Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty

Vertex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: Placebo (matched to SUZ); Drug: Suzetrigine (SUZ); Drug: Placebo (matched to HB/APAP); Drug: HB/APAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05558410

VX22-548-105

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.

Enrollment: 1,118 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Before Surgery

  • Participant scheduled to undergo a standard ("full") abdominoplasty procedure

• After Surgery

  • Participant is lucid and able to follow commands and able to swallow oral medications
  • All analgesic guidelines were followed during and after the abdominoplasty
  • Abdominoplasty procedure duration less than or equal to (≤3) hours

Key Exclusion Criteria:

• Before Surgery

  • Prior history of abdominoplasty
  • History of Intra-abdominal and/or pelvic surgery that resulted into complications
  • History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
  • Any prior surgery within 1 month before the first study drug dose

• After Surgery

  • Participant had a non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
  • Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,118 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.

Treatment:

Drug: Placebo (matched to HB/APAP)

Drug: Placebo (matched to SUZ)

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Active Comparator group

Description:

Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.

Treatment:

Drug: HB/APAP

Drug: Placebo (matched to SUZ)

Suzetrigine (SUZ)

Experimental group

Description:

Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 48 hours.

Treatment:

Drug: Placebo (matched to HB/APAP)

Drug: Suzetrigine (SUZ)