Teva’s Austedo fails in two paediatric Tourette’s syndrome trials

pharmafile | February 21, 2020 | News story | Medical Communications, Research and Development |  Austedo, Teva, pharma, tourette’s 

Israeli firm Teva has shared disappointing results for its vesicular monoamine transporter 2 (VMAT2) Austedo (deutetrabenazine) after it failed to meet its primary endpoint two clinical trials at Phases 2/3 and 3 in the treatment of paediatric patients with moderate to severe Tourette’s Syndrome

In the studies, it was found that Austedo failed to reduce motor and phonic tics – the primary endpoint of the trials – compared to placebo, as measured on the Total Tic Score of the Yale Global Tic Severity Scale.

Tourette’s syndrome is characterised by compulsive movement tics such as specific facial motions, sniffing, coughing, blinking or, in a small number of cases, uttering obscenities.   

The drug has already secured approval from the FDA for chorea associated with Huntington’s disease and for tardive dyskinesia. Teva picked up the therapy in 2015, handing over $3.5 billion to Auspex Pharma for the rights.

“The results of the trials are disappointing, especially as there is such an unmet need for this community of paediatric patients,” said Hafrun Fridriksdottir, Executive Vice President of Global R&D at Teva. “As we assess a path forward, Teva is especially grateful to the investigators, patients and families who contributed to these studies for such an important patient population.”

Matt Fellows