Vanda reports Phase III trial shows NEREUS cuts GLP‑1‑induced vomiting
Vanda Pharmaceuticals announced that its Phase III Study 3601 of NEREUS™ (tradipitant) met its primary and key secondary endpoints for preventing vomiting in patients receiving GLP‑1 receptor agonists. The drug lowered the incidence of any vomiting from 58.5% on placebo to 43.0% and reduced combined vomiting‑plus‑severe nausea from 50.6% to 33.1%. Vanda said it will discuss the data with the FDA and intends to file a supplemental New Drug Application for this new indication.
Why it matters
If the FDA accepts the supplemental NDA, NEREUS could be added to the $50 billion GLP‑1 market, giving Vanda a new revenue stream. The company indicated it will pursue regulatory discussion based on the trial data.
Key facts
- 1The trial enrolled 306 participants, with 142 receiving NEREUS and 164 receiving placebo. investing.com
- 2Any vomiting occurred in 43.0% of NEREUS‑treated patients versus 58.5% on placebo, a 27% relative reduction (p=0.006). prnewswire.com
- 3Vomiting combined with severe nausea was observed in 33.1% of NEREUS patients compared with 50.6% on placebo, a 35% relative reduction (p=0.002). investing.com
- 4Frequent multi‑day vomiting (>2 episodes on more than one day) was reported in 6.3% of NEREUS participants versus 15.9% on placebo, a 60% relative reduction (p=0.008). prnewswire.com
- 5Extreme vomiting (>10 total episodes) occurred in 2.8% of the NEREUS group versus 14.6% of placebo, an 81% relative reduction (p=0.0003). investing.com
- 6Vanda plans to discuss the results with the FDA and submit a supplemental New Drug Application for the GLP‑1‑induced vomiting indication. prnewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.