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Teva drug shows promise in movement disorder

Deutetrabenazine could be the first US-approved drug for tardive dyskinesia 

Teva Pharma logo 

A drug in development at Teva has helped control symptoms of the movement disorder tardive dyskinesia (TD), for which there is no approved therapy in the US.

The results of the phase III trial of deutetrabenazine (SD-809) - a VMAT2 inhibitor acquired by Teva when it bought Auspex Pharma for $3.5bn in March - showed the oral drug reduce the involuntary movements that characterise TD, such as facial grimacing and repetitive twitching of the limbs.

Around 500,000 people in the US suffer from TD, which often develops as a complication of psychoactive drugs used to treat mental illnesses such as schizophrenia and bipolar disease and the gastrointestinal therapy metoclopramide.

Top-line results from the ARM-TD trial involving 117 patients with moderate-to-severe TD showed that after 12 weeks' therapy, deutetrabenazine achieved an improvement of three points on the Abnormal Involuntary Movement Scale (AIMS), compared to a 1.6-point gain for placebo.

Teva also said that deutetrabenazine showed a positive trend on secondary outcome measures, it did not go into details and said it would share the full data set at a medical congress in future.

"There is a serious and growing medical need as TD is one of the most debilitating and often irreversible side effects of dopamine receptor blocking agents, which are increasingly being used in the US," said the trial's principal investigator Hubert Fernandez of the Cleveland Clinic.

"With no approved treatments of this serious condition currently available, the need for a therapeutic solution is urgent and overdue," he added.

While there is no FDA-approved drug for TD, the drug from which Teva's candidate is derived - Lundbeck's Xenazine (tetrabenazine) - has been used off-label to treat symptoms but is associated with its own side effects such as akathisia, a compulsion to pace back and forth, anxiety, Parkinsonism and depression. 

Teva's drug is a 'deuterated' form of the molecule that changes its chemical structure in an attempt to improve safety and efficacy. In the ARM-TD trial, the drug was associated with "low rates of depression, somnolence, insomnia and akathisia," according to the company.

Tetrabenazine is approved as an orphan drug in the US to treat chorea (involuntary movements) associated with Huntington's disease, and brought in around $245m in sales for Lundbeck last year thanks to its price tag of around $85,000 a year. However, Teva estimates that because of side effects only 5% of eligible patients are actually treated with the drug.

Teva is also testing deutetrabenazine in Huntington's chorea, and has completed a phase III study with a marketing application pending. It also has late-stage trials ongoing in chorea associated with Tourette's syndrome. 

The Israeli company is hoping it may be able to use a shorter regulatory pathway in the US - known as the 505(b)(2) route - that would allow it to reference Lundbeck data in its dossier and could mean deutetrabenazine reaches the market next year.

Article by
Phil Taylor

17th June 2015

From: Research



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