The FDA is expected to make a decision on Vertex’s non-opioid medicine for acute pain by Jan. 30, the company announced on Tuesday.
The experimental drug, suzetrigine, showed in two Phase 3 trials released in January that it can treat pain in certain settings without the risk of addiction. If approved, it would be the first new drug class for acute pain in more than two decades.
Suzetrigine would also have to compete against cheap and widely available opioids. About 12.7 million adults under 64 years old filled at least one opioid prescription from 2020 to 2021, according to the HHS’ Agency for Healthcare Research and Quality.
The agency has granted suzetrigine priority review, shortening its assessment from 10 months to six. Vertex began a rolling submission earlier this year, and told Endpoints News on Tuesday that the FDA has not indicated plans to hold an advisory committee meeting.
“The filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential,” chief regulatory and quality officer Nia Tatsis said in a news release.