The FDA will have six months to review Vertex Pharmaceuticals’ suzetrigine, potentially the first new class of drugs for acute pain in more than 20 years, according to the company.
Vertex Pharmaceuticals on Tuesday announced that the FDA has accepted the New Drug Application for suzetrigine, an investigational oral non-opioid treatment for moderate to severe acute pain. The regulator’s decision is due on Jan. 30, 2025.
If approved, suzetrigine could potentially be the first new class of drug approve for acute pain in more than 20 years, according to Vertex. The FDA granted suzetrigine Priority Review, which shortens the regulatory review period down to six months. Suzetrigine previously secured the regulator’s Fast Track and Breakthrough Therapy designations.
Nia Tatsis, chief regulatory and quality officer at Vertex, in a statement called the FDA’s acceptance of suzetrigine’s application “a critical milestone” for the “millions of patients suffering from moderate-to-severe acute pain each year in the U.S.” Suzetrigine is a “transformative non-opioid analgesic” that provides effective pain relief to patients without to known risks and addictive potential of opioids, Tatsis said.
Designed to be orally administered, suzetrigine is an investigational pain signal inhibitor that selectively binds to the NaV1.8 voltage-gated sodium channel, which is typically found on peripheral pain-sensing neurons and transmit pain signals back to the central nervous system. According to Vertex, NaV1.8 is a genetically validated pain target.
The pharma is backing suzetrigine with data from three Phase III trials and two Phase II studies, which together established a favorable risk/benefit profile for the drug candidate. In January 2024, the company released Phase III data for suzetrigine, touting significant pain relief in both surgical and non-surgical settings.
Within 48 hours after a tummy tuck, also called abdominoplasty, suzetrigine significantly eased patients’ pain intensity compared with placebo. Patients who had undergone a corrective procedure to remove a bone deformity in the toes, known as a bunionectomy, also experienced a significant reduction in pain 48 hours after suzetrigine treatment.
In a separate late-stage study, 83.2% of patients responded in a survey, agreeing that suzetrigine was good, very good or excellent at easing pain. These patients had undergone various surgical or non-surgical operations.
In April 2024, Vertex kicked off its rolling submission for suzetrigine in moderate-to-severe acute pain.
Vertex has also demonstrated the potential of suzetrigine in diabetic peripheral neuropathy (DPN), a type of chronic pain, through a Phase II study. The company is currently preparing to launch a Phase III study in this indication, which is set to begin in the second half of this year. Suzetrigine also has the FDA’s Breakthrough Designation for DPN.
