XenoPort of Santa Clara and its partner said Monday they withdrew their new drug application for Solzira, its time-released treatment of moderate-to-severe restless drug syndrome after the Food and Drub Administration asked for modifications to a study.
The news sent shares of XenoPort down $5.12, or 13 percent, to $34.44, although during the day they slumped even further, touching a 52-week low of $30.10 at one point.
The FDA specifically requested that the data in a single study be “reformatted”. The company’s partner in the drug study, GlaxoSmithKline, also said it will conduct a review of other “trial data set taking this input into account.”
Xenoport said that the withdrawal doesn’t relate “to the content” of new drug application and that GlaxoSmithKline intends to resubmit the application “quickly” once its work is complete.
In the meantime, Xenoport won’t receive a $23 million milestone payment associated with acceptance of the application by the FDA.