Supernus' nonstimulant ADHD drug Qelbree gains approval for adult use
Up to 90% of the children that are diagnosed with attention deficit hyperactivity disorder retain the diagnosis into adulthood. Now, those adults will have another nonstimulant option for treatment, as the FDA approved an expanded indication for the use of Supernus Pharmaceuticals’ product in adults.
The drug, Qelbree, is now approved for everyone above the age of 6 diagnosed with ADHD. There are roughly 16 million people in the US with the disorder.
Qelbree is taken once daily, and showed no evidence of abuse in clinical studies. The nonstimulant is the first approval of its kind in 20 years. The daily flexible dose is between 200 mg and 600 mg, and showed significant improvement in the adult ADHD Investigator Symptom Rating Scale (AISRS) score, with a p-value of 0.0040.
“As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD,” Supernus CEO Jack Khattar said in a statement. “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients. We are proud to bring a new novel nonstimulant option for adults into the market after two decades.”
Qelbree was first approved for the use in children between the age of 6 and 17 around this time last year. Regulators first rejected the application in November 2020, due to CMC issues after the relocation of an in-house lab that raised questions about quality control.
It was a long journey to approval for the Supernus team. Back in 2018, the Phase III data fell flat, after Qelbree failed to show a dose-dependent response. Investors worried that it would be difficult to differentiate the drug from Eli Lilly’s Strattera and Shire’s Intuniv.
“Until today, nonstimulant ADHD options for adults have been very limited,” Greg Mattingly, co-founder of St. Charles Psychiatric Associates, said in a statement. “This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms.”
The approval for children did come with a warning, though, and the adult approval mirrored it.
Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. Qelbree should not be taken by patients that also take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines.
Back in 2020, Supernus forked over $300 million to grab the CNS portfolio of US WorldMeds. With that, it picked up Apokyn, Myobloc and Xadago. In addition to ADHD, the biopharma has drugs for epilepsy, migraines and Parkinson’s disease in its portfolio.