(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) announced on Thursday that the U.S. FDA has lifted the partial clinical hold on its motion sickness protocol, VP-VLY-686-3403, for Tradipitant, which had previously limited the protocol to a maximum of 90 doses.
Tradipitant is a neurokinin-1 (NK-1) receptor antagonist licensed by Vanda from Eli Lilly. It is currently in development for multiple indications, including gastroparesis, motion sickness, and nausea/vomiting induced by GLP-1 receptor agonists.
The U.S. regulatory agency imposed a partial clinical hold (PCH) on two proposed Tradipitant studies in December 2018, requiring Vanda to complete additional chronic toxicity studies in canines, monkeys, or minipigs before allowing patient enrollment in any clinical protocol lasting longer than 12 weeks.
Now, with the FDA agreeing with Vanda's position that motion sickness is an acute, self-limiting physiologic response rather than a chronic or chronic-intermittent condition, the requirement for an additional six-month dog toxicity study has been removed, making the partial clinical hold no longer necessary.
Separately, the FDA continues to review Vanda's fully completed NDA for tradipitant in the prevention of motion sickness. The PDUFA target action date is December 30, 2025, positioning tradipitant as potentially the first new pharmacological treatment for motion sickness in over four decades.
"The swift and favourable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals.
VNDA closed yesterday's trading at $5.20, down 1.33%, but rose to $5.50, up 5.77% in the overnight trading session. Over the past 12 months the stock has traded between $3.81 and $5.70.
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