Supernus touts winning data in adult ADHD as it looks to make its case with the FDA — again — for pediatric use
Less than two months after being rejected by the FDA for pediatric patients, Supernus Pharmaceuticals’ ADHD program has new data in an older population that the company hopes will reverse its fortunes. Will the agency bite?
Supernus’ $SUPN SPN-812 improved adult patients’ results on an important ADHD symptoms test at a statistically significant rate higher than placebo, according to topline Phase III results posted Tuesday evening. The biotech had sought approval in children ages 6 to 17, but was shot down in November after regulators cited concerns about an in-house lab used to analyze the experimental drug.
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