Report out on post-CRL FDA meeting
November 13, 2020 (Est)
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Catalyst Info & Data Links
TITLE: HTX-011 in Postoperative pain - post-CRL FDA meeting
WHAT IS THE CATALYST EVENT?
Post-CRL FDA meeting
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
November 13, 2020 (estimated: Update in HRTX quarterly SEC filing and press release)
02-19-2020 FDA Extension of Review Period for NDA
10-01-2019 Resubmits New Drug Application to FDA
12-31-2018 FDA Grants Priority Review Designation
10-31-2018 FDA Submission of HTX-011 NDA
2017: HTX-011, a proprietary, extended-release synergistic combination of bupivacaine and meloxicam for the relief of acute postoperative pain (Annual Regional Anesthesiology and Acute Pain Medicine)
2019: Opioid-free Postoperative Recovery in Patients Undergoing Herniorrhaphy (American Society of Health-System Pharmacists (ASHP)
2020: Phase 3b open-label study in total knee arthroplasty (Orthopedics Today)
May 2020: Heron Therapeutics Update (slide 3)
MARCAINE (bupivacaine, marketed by Hospira, Inc.) and generic forms of bupivacaine
NAROPIN (ropivacaine, marketed by Fresenius Kabi USA, LLC) and generic forms of ropivacaine
EXPAREL ® (bupivacaine liposome injectable suspension, marketed by Pacira Pharmaceuticals, Inc.)
ON-Q Avanos post-surgical pumps
+30M annual U.S. surgical procedures requiring postoperative pain management
Source: 2020 Heron Therapeutics Leerink Update (slide 12)
MECHANISM OF ACTION
Long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of postoperative pain.
Bupivacaine blocks the firing of local pain receptors at the surgical site, while meloxicam works in synergy to reduce local inflammation at the surgical site.
Combining both modalities in a long-acting, locally applied formulation may offer enhanced pain relief for patients relative to currently marketed interventions for postoperative pain, while at the same time reducing the dependence on opioid pain medications.
Updated by HC
HRTX, HTX-011, post_operative_pain, NDA
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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