But in the case of newly-approved drug, it can provide relief of more than five days after chemotherapy. Some of the most common adverse effects brought by the use of anti-nausea drug includes headache, constipation, fatigue, diarrhea, insomnia, abdominal pain, dyspepsia, dizziness and asthenia which is abnormal physical weakness or lack of energy. It faced its first rejection in that year and three years later it again faced rejection with regard to manufacturing and data analysis issues.
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Heron Therapeutics Inc’s twice-rejected long-acting injection to prevent chemotherapy-induced nausea and vomiting was finally approved by the U.S. Food and Drug Administration, marking the biotech’s first regulatory approval.
The treatment, however, comes with a number of side effects. The most significant challenge for my breast cancer patients receiving AC is chemotherapy-induced nausea and vomiting. Delayed nausea and vomiting is considered particularly debilitating for patients. The most frequently used MEC regimen was carboplatin/paclitaxel (31%). The National Comprehensive Cancer Network and the American Society of Clinical Oncology have categorized chemotherapy regimens based on the degree to which they cause nausea and vomiting: low emetogenic chemotherapy, MEC, and highly emetogenic chemotherapy. “Sustol represents a better option to manage this devastating side effect of therapy”.
Not having platinum-based therapies from the label is a little disappointing for the company, because Sustol has showed a good response in patients in this particular type of chemotherapy, wrote Cowen & Co’s Boris Peaker. The approval came in combination with other agents that prevent CINV, except platinum-based regimens – reducing Sustol’s addressable population by about 7 percent, company executives told Reuters.
Initial prices for the injection have not been disclosed, but Heron says it will use recently approved CINV treatments as a reference.
The novel formulation of the 5-HT3 receptor antagonist can maintain therapeutic levels of Sustol for five or more days.
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“The approval of Sustol is a major step in Heron’s evolution into a fully-integrated biopharmaceutical company with both development and commercial capabilities”, Robert H. Rosen, president of Heron Therapeutics, said in a statement.
