Supernus battles back from CRL, scoring the FDA's approval for non-stimulant ADHD med Qelbree
After a harsh slapdown last fall, US regulators are now singing a different tune on Supernus Pharmaceuticals’ “sprinkleable” ADHD drug.
The FDA on Friday approved SPN-812 — now marketed as Qelbree — as a non-stimulant treatment for ADHD in kids 6 to 17 years old. And with new data in hand for adult patients, the company plans on filing a supplemental NDA in the second half of this year.
Regulators initially rejected Supernus’ application for Qelbree back in November at the same time they issued an RTF for SPN-830, a continuous treatment pump meant for Parkinson’s disease.
Supernus said Qelbree’s rejection had to do with CMC issues after the relocation of an in-house lab that does analytic testing raised questions in the agency about quality control. At the time, the Rockville, MD-based biotech said it would clarify to the FDA that it doesn’t rely solely on that facility for quality control and resubmit.
The Friday approval sent Supernus’ stock $SUPN up 8.12% in pre-market trading, with shares pricing at $28.89 early Monday morning.
Supernus bills Qelbree as the first new non-stimulant treatment for ADHD in a decade. The agency based its decision on data from four Phase III trials that enrolled more than 1,000 pediatric patients between 6 and 17 years old, according to the company.
An early cut of Phase III data fell short of expectations back in 2018, after Qelbree failed to show a dose-dependent response in the high dose. Some investors worried that the drug may have not performed well enough to differentiate itself from existing ADHD drugs such as Eli Lilly’s Strattera and Shire’s Intuniv.
Supernus, however, pointed to Qelbree’s swift onset of action. Strattera, the first non-stimulant medication approved for ADHD, can take more than six weeks to start working, while some patients felt the effects of Qelbree in just one. Strattera reached $535 million in the US before going generic, according to Cowen’s Ken Cacciatore.
“ADHD is one of the most common mental health issues in the US,” said Andrew Cutler, SUNY Upstate Medical University associate professor and Neuroscience Education Institute CMO. “The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.”
In December, Supernus read out topline Phase III data showing that Qelbree significantly improved adult patients’ results on the ADHD Investigator Symptom Rating Scale (AISRS) compared to placebo. At the end of six weeks, those in the Qelbree group saw a change of -15.5 from baseline in AISRS scores compared to -11.7 in the control arm, with a p-value of 0.0040, according to Supernus. The statistical significance was confirmed later by a sensitivity analysis showing a p-value of 0.0085.
Qelbree’s approval in children 6 to 17 years old came with a warning: “In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with Qelbree than in patients treated with placebo,” the label states. “Closely monitor for worsening and emergence of suicidal thoughts and behaviors.”