Trial Outcomes & Findings for Bunionectomy Study for Postoperative Analgesia (EPOCH 1) (NCT NCT03295721)

Last Updated: 2025-03-07

Results Overview

Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

412 participants

Primary outcome timeframe

72 hours

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group 1: HTX-011 HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo Saline placebo by instillation.	Treatment Group 3: Bupivacaine HCI Bupivacaine HCl without epinephrine, 50 mg by injection.
Overall Study STARTED	157	100	155
Overall Study COMPLETED	154	99	152
Overall Study NOT COMPLETED	3	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group 1: HTX-011 HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo Saline placebo by instillation.	Treatment Group 3: Bupivacaine HCI Bupivacaine HCl without epinephrine, 50 mg by injection.
Overall Study Adverse Event	1	0	0
Overall Study Lost to Follow-up	1	1	1
Overall Study Withdrawal by Subject	1	0	1
Overall Study Death	0	0	1

Baseline Characteristics

Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group 1: HTX-011 n=157 Participants HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=100 Participants Saline placebo by instillation.	Treatment Group 3: Bupivacaine HCI n=155 Participants Bupivacaine HCl without epinephrine, 50 mg by injection.	Total n=412 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	133 Participants n=5 Participants	92 Participants n=7 Participants	139 Participants n=5 Participants	364 Participants n=4 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants	48 Participants n=4 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 14.47 • n=5 Participants	47.3 years STANDARD_DEVIATION 12.83 • n=7 Participants	45.5 years STANDARD_DEVIATION 14.79 • n=5 Participants	46.9 years STANDARD_DEVIATION 14.22 • n=4 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	86 Participants n=7 Participants	132 Participants n=5 Participants	356 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants	32 Participants n=7 Participants	49 Participants n=5 Participants	128 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=5 Participants	68 Participants n=7 Participants	106 Participants n=5 Participants	284 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) White	123 Participants n=5 Participants	86 Participants n=7 Participants	128 Participants n=5 Participants	337 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	157 participants n=5 Participants	100 participants n=7 Participants	155 participants n=5 Participants	412 participants n=4 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: ITT Population

Outcome measures

Outcome measures
Measure	Treatment Group 1: HTX-011 n=157 Participants HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=100 Participants Saline placebo by instillation.
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.	323.29 pain intensity score*hr Standard Deviation 182.641	445.34 pain intensity score*hr Standard Deviation 155.792

SECONDARY outcome

Timeframe: 72 hours

Population: ITT Population

Outcome measures

Outcome measures
Measure	Treatment Group 1: HTX-011 n=157 Participants HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=155 Participants Saline placebo by instillation.
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl.	323.29 pain intensity score*hr Standard Deviation 182.641	393.45 pain intensity score*hr Standard Deviation 153.756

SECONDARY outcome

Timeframe: 72 hours

Population: ITT Population

Outcome measures

Outcome measures
Measure	Treatment Group 1: HTX-011 n=157 Participants HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=100 Participants Saline placebo by instillation.
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.	18.80 IV milligram morphine equivalent (MME) Standard Deviation 19.801	30.06 IV milligram morphine equivalent (MME) Standard Deviation 21.016

SECONDARY outcome

Timeframe: 72 hours

Population: ITT Population

Outcome measures

Outcome measures
Measure	Treatment Group 1: HTX-011 n=157 Participants HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=155 Participants Saline placebo by instillation.
Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.	45 Participants	17 Participants

SECONDARY outcome

Timeframe: 72 hours

Population: ITT Population

Outcome measures

Outcome measures
Measure	Treatment Group 1: HTX-011 n=157 Participants HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=155 Participants Saline placebo by instillation.
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.	18.80 IV milligram morphine equivalent (MME) Standard Deviation 19.801	25.09 IV milligram morphine equivalent (MME) Standard Deviation 21.553

Adverse Events

Treatment Group 1: HTX-011

Serious events: 3 serious events

Other events: 111 other events

Deaths: 0 deaths

Treatment Group 2: Saline Placebo

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Treatment Group 3: Bupivacaine HCl

Serious events: 3 serious events

Other events: 112 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group 1: HTX-011 n=157 participants at risk HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=101 participants at risk Saline placebo by instillation. 1 subject was randomized to bupivacaine HCl, but received saline placebo. (Ie, ITT = 100 and Safety population = 101).	Treatment Group 3: Bupivacaine HCl n=154 participants at risk Bupivacaine HCl without epinephrine, 50 mg by injection.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.64% 1/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Hepatobiliary disorders Bile duct stone	0.64% 1/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Intestinal perforation	0.64% 1/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Vascular disorders Venous thrombosis	0.64% 1/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Vascular disorders Deep vein thrombosis postoperative	0.00% 0/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.99% 1/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.65% 1/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.65% 1/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Cardiac disorders Atrial fibrillation	0.00% 0/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.65% 1/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
General disorders Death	0.00% 0/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.65% 1/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.

Other adverse events

Additional Information

Vice President, Clinical Operations

Heron Therapeutics, Inc.

Phone: 855-251-7232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Group 1: HTX-011 n=157 participants at risk HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation.	Treatment Group 2: Saline Placebo n=101 participants at risk Saline placebo by instillation. 1 subject was randomized to bupivacaine HCl, but received saline placebo. (Ie, ITT = 100 and Safety population = 101).	Treatment Group 3: Bupivacaine HCl n=154 participants at risk Bupivacaine HCl without epinephrine, 50 mg by injection.
Gastrointestinal disorders Nausea	37.6% 59/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	43.6% 44/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	45.5% 70/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Nervous system disorders Dizziness	21.7% 34/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	17.8% 18/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	23.4% 36/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Injury, poisoning and procedural complications Incision site oedema	17.2% 27/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	12.9% 13/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	14.3% 22/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Vomiting	14.6% 23/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	18.8% 19/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	21.4% 33/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Nervous system disorders Headache	14.0% 22/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	9.9% 10/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	13.0% 20/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Injury, poisoning and procedural complications Incision site erythema	12.7% 20/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	7.9% 8/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	11.7% 18/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Injury, poisoning and procedural complications Post procedural contusion	12.1% 19/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	12.9% 13/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	11.7% 18/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Cardiac disorders Bradycardia	7.6% 12/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.9% 6/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	7.8% 12/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
General disorders Impaired healing	6.4% 10/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.99% 1/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	3.9% 6/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Constipation	5.7% 9/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	6.9% 7/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	11.7% 18/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Musculoskeletal and connective tissue disorders Muscle twitching	5.7% 9/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.0% 5/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.2% 8/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Skin and subcutaneous tissue disorders Pruritus	5.1% 8/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.9% 6/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	0.65% 1/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Cardiac disorders Sinus arrhythmia	3.8% 6/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.9% 6/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	6.5% 10/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Nervous system disorders Dysgeusia	2.5% 4/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.9% 6/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	3.9% 6/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Skin and subcutaneous tissue disorders Pruritus generalised	2.5% 4/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	4.0% 4/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.2% 8/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.
Ear and labyrinth disorders Tinnitus	1.3% 2/157 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	2.0% 2/101 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.	5.2% 8/154 • 42 days. For each Preferred Term (PT), subjects are included only once, even if they experienced multiple events in that PT.