Austedo- Reduction of the mean AIMS score was observed at Week 2 (1.7 ± 0.17)
- Results were sustained throughout the long term with an AIMS reduction of 6.8 at Week 145
- Adverse events over the long-term period were comparable to those in the pivotal trials
Efficacy demonstrated for both
indications
Select condition:
Significant and meaningful tardive dyskinesia (TD) symptom control at multiple doses with AUSTEDO (deutetrabenazine) tablets
AUSTEDO significantly reduced Abnormal Involuntary Movement Scale (AIMS) total score by 3.3 points from baseline in the 36 mg/day arm (vs 1.4 with placebo) at Week 12 (P<0.05).1, 2
AIM-TD: Change in AIMS Total Score from Baseline to Week 12 (N=222)1, 2
RAPID RESPONSE:
Significant AIMS total score reduction was seen by Week 2 (exploratory analysis).1-3
OPEN-LABEL EXTENSION STUDY
AIMS score reduction observed throughout 145 weeks
Sustained results in an open-label extension study3,4
Mean Change in AIMS Score Over the Long-Term Period3
The mean total daily dose of AUSTEDO was 38.8 mg from the ARM-TD pivotal trial and 39.5 mg at Week 145 of the long-term period.3
- After the pivotal trials, all patients completed a 1-week washout and then started on AUSTEDO at 12 mg/day, which was adjusted once per week in increments of 6 mg/day to identify a dose that adequately controlled dyskinesia and was tolerated by the patient4
The mean overall compliance rate was 90.2% for patients on a BID regimen of AUSTEDO at 2 years in the open-label extension study.3,4*
*Overall compliance based on pill counts.
41% of patients in the 36 mg/day arm had a ≥4-point improvement in AIMS total score vs 25% in the placebo arm1
AIM-TD: Response to Treatment Across Dosing Arms at Week 12 (N=222)1, 3
PIVOTAL TRIAL: ARM-TD
Significant and meaningful control of TD symptoms at Week 12 (P=0.019) with AUSTEDO
Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period1,5
ARM-TD: Change in AIMS Total Score from Baseline to Week 12 (N=113)1, 5
In ARM-TD
- A 6-week titration dosing strategy was utilized (initial dose of 12 mg/day, divided into 2 daily doses taken with food, titrated weekly by 6 mg/day for a max dose of 48 mg/day), followed by 6 weeks of maintenance therapy1,5
- The maximum dose for patients taking a strong CYP2D6 inhibitor was 36 mg/day
In this study, discontinuation due to adverse events occurred in 1 patient (1.7%) in the AUSTEDO group and 2 patients (3.4%) in the placebo group.5
STUDY-RESULTS
In the AIM-TD and ARM-TD pivotal trials1,3:
- Control of TD symptoms was achieved while psychiatric scale scores, as measured by C-SSRS and HADS, generally remained stable
- 4% of patients required dose reductions of AUSTEDO vs 2% of patients taking placebo
C-SSRS, Columbia-Suicide Severity Rating Scale; HADS, Hospital Anxiety and Depression Scale.
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AUSTEDO® (deutetrabenazine) tablets Copay Program Terms and Conditions
Terms, Conditions and Eligibility Requirements
To the Patient:
To redeem this offer, you must have a valid prescription for AUSTEDO®. No substitutions permitted. Commercially insured patients with coverage for AUSTEDO® may pay no out-of-pocket costs. Commercially insured patients whose insurer requires a prior authorization for AUSTEDO® may receive a 30 day supply of AUSTEDO® (up to a total of three prescriptions with only one prescription per AUSTEDO® strength or NDC) under the Program while their prior authorization is pending. If the prior authorization is approved by the commercial insurer, then the individual remains eligible for the Program. If the prior authorization is denied by the commercial insurer, then the individual is no longer eligible for this Program and may not receive any additional Program benefits. Maximum annual benefits apply and out-of-pocket expenses may vary. Patient is responsible for costs above maximum benefit amounts. If you have any questions regarding your eligibility or benefits, please call the AUSTEDO® Copay Program at 1-800-887-8100.
You are not eligible for this offer if your prescriptions are paid for in part or full by any state or federally funded programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, TRICARE, or by private health benefit programs which reimburse you for the entire cost of your prescription drugs. This offer is not valid for patients who are Medicare eligible and are enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (i.e., patients who are eligible for Medicare Part D but receive a prescription drug benefit through a former employer). You are not eligible for this offer if you are uninsured or a cash-paying patient. This offer is void in California if an AB-rated generic drug is available for the product. By redeeming this offer, you acknowledge that you are an eligible patient and you understand and agree to comply with the terms and if copied, transferred, purchased, altered or traded and where prohibited and restricted by law. conditions of this offer. Void if copied, transferred, purchased, altered or traded and where prohibited and restricted by law. Program managed by PSKW, LLC on behalf of Teva Pharmaceuticals. The parties reserve the right to change or discontinue this offer at any time without notice. This offer is not health insurance.
This offer is restricted to residents of the United States and Puerto Rico and valid only at participating pharmacies. This offer is limited to one per customer and may not be used with any other discount, coupon or offer. Offer expires December 31, 2019.
To the Pharmacist:When you apply this offer, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental program for this prescription.
Pharmacist Instructions: Submit claim to Therapy First Plus. If primary coverage exists, input offer information as secondary coverage and transmit using the COB segment of the NCPDP transaction.
For questions regarding processing, please call the Help Desk 1-800-422-5604 .
AUS-41403 December 2018
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References: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc. 2. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. Published online June 28, 2017. doi: 10.1016/S2215-0366(17)30236-5 3. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 4. Fernandez HH, Stamler D, Davis MD, et al. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019;90(12):1317–1323. doi:10.1136/jnnp-2018-319918 5. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: The ARM-TD study. Neurology. 2017;88(21):2003–2010. doi: 10.1212/WNL.0000000000003960