Austedo (deutetrabenazine)

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Austedo (deutetrabenazine)

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Neurology Huntington's Disease, Tardive Dyskenia
Marketing Authorisation Holder Teva Pharmaceuticals
Mode of Action Vesicular monoamine transporter 2 (VMAT2) inhibitor
Administration Oral
Regulatory agency approval Food and Drug Administration (FDA), USA

What is Austedo (deutetrabenazine) for?

Austedo (deutetrabenazine) is a medicine used to treat adults with chorea associated with Huntington’s disease and tardive dyskinesia1.

  • Chorea is a disorder characterised by brief, abrupt, irregular, unpredictable, non-stereotyped movements which can affect various body parts, and interfere with speech, swallowing, posture and gait2.

  • Tardive dyskinesia is a debilitating and often irreversible movement disorder characterised by repetitive and uncontrollable movements of the tongue, lips, face, trunk, and extremities. It can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions3.

How does Austedo (deutetrabenazine) work?

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor1. A VMAT2 is a protein essential for the release of neurotransmitters into the synaptic cleft — the space between neurons where the communication between neurons takes place6. The precise mechanism by which Austedo (deutetrabenazine) exerts its anti-chorea effects is unknown but it is expected to clear the nerve terminals from neurotransmitters like dopamine, serotonin, norepinephrine, and histamine. This reversible effect seems to be responsible for reducing chorea and tardive dyskinesia1.

Austedo (deutetrabenazine) is the second product approved for the treatment of Huntington’s Disease, the other one being tetrabenazine4. The two medicines have a very similar mechanism of action. The main difference between the two is that Austedo (deutetrabenazine) is metabolised more slowly and thus enables less frequent and lower daily doses, achieving the same effect whilst lowering the risk of side effects. Compared with tetrabenazine, deutetrabenazine has, thus, an improved risk-benefit profile5.

Is Austedo (deutetrabenazine) approved?

Austedo (deutetrabenazine) was approved by:

  • Food and Drug Administration (FDA) (USA):
    • April 3, 2017 (chorea associated with Huntington’s Disease4)
    • August 30, 2017 (treatment of Tardive Dyskinesia3)

How do I take Austedo (deutetrabenazine)?

The dose of Austedo (deutetrabenazine) is determined for each patient based on the reduction of chorea or tardive dyskinesia, and tolerability1.

The recommended starting dose of Austedo (deutetrabenazine) is:

  • 6 mg administered orally once daily for patients with Huntington’s disease

  • 12 mg per day (6 mg twice daily) for patients with tardive dyskinesia.

The dosage has to be adjusted according to the patient's treatment history.

Patients who are not switching from tetrabenazine

When prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor)1:

  • increase the dose at weekly intervals in increments of 6 mg per day to a maximum recommended daily dosage of 48 mg

  • total daily dosages of 12 mg or above should be administered in two divided doses

  • administer with food and swallow whole. Do not chew, crush, or break tablets.

Patients who are switching from tetrabenazine

Patients who are taking tetrabenazine and are switching to Austedo (deutetrabenazine) should discontinue tetrabenazine and initiate Austedo the following day. The recommended initial dosing depends on the current tetrabenazine daily dosage. Detailed information can be found on the FDA official prescribing information on page 21.

Complete information about Austedo (deutetrabenazine) dosage and administration can be found in the resources section1.

Warning: Austedo (deutetrabenazine) can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of Austedo (deutetrabenazine) must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Austedo (deutetrabenazine)?

Common side effects

Chorea associated with Huntington’s Disease

The most common adverse reactions occurring in more than 8% of Austedo-treated patients1  for chorea associated with Huntington’s disease were:

  • somnolence

  • diarrhoea

  • dry mouth

  • fatigue.

There was no difference in the number of adverse events among the two groups overall and within psychiatric and nervous system areas, with serious adverse events in one patient per group5.

Tardive Dyskinesia

The most common adverse reactions occurring in more than 8% of Austedo-treated patients1  for Tardive Dyskinesia1 were:
  • nasopharyngitis

  • insomnia.

Serious side effects

The serious side effects listed in the prescribing information include:

  • increases the risk of depression and suicidal thoughts and behaviour (suicidality)
    in patients with Huntington’s disease

  • QT Prolongation (abnormal heart rhythm)

  • neuroleptic malignant syndrome (NMS)

  • akathisia, agitation, restlessness, and parkinsonism

  • sedation/somnolence.

Use in a specific population

Austedo (deutetrabenazine) can be fatal for a fetus.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.

More Information
Working ingredient deutetrabenazine
Shipping method Controlled room temperature (temperature controlled)
Therapeutic Area Neurology
Neurology Huntington's Disease, Tardive Dyskenia
Indication Chorea associated with Huntington’s disease
Indication Tardive dyskinesia
Administration Oral
Mode of Action Vesicular monoamine transporter 2 (VMAT2) inhibitor
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Teva Pharmaceuticals
HS Code N/A
CAS Number N/A

Chorea associated with Huntington’s Disease

The efficacy of Austedo (deutetrabenazine) in the treatment of chorea associated with Huntington's disease was established in a trial that compared Austedo (deutetrabenazine) with placebo (a substance with no therapeutic effect).

  • The study involved 90 patients with manifest chorea associated with Huntington’s disease but with maintained walking ability1,5.

  • The study lasted 13 weeks – 12 weeks of treatment and 1 final week of treatment interruption (washout). The 12 weeks of treatment consisted of 8 weeks of gradual dosage increase (titration) and 4 weeks of maintenance1,5.

  • The initial dose for patients on Austedo (deutetrabenazine) was 6 mg per day and it was incremented at weekly intervals with increments of 6 mg until satisfactory treatment of chorea was achieved, intolerable side effects occurred, or until a maximal dose of 48 mg per day was reached1,5.

The two patient groups (placebo and deutetrabenazine) were compared on the basis of the scores achieved on different scales.

Results

The most important measure was the change in the total maximal chorea score from the beginning of the study (baseline). The total maximal chorea score ranges from 0 to 28, where a lower score indicates less chorea. It is given by the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 extremities), each of which is scored on a scale from 0 to 4 (0 = absent; 1 = slight or intermittent; 2 = mild and common or moderate and intermittent; 3 = moderate and common; and 4 = marked and prolonged). Among the other scales used to monitor the patients were the Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), the 36-Item Short Form Health Survey (SF-36) physical functioning subscale score, and Berg Balance Test. The PGIC and CGIC are scales designed to assess the effects of treatment as perceived by patients and clinicians, respectively. The SF36 is a survey on patient health, and the Berg Balance Test is a clinical test of a person's static and dynamic balance abilities5.

  • Austedo resulted better than placebo in all tests except the Berg Balance Test.

  • The difference in improvement in total maximal chorea score between the two groups was significantly in favour of Austedo (deutetrabenazine): patients in the deutetrabenazine group had a mean of –4.4 (95 % CI, –5.3 to –3.6) improvement in total maximal chorea score, whereas the placebo group improved by –1.9 (95% CI, –2.8 to –1.1).

  • Following the treatment interruption (washout), chorea returned to the level it was before the study started1,5.

  • In the deutetrabenazine group 51% of patients reported treatment success by the PGIC scale versus 20% in the placebo group. Similarly, 42% of patients in the deutetrabenazine group reported treatment success using the CGIC scale vs 13% of patients in the placebo group.

  • The SF-36 physical functioning subscale improved by 0.7 (95% CI, –2.0 to 3.4) for deutetrabenazine and worsened by –3.6 (95% CI, –6.4 to –0.8) for the placebo group. There was no significant difference in improvement in Berg Balance Test1,5.

Tardive Dyskinesia

The efficacy of Austedo (deutetrabenazine) in the treatment of tardive dyskinesia was established in 2 X 12 week, randomised, double-blind, placebo-controlled, multicentre trials conducted in 335 adult ambulatory patients with tardive dyskinesia caused by the use of antipsychotics (dopamine receptor antagonists)1.

Results

The most important measure in both studies was the change in Abnormal Involuntary Movement Scale (AIMS). The AIMS is a 12 item scale for the assessment of tardive dyskinesia severity. The first 7 items assess the severity of involuntary movements across body regions and these items were used in this study1.

Each of the 7 items was scored on a 0 to 4 scale, with 0 = not present and 4 = severe (abnormal movements occur almost continuously and/or of extreme intensity). The AIMS total score across the 7 considered items could thus range from 0 to 28, with a decrease in score indicating improvement1.

Study 1 involved 222 patients who were divided into 4 groups: 1 group took placebo and the other 3 took Austedo (deutetrabenazine). The treatment included a 4 weeks dose escalation, 8 weeks of maintenance and 1 final week of treatment interruption (washout). Of those that took Austedo, a first group took 12 mg daily for the whole duration of the study, a second group started with 12 mg daily and increased to 24 mg daily, and a third group started with 12 mg daily up to 36 mg daily. Patients receiving the 24 mg and the 36 mg dose had an improvement in the AIMS score of 3.3 and 3.2 units respectively, compared with 1.4 units in the place group1.

Study 2 involved 113 patients. It lasted for 12 weeks, during which Austedo was tested against placebo, adjusting the dose from 12 mg with increases allowed in 6 mg increments at 1 week intervals until satisfactory control of dyskinesia was achieved, intolerable side effects occurred, or a maximal dose of 48 mg per day was reached. The AIMS total score for patients receiving Austedo demonstrated a statistically significant improvement of 3.0 units from baseline to endpoint (week 12), compared with 1.6 units in the placebo group1.

1.Summary of Product Characteristics [FDA]: Austedo (deutetrabenazine) [PDF]
   Teva Pharmaceuticals, austedo.com, April 2017

2.The International Parkinson and Movement Disorder Society Chorea & Huntington's Disease
   movementdisorders.org, cited Nov 2017

3.Drugs.com. Teva announces FDA approval of Austedo (deutetrabenazine) tablets for the treatment of tardive       dyskinesia in adults
  Drugs.com, cited Dec 2017

4.Drugs.com. FDA approves Austedo
   drugs.com, cited Dec 2017

5.Huntington Study Group. Effect of deutetrabenazine on chorea among patients with Huntington disease. A     randomized clinical trial.
  JAMA. jamanetwork.com, July 2016.

6.Wikipedia. Vesicular monoamine transporter 2
   www.wikipedia.com, cited Dec 2017


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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.