The drug is being developed to treat chronic, moderate-to-severe drooling in pediatric patients with conditions like cerebral palsy and other neurological disorders that cause the drooling side effect.
First Horizon said it has ongoing clinical trials focused on the new indication, adding that its drug is already approved as an adjunctive therapy for treating peptic ulcers.
The Food and Drug Administration's orphan drug designation is reserved for drugs that treat serious diseases that affect fewer than 200,000 people in the United States. The status includes a waiver of application fees and seven years' market exclusivity for the drug if approved.
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