Heron Gains FDA Support For Nausea Drug After A Year Under Review

Xconomy San Francisco — 

The decision that Heron Therapeutics has been waiting on for almost a year is finally in: The FDA has approved the Redwood City, CA-based company’s drug for nausea and vomiting associated with certain chemotherapy regimens.

Heron (NASDAQ: HRTX) first submitted a new drug application for the treatment, granisetron (Sustol), to the FDA in September 2015. The regulatory agency extended its expected decision date three times, most recently in April. Now, with the approval in hand, Heron says it hopes to begin selling the drug in the fourth quarter of this year.

Granisetron is an extended-release, injectable drug that aims to help cancer patients—particularly those with breast cancer—deal with both immediate and delayed nausea and vomiting resulting from chemotherapy, for up to five days. The drug works to counter the side effects of a couple of the most commonly prescribed types of chemotherapy, such as anthracycline and cyclophosphamide combinations, Heron says.

The company’s stock rose about 9.8 percent from yesterday’s closing price, to $21.80, as of 9:57 a.m. in New York.

Waltham, MA-based Tesaro won approval in September 2015 for another anti-nausea drug being sold as rolapitant (Varubi), which ran into trouble after it missed clinical goals in the first two of its three late-stage trials. The company’s third attempt at a Phase 3 trial hit all of its primary and secondary goals, as Xconomy previously reported.

There are a number of other drugs that aim to aid patients with chemo-induced nausea, including Merck’s aprepitant (Emend) and palonosetron (Aloxi), which is marketed and distributed by Japanese pharmaceutical company Eisai.

In its news release, Heron says it aims to make granisetron stand out by noting its ability to potentially protect patients for up to five days. In particular, Heron says that other drugs, “including palonosetron, are generally effective for 48 hours or less.” On the palonosetron website, the drug is touted as being used to treat nausea on the day of chemo, as well as up to five days following chemotherapy.

Heron didn’t immediately respond to a request for comment on pricing of the newly approved drug.