A Rockville biotech has turned over the fate of its attention deficit hyperactivity disorder drug to regulators.
Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) said it has resubmitted its application for an ADHD treatment for pediatric patients to the Food and Drug Administration after the agency rejected its application in November. The company met with regulators in January — when it had initially hoped to launch the product — and now awaits its review. That could take either two months or six months, depending on how the FDA classifies the application.
When the agency turned down the company’s new drug application to market the treatment to children and adolescents ages 6 to 17, it wasn’t the only time Supernus received such a response. The FDA had also refused to accept the company’s application for SPN-830, its apomorphine infusion pump for the continuous treatment of “on-off” episodes in Parkinson’s disease. Supernus had inherited that asset in its April acquisition of Louisville, Kentucky-based biopharma US WorldMeds.
The company said in November it would seek guidance from the FDA and refile its application, but it has not reported having done so yet.
But Supernus, which focuses on central nervous system diseases, closed 2020 with some good news. In December, it reported positive results from a clinical trial of the same candidate, SPN-812, which was found to improve ADHD symptoms in adults, as well as to be safe and generally well-tolerated. The company said Monday it plans to submit a supplemental new drug application to the FDA based on this data in the second half of this year — if the agency approves the treatment for pediatric patients.
That study reinforced positive data from a prior trial, after mixed results back in 2019.
The candidate’s active ingredient, viloxazine hydrochloride, was marketed for years in Europe as an antidepressant. But the ADHD marketplace is a competitive one, with players such as Strattera from Eli Lilly & Co. (NYSE: LLY) that’s also now available in a cheaper generic version.
Still, the product is different, Supernus President and CEO Jack Khattar has said, because it starts working sooner and patients adjust faster than with other products. It’s designed to treat multiple symptoms of ADHD, a condition characterized by hyperactivity and difficulty paying attention.
Supernus had a strong 2020, with product sales performance “better than we originally expected in this uncertain environment,” Khattar said in reference to the coronavirus pandemic on a third-quarter earnings call. The company closed the third quarter with $152.1 million in net product sales, 52% higher than the same period in 2019. That was fueled by an additional $40.9 million from commercial products it acquired from US WorldMeds and another $11.2 million in revenue growth from epilepsy drugs Trokendi XR and Oxtellar XR. Supernus had $252.4 million in working capital at the end of September.
Though an FDA green light wouldn’t be the biopharma’s first, it would follow other notable, recent approvals in the region. Maryland’s MacroGenics Inc. (NASDAQ: MGNX) and Viela Bio Inc. (NASDAQ: VIE) both earned approvals to commercialize their first products in 2020, and D.C.’s Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) got the OK to start selling its existing drug, Hetlioz, to treat nighttime sleep disturbances in Smith-Magenis Syndrome.
That’s on top of a flurry of activity in Montgomery County, including Seraxis Inc.’s $40 million round, Vigene Biosciences Inc.’s footprint expansion, Novavax Inc.’s rolling regulatory review for its experimental Covid-19 vaccine, Sensei Biotherapeutics Inc.'s (NASDAQ: SNSE) $133 million IPO and Viela’s planned $3.1 billion sale to Dublin’s Horizon Therapeutics (NASDAQ: HZNP).
Supernus's stock price closed up 1.56% Tuesday at $31.19 per share.
