FDA accepts Vertex non-opioid pain med NDA
2024-04-19
临床2期申请上市临床3期突破性疗法
Vertex Pharmaceuticals has announced several regulatory milestones for suzetrigine, a non-opioid pain medication with the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades.
The FDA has accepted a rolling submission for a New Drug Application (NDA) for suzetrigine for moderate-to-severe acute pain, with the first module submitted and completion expected within the current quarter.
For neuropathic pain, specifically pain associated with diabetic peripheral neuropathy (DPN), Vertex has also successfully completed an end-of-phase 2 meeting with the FDA. Following positive phase 2 results, the company is preparing to launch a phase 3 study in the latter half of 2024. Suzetrigine has also received the FDA’s Breakthrough Therapy designation for its application in DPN treatment.
In addition to these developments, Vertex continues its phase 2 trial of suzetrigine for lumbosacral radiculopathy, with enrollment projected to conclude by year-end.
Suzetrigine is an oral selective NaV1.8 pain signal inhibitorNaV1.8 pain signal inhibitor that targets the NaV1.8 sodium channel, crucial for transmitting pain signals in the peripheral nervous system. By inhibiting this channel, suzetrigine aims to reduce pain without affecting other sodium channels involved in different bodily functions.
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