 |
In April, the Food and Drug Administration approved Ingrezza (valbenazine) capsules to treat adults with TD—a serious side effect associated with chronic use of antipsychotics—making it the first FDA-approved product for the condition. This approval was based in part on the results of a six-week trial, which compared changes in involuntary movements in patients with moderate-to-severe TD who took valbenazine (40 mg/day or 80 mg/day) or with those taking placebo daily. As was reported in the American Journal of Psychiatry (May 2017), treatment with valbenazine resulted in a significant reduction in patients’ Abnormal Involuntary Movement Scale (AIMS) dyskinesia score compared with placebo.
In the current study, Stuart A. Factor, D.O., of Emory University and colleagues tracked the long-term outcomes of 198 patients who entered a 42-week valbenazine extension period following the initial six-week trial. Safety assessments included treatment-emergent adverse events (TEAEs) and scales for suicidal ideation/behavior, treatment-emergent akathisia or parkinsonism, and psychiatric symptoms. Efficacy assessments included the AIMS and Clinical Global Impression of Change-Tardive Dyskinesia.
Of the 198 patients who entered the valbenazine extension period, 124 (62.6%) completed the 42-week treatment. During the extension period, 69.2% of participants had more than one TEAE, but the only events leading to study discontinuation in more than two participants were somnolence (n=3) and suicidal ideation (n=3). (The cases of suicidal ideation were treated and deemed to be unrelated to valbenazine, according to the report.) The incidence of “serious” TEAEs was 14.6 percent, with syncope the only serious TEAE reported in more than two participants.
TD improvement with valbenazine was sustained throughout the extension period, with statistically significant improvements relative to baseline in both dose groups. During a four-week washout period following discontinuation of valbenazine, AIMS scores increased, indicating that TD symptoms tended to return to baseline. The findings suggest that ongoing valbenazine treatment may be required to maintain TD improvements, according to the authors.
“Results of this extension study generally indicated that valbenazine was safe and well tolerated, and maintenance of treatment effect was apparent for both doses,” the authors wrote. “Further research is needed to better understand the long-term effects of valbenazine on TD and to identify the types of patients who might benefit most from this novel medication.”
For related information, see the Psychiatric News story “The Valbenazine Story: Small Company Makes Big Breakthrough.”
Tell Congress: Tax Cuts Shouldn't Hurt Patients
Congress is forging ahead with passing major tax reform that threatens patients' access to health care. The House-passed proposal takes away the medical expense deduction that helps some patients pay for their appointments, stays in inpatient psychiatric or substance use facilities, and medications. The Senate’s proposal calls for the repeal of the Affordable Care Act’s individual mandate, which would cause the number of uninsured Americans to increase by an estimated 13 million by 2027 and ultimately result in skyrocketing premium increases.
The Senate is expected to vote on their reform package the first week of December. That means there is time for you to voice your opposition to tax reform proposals that harm access to mental health care. Write your federal lawmakers today!
(Image: iStock/Saklakova)