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MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.
The company announced the start of a phase-3 trial of USL261 (midazolam), a drug administered via the nose to stop seizures in patients on stable anti-epileptic drug regimens who have intermittent bouts of increased seizure activity, also known as seizure clusters, which affect about 152,000 Americans. The Food and Drug Administration has granted the medication orphan-drug designation, which the agency gives to drugs for treating conditions that affect fewer than 200,000 people in the United States.
The trial, “ARTEMIS1,” will compare the drug with placebo in patients ages 14 to 65 years.