Date: Jan 15, 2016 Author: Damian Garde Source: Fierce Biotech (
click here to go to the source)
Heron Therapeutics ($HRTX), pushing to finally win approval for a long-delayed treatment for chemotherapy-induced nausea, will have to wait another month or so as the FDA has put off its plans to weigh in this week.
The injected drug, Sustol, is an extended-release take on common 5-HT3 receptor blockers, widely available treatments used to combat nausea and vomiting. The FDA had promised to render a final decision on the drug by Jan. 17 but has now told Heron it needs more time, pushing the deadline to "late February," the company said.
Heron, formerly known as A.P. Pharma, has been working for years to satisfy regulators' concerns about Sustol.
The company 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 drug developer followed suit but saw its application denied again in 2013 over manufacturing and data analysis problems. The next year, A.P. Pharma rechristened itself Heron and promised to launch its top drug by early 2015, a goal derailed by issues with outside contractors, according the company.
In its most recent Phase III trial, disclosed in May, Sustol 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.
