People who suffer the effects of tardive dyskinesia may have reason to celebrate. The FDA has approved the first drug for this disruptive disorder.
Over 1,000 persons, participating in 20 clinical trials made the Ingrezza™ program the largest study in tardive dyskinesia; ever. The study’s conclusion revealed patients experienced significantly decreased symptoms after six weeks.
Neurocrine Biosciences, Inc. received approval of Ingrezza™ (valbenazine) capsules on April 11, 2017. The product is intended for use by adults who reside in the United States.
Before Ingrezza™, those suffering from tardive dyskinesia were limited to discontinuing or changing medications needed for psychiatric disorders, or alternate drugs that might reduce symptoms. While these options may be useful, none were specifically developed for use with these patient group.
Tardive Dyskinesia Symptoms and Information
This is a congenital/genetic neurological disorder, which is not rare, according to the U.S. Department of Health and Human Services website.
Tardive dyskinesia is primarily characterized by repetitive involuntary movements of the jaw, lips and tongue such as grimacing; sticking out the tongue; and smacking, puckering and pursing the lips.
Some affected people may also experience involuntary rapid, jerking movements (chorea) or slow, writhing movements (athetosis) of the arms and/or legs.
These symptoms are associated with chronic use of dopamine receptor blockers and can be persistent, severe, and irreversible. For some, the condition can obstruct a person’s speech, their ability to walk, swallow, and breathe.
As many as 500,000 people in the United States are believed to be afflicted with tardive dyskinesia. To date, researchers do not understand why some people develop after long-term use of certain psychiatric drugs and others do not. While there is the possibility of discovering the genetic marker, as of March 10, there is no information on the Human Phenotype Ontology database indicating one has been identified.
Most affected patients have used the antipsychotic, aka neuroleptic, medications for many years, whereas, some experience the symptoms after taking them for a shorter period. Those who are schizophrenic or have bipolar disorder are treated with these pharmaceuticals and are the portion of the population likely to develop tardive dyskinesia.
These medications include, but are not limited to, Abilify®, aripiprazole; Clozaril®, clozapine; Geodon®, ziprasidone; Latuda®, lurasidone; Risperdal®, risperidone; Saphris®, asenapine; Seroquel®, quetiapine; and Zyprexa®, olanzapine, according to Department of Developmental Services.
A secondary group of drugs, non-neuroleptics, linked to tardive dyskinesia, includes those prescribed for other medical disorders:
- Triavil®, perphenazine/amitriptyline;
- Reglan®, metoclopramide;
- Aventyl®, nortriptyline;
- Elavil®, amitriptyline.
The prognosis for those with tardive dyskinesia is varied. When diagnosed early, patients may experience fewer symptoms after discontinuing the medication causing the condition. However, stopping the offending drug is not always effective. In some cases, people will continue to suffer adverse effects, which could become increasingly troublesome.
Patients are initially prescribed a daily dose of a 40 mg capsule for the first week, and the dosage may be increased to 80 mg beginning the second. Complete prescriber and consumer information can be found on the Ingrezza™ website.
Participants in the clinical study continued to use their previously prescribed medications, which included a broad range of psychotropic and other concomitant drugs. Researchers found no drug-drug interactions.
As with most medications, users are reminded to refrain from operating heavy equipment or driving until they know how Ingrezza™ affects them. Fewer than 5 percent, of the study participants, suffered from somnolence, which is a strong desire for sleep or sleeping for unusually long periods.
Currently, there is no news about when this medication will be made available for prescription, although those in the study were given Ingrezza™ to maintain the success achieved during its testing.
By Cathy Milne
U.S. Food and Drug Administration: FDA approves first drug to treat tardive dyskinesia
Neurocrine Biosciences: NEUROCRINE ANNOUNCES FDA APPROVAL OF INGREZZA TM (VALBENAZINE) CAPSULES AS THE FIRST AND ONLY APPROVED TREATMENT FOR ADULTS WITH TARDIVE DYSKINESIA (TD)
Ingrezza: HIGHLIGHTS OF PRESCRIBING INFORMATION
U.S. Department of Health and Human Services: Tardive Dyskinesia
Ct.gov Department of Developmental Services: DDS MEDICAL ADVISORY #2000-2
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