Heron scoops approval for IV postoperative nausea treatment

By Ben Hargreaves

- Last updated on GMT

Related tags: Fda, Food and drug administration, Drug approval, intravenous

Heron Therapeutics receives approval for its intravenous (IV) injection version of aprepitant, which had previously only been delivered orally.

The US Food and Drug Administration (FDA) approved Aponvie (aprepitant) for IV use for the prevention of postoperative nausea and vomiting (PONV) in adults. Heron has formulated the treatment as an injectable emulsion, which allows the drug to be delivered via a single 30-second injection.

The treatment becomes the first and only IV formulation of aprepitant for this indication. In randomized, double-blinded trials, standard oral aprepitant was shown to result in approximately 50% fewer patients vomiting in the first 24 and 48 hours compared to ondansetron, the current standard of care.

Heron noted that Aponvie proved in clinical studies to be well-tolerated and to provide a safety profile comparable to the oral version of the treatment.  Aprepitant is classified as an NK1 antagonist because it blocks signals produced by NK1 receptors, therefore decreasing the likelihood of vomiting and nausea in patients.

The Aponvie formulation reaches greater than 97% receptor occupancy in the brain within five minutes of delivery, with therapeutic plasma concentrations being maintained for at least 48 hours after injection.

According to the company, approximately 30% of patients receiving general anaesthesia and up to 80% of high risk patients will develop symptoms of PONV. Barry Quart, CEO of Heron, stated, “With approximately 36 million procedures in the US 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.”

The acute care portfolio of Heron comprises Zynrelef (bupivacaine and meloxicam), an extended-release local anaesthetic, and HTX-034, a potential treatment for postoperative pain management in Phase II clinical trials.

The other products contained within Heron’s oncology care solutions include, Sustol (ganisetrom), an approved extended-release injection for chemotherapy-induced nausea and vomiting prevention. Likewise, the company has also received the same indication approval for aprepitant formulated as an injectable emulsion, with the product known as Cinvanti.

During last month’s second quarter update, on an investor call, Quart stated that the company is ‘going after’ the approximately 500,000 units of oral aprepitant that are prescribed each year. He added that he expects Aponvie to “take a significant portion of that oral market and then expand beyond that.”

In terms of manufacturing, Heron outsources the manufacture to another unspecified company, which also produces its Cinvanti product. Quart confirmed on the investor call that there should be no issues in manufacturing at commercial scale, as the company has already sold over two million vials of the same formulation, in the form of Cinvanti.

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