Teva’s Austedo XR receives FDA approval for tardive dyskinesia

Teva Pharmaceuticals has received US Food and Drug Administration (FDA) approval for the long-acting drug Austedo XR (deutetrabenazine) for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease.

The new Austedo XR once daily is now approved in extended release tablets at 6 mg, 12 mg and 24 mg with or without food.

Tardive dyskinesia (TD) is a movement disorder that causes a series of repetitive, uncontrolled movements of the muscles of the face, neck, arms, and legs. The disease significantly affects the quality of life.

Although TD is sometimes associated with conditions such as schizophrenia in the first place, it occurs as a side effect of long-term use of certain medications. The condition can become irreversible even after the person stops taking the drugs.

Huntington’s disease (HD) is a rare inherited disorder that causes progressive destruction (degeneration) of nerve cells in the brain. HD has a wide impact on a person’s functional abilities and usually leads to motor, thinking (cognitive) and mental disorders.

Symptoms of HD can develop at any time, but they often first appear in people in their 30s or 40s. If the disease develops before the age of 20, it is called juvenile HD. When the disease develops early, the symptoms are somewhat different and it may progress more rapidly. There are medications available to help manage the symptoms of HD. But treatment cannot prevent physical, mental and behavioral deterioration.

The FDA has now approved an additional, innovative twice-daily formulation of Austedo.

According to Teva, Austedo is the only vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of HD-related TD and chorea.

The company also stated that Austedo XR, taken once a day, was therapeutically equivalent to a drug taken twice a day.

Teva intends to make the Austedo XR available in the US later this year.