FDA hits Supernus with double whammy, handing biotech a CRL and RTF on same day
Supernus had a bad Monday.
Yesterday, the Maryland biotech announced that two different therapies had been shot back by the FDA. The agency rejected their application to approve SPN-812, an experimental ADHD medication for kids and adolescents. And they refused to even consider an application for SPN-830, a continuous treatment pump meant for Parkinson’s disease.
The rejection is a significant blow to Supernus, which invested in four clinical trials for the ADHD med. The FDA doesn’t disclose its reasoning for rejecting a drug, but the company said it had to do with CMC issues, rather than safety or efficacy concerns. An in-house lab that does analytic testing recently changed locations, they said, raising questions in the agency about quality control.
Supernus said they plan to “clarify to the FDA” that they do “not rely solely on this facility” for quality control and then discuss how to resubmit their application.
The company was less forthcoming on why the agency refused to file their Parkinson’s application. “In the letter, the FDA requested certain documents and reports to be submitted in support of the application,” the company said.
Supernus stock $SUPN fell 18% on the news pre-market, from 24.95 to 20.35.
Expectations around the ADHD drug, however, had already begun to wane. Supernus CEO Jack Khattar has billed SPN-812 as the “first truly new therapy” for ADHD in a decade, but the results in late-stage trials fell short of expectations.
Although positive, their first cut of the Phase III study appeared to show an effect size no greater than a rival Eli Lilly drug and failed to show a dose-dependent response in the high dose, worrying investors. The company has pointed to data suggesting their treatment can work faster, with patients feeling the effect after one week as opposed to several weeks.
The SPN-830 Parkinson’s pump was part of their $300 million buyout of the Kentucky-based neuroscience company US WorldMeds. Supernus envisioned it as an alternative to more invasive procedures for patients struggling with symptoms, such as the gastric tubes sometimes used to provide continuous dosing of L-Dopa.