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.
The news brought some early Christmas joy to investors, as shares jumped roughly 16% in early Wednesday trading.
Supernus is plotting to submit the adult data to the FDA as a possible supplement to its sought-after approval in pediatric patients — but that would require a positive result from the pharma’s meeting with the agency in January to discuss that CRL from last month. If a turnaround approval does come early next year, Supernus said it would likely petition for an adult OK in the second half of 2021.
Researchers tested SPN-812 in 374 adults in a randomized, double-blinded and placebo-controlled setting. Patients in the drug arm took the once-daily pill for six weeks, starting with a 200-mg dose but with the option to increase dosage up to 600 mg. To measure efficacy, Supernus looked at the change from baseline to the end of the study on the ADHD Investigator Symptom Rating Scale, or AISRS.
At the end of six weeks, those in the SPN-812 group saw a change of -15.5 in AISRS scores compared to -11.7 in the control arm. Those figures turned out a p-value of p=0.0040, and Supernus said the statistical significance was confirmed later by a sensitivity analysis showing a p-value of p=0.0085.
The company also put forth data it said showed the program indicated a fast onset of action, reaching statistical significance after just two weeks. Though Supernus did not provide change from baseline figures, they said the p-value following this period was p=0.0397.
Supernus didn’t clarify how it planned to answer the FDA’s concerns outlined in the November CRL to push for a pediatric nod. The in-house lab that does analytic testing had recently changed locations prior to the agency’s review, Supernus said, raising questions about quality control. Supernus said at the time they aimed to clarify the lab is not the only facility used to test the candidate.
November’s rejection was a significant blow for Supernus, given the company has conducted four trials in the ADHD field. It also came hand in hand with the agency refusing to even consider an application for Supernus’ SPN-830, a continuous treatment pump meant for Parkinson’s disease.