Ibuprofen, Acetaminophen, Htx-011, Bupivacaine Hydrochloride, Luer Lock Applicator
Analgesia
Phase IV
Completed
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE
Oct 25, 2023
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Ibuprofen, Acetaminophen, Htx-011, Bupivacaine Hydrochloride, Luer Lock Applicator
Postoperative Pain, Total Shoulder Arthroplasty, Multimodal Analgesia
Phase IV
Completed
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.
Oct 25, 2023
―
Ibuprofen, Acetaminophen, Htx-011, Bupivacaine Hydrochloride, Luer Lock Applicator
Analgesia
Phase IV
Unknown
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
Oct 01, 2021
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Htx-011, Bupivacaine Hcl, Luer-Lock Applicator, Vial Access Device
Postoperative Pain
Phase III
Completed
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
Sep 25, 2017
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Htx-011, Bupivacaine Hcl, Luer-Lock Applicator, Vial Access Device
Postoperative Pain
Phase III
Completed
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
Jul 31, 2017
―
Htx-011, Bupivicaine Hcl, Ropivacaine
Postoperative Pain
Phase II
Completed
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
Jan 06, 2017
―
Htx-011, Bupivacaine Hcl Without Epinephrine
Postoperative Pain
Phase II
Completed
Phase 2B Upper Extremity Nerve Block Study
Jan 03, 2017
―
Htx-011, Zynrelef
Analgesia
Phase II
Completed
HTX-011 for Post-bunionectomy Analgesia
Jun 09, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Heron Therapeutics (AXD2) have in its pipeline
AXD2 is currently developing the following drugs: Ibuprofen, Acetaminophen, Htx-011, Bupivacaine Hydrochloride, Luer Lock Applicator, Ibuprofen, Acetaminophen, Htx-011, Bupivacaine Hydrochloride, Luer Lock Applicator, Ibuprofen, Acetaminophen, Htx-011, Bupivacaine Hydrochloride, Luer Lock Applicator. These drug candidates are in various stages of clinical development as the company works toward FDA approval.