Supernus says ADHD drug trounces rivals, but shares slide

Supernus Pharma has two phase III trials showing its attention-deficit hyperactivity disorder (ADHD) drug SPN-812 met its objectives, but still saw its shares fall as investors digested the data. The US biotech has been positioning the non-stimulant drug as a safer, more tolerable alternative to already-marketed non-stimulants for ADHD such as Eli Lilly’s Strattera (atomoxetine) and Shire’s Intuniv (guanfacine), both of which have cheap generic variants available in the US.
It is testing the drug in four placebo-controlled phase III trials, including two in children aged six to 11 that have just generated results, as well as two in adolescents aged 12 to 17, one of which will read out later this month and the other in early 2019. The two trials in younger patients show that SPN-812 – also known as viloxazine hydrochloride – both showed that the drug performed significantly better than placebo on hyperactivity, impulsivity and inattention scales, sufficient for Supernus to say it will press ahead with plans for a regulatory filing with the FDA in the second half of 2019.
Despite the company’s upbeat assessment – perfectly reasonable since the drug hit all its objectives in the two studies – shares nevertheless fell more than 13% after the data were announced. The problem is that questions are being asked as to whether SPN-812 is sufficiently better than a generic non-stimulant drug to justify a brand name price.