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FDA Gives Approval To Heron Drug Sustol To Prevent Chemotherapy-Induced Nausea And Vomiting

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After two failed attempts, Heron Therapeutics has finally gained the approval of federal health regulators for its long-acting injection to prevent chemotherapy-induced nausea and vomiting.

The U.S. Food and Drug Administration (FDA) on Aug. 9 approved the use of Heron's antinausea drug Sustol, marking the California-based company's first regulatory approval.

According to the National Cancer Institute, there will be about 1,685,210 new cases of cancer in the United States in 2016. The disease is also prevalent worldwide.

Chemotherapy is among the most effective and most commonly used therapies for patients diagnosed with cancer. Unfortunately, treatment of the disease comes with unwanted side effects.

Nausea and vomiting are among the most acute side effects of chemotherapy, affecting up to 80 percent of patients. Delayed nausea and vomiting, which happen between two and five days after a chemotherapy treatment, are particularly debilitating for cancer patients. These side effects are also the leading causes why patients discontinue treatment.

Treatments for chemotherapy-induced nausea and vomiting (CINV), such as Eisai's Aloxi injection, provide relief for about 48 hours or less, but Heron's newly approved drug can give patients longer-acting relief of more than five days after chemotherapy, a significant improvement compared with what is currently available.

"In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less," said Ralph Boccia, medical director of Center for Cancer and Blood Disorders. "Sustol, due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days."

Sustol is approved to be used in combination with other agents to prevent vomiting and nausea that are linked to some forms of chemotherapy excluding platinum-based regimens. The exclusion comes as a disappointment since the drug showed strong response in patients undergoing platinum-based therapy.

The exclusion of platinum-based therapy also means that the population that can be addressed by Sustol will be reduced by about 7 percent.

Common adverse reactions associated with use of the antinausea drug include headache, constipation, fatigue, diarrhea, insomnia, abdominal pain, dyspepsia, dizziness and asthenia.

Reactions that may occur in injection site following administration include pain, bleeding, infection, tenderness, nodules, induration and swelling. Some of these injection site reactions may occur two weeks or more after injection with Sustol.

Heron has not yet disclosed the price of Sustol albeit it said it would reference recently approved treatments for CINV. Industry experts estimate a price of $200 per patient.

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