It is reported that on July 30th, Vertex announced that the FDA has accepted the marketing application for the Nav1.8 inhibitor VX-548 (Suzetragine) and granted priority review eligibility for the treatment of moderate to severe acute pain. The PDUFA date is January 30th, 2025.

 

 

 

Suzetrigine is an oral selective NaV1.8 pain signal inhibitor used to treat moderate to severe acute pain, and it has the potential to become a new mechanism drug for the treatment of acute pain for over 20 years.

 

 

 

The data shows that compared with other NaV ion channels, this drug has a high selectivity for NaV1.8. NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signal transduction in the peripheral nervous system. It is a pain treatment target that has been genetically validated. Vertex's strategy is to develop new drug types by selectively inhibiting NaV1.8. Compared to opioid drugs, they may provide better analgesic effects while avoiding side effects such as addiction.

 

 

 

It is reported that at the end of January this year, Vertex released phase III clinical data on VX-548 treatment for moderate to severe acute pain. The main clinical endpoint indicators of this clinical trial are the Time Weighted Sum Score of Pain Intensity Differences within 48 Hours (SPID48) and the Digital Pain Rating Scale (NPRS), where the score represents the decrease in pain intensity. This experiment includes two parts of analgesic treatment: abdominal plastic surgery and hallux valgus correction surgery, which are not only compared with placebo, but also with opioid analgesics.

 

 

 

Overall, VX-548 has shown significant therapeutic effects in phase III clinical trials. Although it has not demonstrated analgesic efficacy superior to opioid analgesics, it represents a qualitative leap in acute analgesics in terms of non addictive properties. The industry has stated that the success of VX-548 as a non opioid acute pain medication over the past two decades is of significant importance. At the same time, it also marks Vertex's successful expansion into the field of common diseases after years of layout.

 

 

 

According to Vertex's statement, it plans to request FDA approval for VX-548 in the second half of 2024 for the treatment of moderate to severe acute pain. It is reported that there is still greater room for expanding the indications of its subsequent pipelines. The indications of VX-548 for diabetes peripheral neuropathy obtained positive clinical data in phase II in December 2023, reaching the main end point, while the clinical manifestations of lumbosacral radiculopathy are also in phase II.

 

 

 

The vast indication space will give this drug enormous sales potential. Some predict that VX-548 will generate $4.4 billion in sales for acute pain indications by 2032; It will generate $7 billion in sales for neuropathic pain indications.

 

 

 

According to the data, Vertex is engaged in the business of discovering, developing, producing, and commercializing small molecule drugs for patients with serious illnesses. It is committed to developing and commercializing therapies for the treatment of cystic fibrosis, infectious diseases (including viral infections such as influenza and bacterial infections), autoimmune diseases (such as rheumatoid arthritis, cancer, inflammatory bowel disease), and neurological diseases (including pain and multiple sclerosis). It is reported that Vertex's fame mainly stems from its years of deep cultivation in the field of cystic fibrosis (CF).