FDA to Review Vertex’s Potential Blockbuster Painkiller Suzetrigine Next Year

The US Food and Drug Administration (FDA) has officially accepted Vertex Pharmaceuticals' new drug application (NDA) for suzetrigine, a non-opioid treatment for acute pain. This acceptance marks a significant step toward making the drug available to the public. The FDA has set the Prescription Drug User Fee Act (PDUFA) target action date for 30 January 2025, according to a press release issued on 30 July. Following this announcement, shares in Vertex Pharmaceuticals, a company with a market capitalization of $129.7 billion, saw a slight increase of 0.9% on 31 July.

Suzetrigine, previously known as VX-548, has been granted fast track and breakthrough therapy designations by the FDA for its role in treating moderate to severe acute pain. These designations are meant to expedite the review process of the drug. Earlier this year, in April, the FDA had also granted Vertex a rolling NDA submission for suzetrigine.

Suzetrigine is designed to be a voltage-gated sodium channel inhibitor, specifically targeting the NaV1.8 channel. This channel is found in peripheral pain-sensing neurons called nociceptors and is crucial in transmitting pain signals. Vertex aims to create a "new class of pain signal inhibitors" that circumvent the limitations of current treatments, especially the addictive nature of opioids. Over-prescription of opioid pain medications like oxycontin and the widespread availability of synthetic opioids such as fentanyl have led to opioid epidemics globally, with opioid overdoses being the leading cause of accidental deaths in the United States.

Suzetrigine has shown promising results in two randomized Phase III clinical trials involving patients with moderate-to-severe acute pain. The drug significantly improved pain intensity within 48 hours post-abdominoplasty (commonly known as tummy tucks) and bunionectomies, thereby meeting the primary endpoints of these studies. In total, the pair of trials enrolled 2,193 surgical patients.

However, the clinical path for suzetrigine had its challenges. In these same studies, the drug did not demonstrate higher effectiveness compared to the painkiller Vicodin (a combination of hydrocodone and acetaminophen). This failure caused the trials to miss their secondary endpoints. Vicodin, produced by Abbott, is both cost-effective and readily available but is opioid-based.

The global market for pain management, including acute pain, is forecasted to reach around $115 billion by 2032, according to GlobalData’s AI hub. Suzetrigine itself is projected to reach blockbuster status by 2029, with expected sales of $1.4 billion by 2030, based on analysis from GlobalData’s Pharma Intelligence Centre.

Nia Tatsis, Vertex’s executive vice-president, chief regulatory and quality officer, stated, “Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients suffering from moderate-to-severe acute pain each year in the US.” Tatsis further elaborated that this filing moves Vertex closer to addressing the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.

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