HRTX

HTX-011

Postoperative pain

Report out on post-CRL FDA meeting

Exp Date

November 13, 2020 (Est)

Amp Volatility Score

35%

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)


PRIOR DATA/EVENTS


PRESS RELEASE

COMPETITORS

  • 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

MARKET

  • +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.

  • Click here to read more

Updated by HC

HRTX, HTX-011, post_operative_pain, NDA

Prior Data (click to view full image)

Chart

Trial Design / Revenue (click to view full image)

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