Third time’s the charm: Heron finally nabs FDA approval for antinausea drug

Heron Therapeutics ($HRTX) has gained an FDA approval for its long-acting antinausea drug Sustol. This comes after about 6 years of regulatory back-and-forth.

The drug is expected to offer patients longer-acting relief after chemotherapy, for more than 5 days, which is an improvement upon what is currently available. It’s approved to be used with some of the most commonly prescribed--and highly nausea-inducing--chemotherapy regimens.

Wall Street warmed to the news, sending shares up more than 10% in early trading so that Heron hit a market cap of more than $800 million. But its share price still remains well below 52-week highs.

"The Sustol clinical trial populations and results are highly representative of cancer patients in our real-world clinical practice,” said Dr. Jeffrey Vacirca, CEO and director of clinical research at North Shore Hematology Oncology Associates and VP of the Community Oncology Alliance, in a statement.

The newly approved drug can be used in combination with other antiemetics with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

Added Vacirca, “Use of MEC regimens is widespread, and AC-based regimens are among the most commonly prescribed highly emetogenic chemotherapy regimens. The most significant challenge for my breast cancer patients receiving AC is chemotherapy-induced nausea and vomiting. Sustol represents a better option to manage this devastating side effect of therapy.”

Sustol (granisetron) had been rejected twice previously by the agency in a tale that reaches back to 2010. Heron, then known as A.P. Pharma, had its first FDA rejection for Sustol then; it was asked to carry out additional testing. Then it came back with the data, but three years later it was rejected on manufacturing and data analysis issues.

The company was rechristened Heron in 2014 with hopes of launching Sustol in early 2015. Now, that goal looks to finally be a reality; the company expects to start selling it in the U.S. during the fourth quarter.

Sustol is an extended-release, injectable 5-HT3 receptor antagonist. It’s based on Heron’s Biochronomer polymer-based drug delivery technology, which is used to maintain therapeutic levels of granisetron for more than 5 days. That would cover both the acute and the delayed phases of chemotherapy-induced nausea and vomiting (CINV).

“Despite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,” said Dr. Ralph Boccia, medical director at the Center for Cancer and Blood Disorders, in the release. “In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less. Sustol represents a novel option that can protect patients from CINV for a full 5 days.”

- here is the release

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