dropped more than 30% today after the company said it will delay by six months to a year filing for government approval of its skin patch to treat attention-deficit hyperactivity disorder.
Miami-based Noven said early analysis of the late-stage testing data showed that additional testing is needed before the company submits a drug approval filing with the
U.S. Food and Drug Administration
shares lately were down $11.31, or 39.96%, to $17.
The drug in question, methylphenidate, is already prescribed in an oral form for children with ADHD. Noven believes its skin patch will be easier to use with children, because it won't require an oral dosage during school hours.
"We had planned to file late in the second quarter of 2001. Based on our early analysis and subject to our discussions with the FDA, that filing will be delayed by six to 12 months," said Robert Strauss, Noven's CEO, chairman and president.