New Guideline for Tourette Syndrome, Tic Disorders, FDA Approves sBLA for IncobotulinumtoxinA for Blepharospasm, Gaboxadol Shows Clinical Benefit in Angelman Syndrome

This week, Neurology News Network covered the new treatment guidelines from the American Academy of Neurology for Tourette syndrome and tic disorders which emphasizes behavioral therapy as a first-line intervention, the FDA approval of a supplemental Biologics License Application for incobotulinumtoxinA as a first-line treatment for blepharospasm in adults, and the phase 2 STARS trial which for the first time in 50 years showed that an overall improvement in patients with Angelman syndrome was observed, in this instance with a once-daily dose of gaboxadol. (Transcript below)

Jenna:

Welcome to Neurology News Network. I’m Jenna Payesko. Let’s get into the news from this week.

For patients with Tourette syndrome and other chronic tic disorders, a treatment approach that includes holistic and behavioral strategies, as well as medications may help improve tic management over time, according to new treatment guidelines from the American Academy of Neurology. The guidelines, which are endorsed by the Child Neurology Society and the European Academy of Neurology, place strong emphasis on the need for clinicians to educate patients and their caregivers about the natural history of tic disorders.

The FDA has approved a supplemental Biologics License Application for incobotulinumtoxinA as a first-line treatment for blepharospasm in adults. The sBLA approval was backed by data from a phase 3, randomized, placebo-controlled trial that studied the efficacy and safety of 2 different doses of incobotulinumtoxinA in patients with bilateral blepharospasm.

The FDA previously approved the drug for the treatment of blepharospasm and cervical dystonia in adults in 2010, and added indications for upper limb spasticity in adults in 2015 and chronic see-a-lo-rhea in adults in 2018.

For the first time in almost 50 years, overall clinical benefit has been demonstrated in patients with Angelman syndrome, a rare neurodevelopmental condition with no approved therapies, who were treated with gaboxadol, also known as OV101.

In the phase 2, randomized, double-blind, placebo-controlled STARS trial of Ovid Therapeutics’ highly selective extrasynaptic GABA receptor agonist, global improvement was observed at week 12 with a once-daily, 15-mg dose compared to placebo, as measured by the Clinical Global Impressions-Improvement scale.

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