A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries

Purpose

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.

Condition

  • Acute Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m^2) - Scheduled to undergo a procedure that is in one of the following categories that would typically be treated with opioid therapy for at least 72 hours postoperatively such as - Laparoscopic intraperitoneal or retroperitoneal procedure - Arthroscopic orthopedic procedure

Exclusion Criteria

  • Participated in previous study with Suzetrigine or received Journavx Other protocol defined Inclusion/Exclusion criteria will apply.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Suzetrigine (SUZ)
Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.
  • Drug: Suzetrigine
    Tablets for oral administration.
    Other names:
    • VX-548
    • SUZ
    • Journavx

Recruiting Locations

Memorial Hermann Village
Houston, Texas 77043

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com