Teva Pharmaceutical Industries (NYSE:TEVA) announced Wednesday that two late-stage clinical trials evaluating deutetrabenazine (also known as Austedo) for use in patients with Tourette syndrome failed to meet its clinical endpoints.
A Phase 2/3 Artists 1 trial and Phase 3 Artists 2 trial were testing Teva's drug deutetrabenazine in pediatric patients with moderate to severe cases of Tourette syndrome. Tourette's is a type of neurodevelopmental disorder that typically begins in childhood, and is characterized by uncontrollable movements and sounds (tics). Approximately one to 10 out of every 1,000 children are diagnosed with some form of Tourette's.
The trials sought to evaluate whether Teva's drug could help reduce the number and severity of these tics in comparison to a placebo. Although the safety profile remained solid for the drug, with the most common adverse events including headaches and fatigue, the results failed to meet the primary endpoint of the study.
Previous FDA approvals
Deutetrabenazine received U.S. Food and Drug Administration (FDA) approval back in 2017 to treat two separate conditions that also involve involuntary spasms and movements. The first, Huntington's disease, is a brain disorder that results in uncontrollable movements as well as emotional and thinking problems.
The second condition the FDA approved deutetrabenazine for, tardive dyskinesia, is a frequent side effect from taking antipsychotic medications.
Last week, Teva announced its fourth quarter financial results. While the results weren't that impressive, with total annual revenue falling by 8% to just $16.9, the pharmaceutical company is making progress in paying off its debts.