Supernus (SUPN) Receives FDA Approval for ADHD Treatment

 | Apr 05, 2021 01:16AM ET

Supernus Pharmaceuticals (NASDAQ:SUPN), Inc. SUPN announced that the FDA approved its pipeline candidate, SPN-812, (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The candidate was approved under the brand name, Qelbree.

The approval was supported by data from an extensive development program consisting of four phase III clinical studies, which evaluated more than 1000 pediatric patients aged 6 to 17 years.

We remind investors that the FDA accepted for review the NDA for SPN-812 for the treatment of ADHD in the above-mentioned patient population in January 2020 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Nov 8, 2020.

However, in November 2020, the regulatory body issued a Complete Response Letter (CRL) for the NDA. The CRL indicated that the review cycle for the NDA was complete but was not ready for approval in its present form. The primary issue cited in the CRL was related to the company’s in-house laboratory that conducts analytical testing, which recently moved to a new location.

Thereafter, in January 2021, Supernus met with the FDA in a Type A meeting to discuss the CRL and the requirements for the NDA resubmission. In February 2021, the company resubmitted the SPN-812 NDA and removed the reference to its in-house laboratory, and addressed other contents of the CRL.

The approval strengthens Supernus’ portfolio for the treatment of central nervous system (CNS) diseases, which include epilepsy treatments (Trokendi XR and Oxtellar XR) and Parkinson’s Disease treatment (Apokyn).

Meanwhile, in December 2020, Supernus announced positive results from a phase III study in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

Shares of Supernus have gained 14.5% so far this year compared with the industry ’s increase of 5.2%.