The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to HTX-011 (Heron Therapeutics), a novel treatment for postoperative pain management. 

HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. The treatment is designed to deliver pain relief directly to the site of tissue injury, thereby potentially reducing the need for systemically administered pain medications. The Breakthrough Therapy designation was based on results from two Phase 3 trials which showed significant reductions – compared to placebo and bupivacaine – in both pain intensity and the need for opioids during a 72-hour post-surgery period.  

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“HTX-011 is the only long-acting local anesthetic to demonstrate significantly reduced postoperative pain and opioid use through 72 hours compared to bupivacaine solution, the standard-of-care,” said Barry D. Quart, PharmD, CEO of Heron Therapeutics. 

The Company indicated that they will work towards a New Drug Application submission in the second half of 2018. 

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