Parkinson’s Disease Treatment Under FDA Review

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CNN recently reported that the hopes of those who have loved ones suffering from Parkinson’s disease may have been dashed. An experimental drug called Nuplazid was heralded as a breakthrough therapy for those suffering from Parkinson’s disease and was pushed through a fast-tracked FDA approval process in 2012. Those advocating for the drug begged the FDA to expedite its review because of its potential to make a real difference in the lives of patients suffering from Parkinson’s disease. They were desperate to literally try anything so that their loved ones could regain a sense of a normal life and suffer a little less at the hands of this debilitating disease.

The major concern with this new drug is that death remained as one of the side effects. In the clinical trials involving a placebo, the rate of death among those patients taking Nuplazid was nearly double that of the placebo group. Despite the risky side effects, Nuplazid was released on the market in June 2016. Pharmaceutical sales of this drug reached a height of $125 million by 2017. Some of those patients who tried the drug started to report that they were not experiencing any improvement in symptoms of Parkinson’s disease and were also experiencing serious side effects, including vivid and dangerous hallucinations quite frequently. By November 2017, more than 240 deaths in the U.S. had been reported among those taking the drug.

The drug is produced by Acadia Pharmaceuticals. The company has gone on record multiple times that the potential benefits of the drug far outweigh the potential side effects, especially in light of the devastating effect that Parkinson’s disease has on those who suffer from it. Despite the incredibly high death toll associated with Nuplazid, Acadia has lobbied the FDA to continue its approval of the drug. The response from the FDA so far has been to confirm that it will continue monitoring all adverse event reports from this drug and takes any report of death associated with Nuplazid very seriously. However, the FDA maintains that the risk of death is clearly outlined in the product’s label, which means that no patient taking the drug should be doing so without carefully considering death as a potential outcome. Even with the harmful side effects associate with Nuplazid, the cost is prohibitive for many patients from being able to try the drug. The consumer representative on the FDA panel said she voted against its approval.

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