Rockville’s Supernus Pharmaceuticals Inc. has come out of a late-stage clinical trial for its attention deficit hyperactivity disorder treatment with positive results, a big win for the company on the heels of a recent blow from regulators for the same candidate.
The company said late Tuesday its study of SPN-812 met its primary endpoint in improving ADHD symptoms in adults. The phase 3 trial also showed strong safety and tolerability in the patients who received it.
“These compelling data in adults will be important for our planned [supplemental new drug application] submission to make this treatment option available, if approved by the Food and Drug Administration, to the adult ADHD patient population, which represents approximately half of the total ADHD market in the U.S.,” Supernus President and CEO Jack Khattar said in a statement.
Supernus (NASDAQ: SUPN) now has data proving the candidates safety and efficacy “in a broad range of ADHD patient populations” including children, adolescents and adults, he said.
The company’s share price jumped more than 20% early afternoon Wednesday to $27.10.
It comes less than two months after the FDA rejected the company’s application to market the treatment to children and adolescents ages 6 to 17. The agency issued a Complete Response Letter in November stating the biotech’s application was “not ready for approval in its present form.”
Supernus plans to meet with the FDA in January to discuss the letter, the company said Tuesday. “Assuming approval for pediatrics,” it said, Supernus expects to submit its application to the FDA for SPN-812 in adults in the second half of 2021.
The latest study reinforces positive data from that previous trial, Supernus said, after earlier mixed results in March 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, 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.
It all follows the FDA’s refusal 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 — which inherited that asset in its April acquisition of Louisville, Kentucky-based biopharma US WorldMeds — said in November it would seek guidance from the FDA and refile its application.
“These two late-stage assets represent two important growth drivers for the company, and we are very focused on driving them towards commercialization and market success,” Khattar said on a Nov. 4 earnings call, before the FDA’s responses.
We have reached out to the company for additional updates and will update this post if we hear back.
Supernus, which focuses on central nervous system diseases, has had a strong 2020. The company closed the third quarter with $152.1 million in net product sales, 52% higher than the same period in 2019, it reported in filings with the Securities and Exchange Commission. The business had $252.4 million in working capital at the end of September.
