HRTX - Heron Therapeutics resubmits US application for HTX-011 in postop pain

Based on outcome and final minutes of a Type A End- of-Review meeting with FDA in September, Heron Therapeutics (HRTX) has refiled marketing application with the FDA seeking approval for HTX-011 for management of postoperative pain.The submission is classified as a Class 2 resubmission, which means that the FDA can take up to 6 months to review the new information.Earlier in June this year, the FDA rejected the application citing need for additional non-clinical information. There are four non-clinical issues, three relate to confirming exposure of excipients in preclinical reproductive toxicology studies and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity.Heron generated data showing that peak plasma levels of excipients in reproductive toxicology studies are >50- to >200-fold higher than the levels observed in patients receiving the highest dose of HTX-011. The FDA also agreed with the change to the manufacturing specification proposed by Heron to

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Heron Therapeutics resubmits US application for HTX-011 in postop pain