FDA delays decision on Heron's nausea drug

Reuters Health Information: FDA delays decision on Heron's nausea drug

FDA delays decision on Heron's nausea drug

Last Updated: 2016-01-15

By Reuters Staff

(Reuters) - Heron Therapeutics Inc said the U.S. Food and Drug Administration had postponed a decision on its injectable drug to treat chemotherapy-induced nausea.

The FDA is now expected to decide on Sustol (granisetron) by late February instead of the earlier deadline of Sunday, Heron said on Friday.

Sustol succeeded in a late-stage study that tested the drug against GlaxoSmithKline Plc's anti-nausea drug, Zofran (ondansetron). Both the drugs were tested in combination with two standard-of-care nausea treatments.

Chemotherapy-induced nausea and vomiting (CINV), considered one of the most acute side effects of cancer therapy, occurs in up to 80 percent of patients, according to the National Institute of Health.

Heron is testing another drug for CINV. The company has two other experimental drugs aimed at treating chronic pain.

The Redwood City, California-based company's shares closed at $23.22 on Thursday.

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