Sciele says drooling treatment succeeds in trial

Sciele Pharma Inc. said Tuesday it successfully completed a late-stage clinical trial of glycopyrrolate, a drug candidate designed to treat drooling in children with cerebral palsy and other neurological disorders.

The 24-week trial compared liquid glycopyrrolate to a placebo, and Sciele said patients who took the drug drooled significantly less after eight weeks. The drug is intended to treat chronic moderate to severe drooling in children 3 to 18 with cerebral palsy, mental retardation, or any other neurological condition associated with drooling.

The trial was part of the company's New Drug Application to the Food and Drug Administration. Sciele plans to submit its complete NDA during the fourth quarter of 2008.

In the trial, drooling was measured by parents and caregivers based on the modified Teacher's Drooling Scale.

Glycopyrrolate received orphan drug status from the FDA in 2006. Orphan drugs are designed to treat rare diseases, and they can be awarded market exclusivity for up to seven years if they are approved for sale.

In morning trading, Sciele shares declined 6 cents to $30.37.