Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

Introduction

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.

FDA Approval of JOURNAVX™

JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years.

A Historic Milestone

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “With the approval of JOURNAVX, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

Medical Perspective on JOURNAVX™

Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine in San Diego, stated, “I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.”

Understanding Acute Pain

Acute pain is a serious and potentially disabling condition often caused by surgery, accident, or injury. Over 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year.

About JOURNAVX™ (suzetrigine)

JOURNAVX (suzetrigine) is a first-in-class, oral, non-opioid, highly selective pain signal inhibitor that is selective for NaV1.8. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons, where its role is to transmit pain signals.

Safety and Usage Information

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain. It is not known if JOURNAVX is safe and effective in children. Patients should not take JOURNAVX if they take certain medicines that are strong inhibitors of an enzyme called CYP3A.

Possible Side Effects

The most common side effects include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Patients should consult their healthcare provider if they experience any concerning symptoms.