Vanda edges toward key tradipitant decision as FDA extends review

US biotech Vanda Pharmaceuticals (Nasdaq: VNDA) says the US Food and Drug Administration (FDA) has extended its expedited re-review of a partial clinical hold on long-term studies of tradipitant for motion sickness. The deadline moves to December 5 after leadership changes at the review division, with all other elements of the framework unchanged.

The company’s New Drug Application for tradipitant, filed to prevent vomiting caused by motion, remains on track with a December 30 action date. The regulator has now provided labeling comments, formally opening negotiation with Vanda as it aims to deliver the first new pharmacologic option for motion sickness in more than 40 years.

Motion sickness affects a wide spectrum of travellers, sailors and passengers, with some studies estimating vulnerability as high as 60% in challenging conditions. Despite the burden, treatment has relied on older generics such as scopolamine patches and dimenhydrinate tablets, both inexpensive but often limited by sedation and other side-effects.