Heron Therapeutics is gearing up for a third attempt at FDA approval for its chemotherapy-induced nausea and vomiting drug, posting a Phase III success after repeated delays.
The injected drug, Sustol, is an extended-release take on common 5-HT3 receptor blockers, widely available treatments used to combat nausea and vomiting. In a Phase III trial on 942 patients undergoing chemo, Heron's treatment beat out a generic 5-HT3 antagonist, meeting its primary endpoint of significantly increasing the number of patients who neither vomited nor needed rescue medications within 5 days of chemo.
Heron tested a combination of Sustol and two standard-of-care nausea treatments against a cocktail of the 5-HT3 blocker ondansetron and the same two agents, hitting its main goal and coming through on secondary endpoints of limiting nausea and improving patient-reported quality of life, the company said.
Now Heron is on track to resubmit the injection in the middle of this year, CEO Barry Quart said. And the positive results sent Heron's shares up about 40% overnight as investors bet the company can finally secure FDA approval after a pair of regulatory setbacks and a string of clinical delays.
Heron, formerly known as A.P. Pharma, endured its first Sustol rejection in 2010, when regulators took issue with the company's bioavailability and metabolism data and ordered it to carry out new studies. The biotech did just that but saw its application struck down again three years later over manufacturing and data analysis problems. Come 2014, A.P. Pharma rechristened itself Heron and promised to launch its lead asset by early 2015, a goal derailed by more issues with outside contractors, the company said.
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