The US Food and Drug Administration (FDA) has accepted Vertex Pharmaceuticals’ completed new drug application (NDA) submission for suzetrigine, as the company’s non-opioid-based treatment for acute pain inches closer to market.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 30 January 2025, according to a 30 July press release.
Shares in the US company, which has a market cap of $129.7bn, opened 0.9% higher on 31 July.
Formerly known as VX-548, suzetrigine has fast track and breakthrough therapy designations for its use as a treatment for moderate to severe acute pain, meaning the drug has an expedited review process. The agency previously granted a rolling NDA submission to Vertex in April this year.
Suzetrigine is a voltage-gated sodium channel inhibitor, specifically targeting NaV1.8. This channel is expressed in peripheral pain-sensing neurons, known as nociceptors, and plays a role in propagating pain signals.
Vertex states it aims to create a “new class of pain signal inhibitors”, that go beyond the limitations of current therapies – one of which is the addictive nature of opioids. The over-prescription of opioid pain medication such as oxycontin, along with the widespread availability of synthetic opioids such as fentanyl, has led to epidemics around the world. Opioid overdoses are the leading cause of accidental deaths in the US.
Suzetrigine demonstrated positive results in two randomised Phase III trials in patients with moderate-to-severe acute pain. The drug led to significant improvements in pain intensity in the 48 hours after patients underwent abdominoplasty (NCT05558410), commonly known as tummy tucks, and bunionectomies (NCT05553366), meaning the studies met their primary endpoints. The pair of trials enrolled 2,193 surgical patients in total.
However, the drug’s clinical journey was not without a setback. In the same studies, suzetrigine failed to show higher effectiveness compared to the painkiller Vicodin (hydrocodone/acetaminophen), causing the trials to miss their secondary endpoints. Vicodin, manufactured by Abbott, is relatively cheap and widely accessible but is opioid-based.
The global pain management market, which includes acute pain, is projected to reach approximately $115bn by 2032, according to GlobalData’s AI hub.
GlobalData is the parent company of Pharmaceutical Technology.
Suzetrigine is estimated to reach blockbuster status by 2029 and achieve $1.4bn in sales by 2030, according to an analysis by GlobalData’s Pharma Intelligence Centre.
Vertex’s executive vice-president, chief regulatory and quality officer Nia Tatsis said: “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 added that the filing brings Vertex one step closer to “filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential”.
