Bexicaserin Improves Seizure Control in DEEs, SPN-830 Approved for Parkinson Disease, Self-Administration Rozanolixizumab Gains EU Approval

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

Newly announced 12-month data from the phase 1b/2a PACIFIC trial showed that treatment with investigational bexicaserin (Lundbeck) resulted in significant reductions in countable motor seizures in patients with developmental and epileptic encephalopathies (DEEs). The PACIFIC OLE was a 52-week, phase 2, open-label, long-term safety study of bexicaserin in patients with a range of DEEs, including Dravet syndrome (n = 3), Lennox-Gastaut syndrome (n = 20), and DEE other (n = 18), who completed the original PACIFIC trial (n = 41). In the open-label extension (OLE) period, treatment with bexicaserin resulted in an overall median seizure reduction of 59.3% in countable motor seizures over the 12-month timeframe. Among those who were originally randomized to bexicasein in the core PACIFIC trial that continued treatment in the OLE, the median seizure decrease was 60.4% (n = 31) in the OLE.

Nearly 4 and a half years since its original submission, the FDA has approved Supernus Pharmaceuticals’ investigational agent SPN-830 (Onapgo) as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD). The therapy’s approval was based on data from the TOLEDO study (NCT02006121), a randomized, double-blind study in which treatment with the device was associated with a difference of –1.89 hours per day of OFF time for patients with PD in comparison with placebo. Published in the Lancet Neurology in 2018, the study randomly assigned 106 patients living with the disease to either 3-mg/hour to 8-mg/hour dose of apomorphine (n = 53) or placebo saline infusion (n = 53) during their wake hours for a 12-week period.

According to a recent announcement, UCB’s rozanolixizumab (Rystiggo), a medication for various forms of myasthenia gravis (MG), has gained EU approval for 2 new self-administration methods, including an infusion pump or manual push with a syringe. The belief is that the new self-administered subcutaneous treatment may offer several advantages, including high patient satisfaction, sense of control, and increased independence. Rozanolixizumab is a humanized high-affinity, anti-human neonatal Fc receptor (FcRn) monoclonal antibody targeting immunoglobulin G. The newly approved self-administration methods were based on data from a phase 3, open-label, crossover study (NCT05681715) in which patients were randomly assigned to once-weekly rozanolixizumab for 18 consecutive weeks consisting of a 6-week self-administration training period, followed by two 6-week self-administration periods.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.