Tardive Dyskinesia - Ingrezza

Tardive Dyskinesia complicates treatment with atypical antipsychotic drugs including Abilify, Risperdal, Zyprexa, Seroquel, Vraylar and Latuda. While the incidence may be slightly less than with the original antipsychotics: Haldol, Stelazine, Serentil, Prolixin, Navane and Trilafon; both classes place individuals at significant risk.

An estimated 500,000 individuals may already experience tardive dyskinesia. Manifestations range from subtle, almost imperceptible, involuntary movements of the lips, mouth, tongue or the area around the forehead and eye to more obvious, repetitive and distracting changes. Some estimates suggest after 1 year of therapy with antipsychotics the incidence approximates 5% with the incidence rising to 25% after 5 years of therapy. Discontinuing therapy seldom relieves the burden which tends to persist indefinitely.

Antipsychotics remain a primary treatment for schizophrenia and increasingly for mania associated with bipolar disorder. Unfortunately this class of drugs seems increasingly prescribed for indications lacking FDA approval and for which many safer therapies exist.

Until Ingrezza received FDA authorization for treatment of Tardive Dyskinesia, no other licensed pharmaceutical was available specifically for this purpose. Treatment begins at a dose of 40 mg once daily and after a week continues at 80 mg daily. Studies presented to the FDA demonstrated a moderate but rarely dramatic improvement in symptoms. Patients seldom benefit by total resolution of their involuntary movements with 1 in 4 showing no change or worsening of the condition. Additionally the lower dose does not appear to be superior compared to an inactive placebo.

Side effects include somnolence, fatigue, sedation and falls related to balance disorders. During an almost 1 year study 1 in 6 participants discontinued the drug as a consequence of adverse reactions. Even for a drug only approved in 2017, the FDA Adverse Event Reporting System has received notice of 116 deaths among individuals receiving Ingrezza. These events do not necessarily represent a cause and effect relationship but fewer than 10% of all complications of therapy are included in the database.

On review of the drug the non-profit rating agency, the Institute for Clinical and Economic Review, suggests the company needs to reduce the wholesale acquisition cost by 85-90% to bring it in line with reality. At present the daily cash price of Ingrezza according to goodrx.com exceeds $260 a day for an average yearly cost above $82,000.
And all this as the result of our excessive use of relatively inexpensive antipsychotics for which safer alternatives often exist.