publicity in sufferers present process surgical procedure.
An necessary part of the FDA approval of APONVIE was outcomes from two multicenter, randomized, double-blind medical research evaluating oral aprepitant to present commonplace of care, IV ondansetron, for the prevention of PONV in sufferers through the 48 hours following open stomach surgical procedure. This demonstrated that aprepitant was simpler than ondansetron in stopping vomiting.
Remedy with aprepitant resulted in roughly 50% fewer sufferers vomiting within the first 24 and 48 hours in comparison with ondansetron. In medical research, APONVIE was well-tolerated and offered a security profile akin to oral aprepitant.
In a 2020 Cochrane meta-analysis, aprepitant was ranked as the simplest drug permitted for PONV prophylaxis, being the simplest for the prevention of vomiting within the first 24 hours post-surgery and the drug with the fewest adversarial occasions.
“With the approval of APONVIE our acute care portfolio now addresses the 2 commonest considerations of sufferers and clinicians after surgical procedure, postoperative ache and postoperative nausea and vomiting. This marks an necessary milestone for our increasing acute care portfolio and is a testomony to our ongoing dedication to creating revolutionary options to assist enhance the general affected person expertise after surgical procedure,” mentioned Barry Quart, chairman and chief government officer of Heron.
“With roughly 36 million procedures within the U.S. annually in sufferers with excessive to reasonable danger for PONV, the approval of APONVIE supplies a straightforward to make use of, extremely efficient possibility for these sufferers that matches seamlessly into our acute care franchise.”
PONV is a standard adversarial impact of anesthesia and surgical procedure, with an estimated 30% of sufferers receiving common anesthesia and as much as 80% of high-risk sufferers experiencing these signs, necessitating simpler preventative brokers.
PONV is a significant explanation for affected person dissatisfaction after surgical procedure, with sufferers incessantly rating vomiting as probably the most undesirable final result of anesthesia. Moreover, PONV presents a big danger in outpatient surgical procedures as sufferers are sometimes discharged inside hours after surgical procedure and now not have entry to extremely efficient antiemetics.
“PONV is usually skilled after surgical procedure and will end in elevated hospital stays, extended restoration time, and decreased affected person satisfaction” mentioned Ashraf Habib, chief, Division of Ladies’s Anesthesia at Duke College Hospital.
“Oral aprepitant has been used to forestall postoperative nausea and vomiting for greater than 16 years and it’s thrilling to see that, with the approval of APONVIE, physicians can now supply sufferers a extra handy IV injection that delivers the identical efficient remedy, with a 48-hour period of impact, in a fast, constant and dependable approach, making certain a greater expertise for sufferers postoperatively.”