After its expected FDA decision date last week came and went and its shares drove downward premarket Monday morning, Heron Therapeutics has been handed a complete response letter from the FDA.
The rejection is for its troubled drug HTX-011, a long-acting formulation of a bupivacaine solution combined with anti-inflammatory medication meloxicam. In several trials released over the past few years, the drug has shown it can significantly reduce pain intensity and decrease opioid use for 72 hours after surgery.
