By Katrina Hapner Contributing Writer for Telegraph Local
There is hope on the horizon for patient’s suffering from dementia-related psychosis. On Wednesday evening, at a meeting of the Clinical Trials On Alzheimer’s Disease in San Diego, it was announced that the FDA has bestowed Breakthrough Therapy classification for the drug Nuplazid for treatment of dementia-related psychosis. Nuplazid has previously been used to treat delusions and hallucinations that are known to occur with Parkinson’s disease. If Nuplazid does go on to be approved by the FDA, it would be the very first drug approved for the treatment of dementia-related psychosis.
Arcadia, the maker’s of Nuplazid say that they will apply for approval in 2020 for their drug to be used in the treatment of dementia-related psychosis. Acadia says it will seek approval for the drug to treat dementia-related psychosis in 2020. Subsequent to this announcement, shares of Arcadia Pharmaceuticals rose 6.62 points as of Thursday morning.
Breakthrough Therapy designation is for the purpose of expediting the review process of drugs that have been shown, through clinical evidence, to deliver substantial improvement of serious conditions. According Dr. Jeffrey Cummings, Director of the Cleveland Clinic Center for Brain Health, in a statement on the Arcadia website, “The results presented today are an important advance for patients and caregivers who struggle with the burden of dementia-related psychosis where no FDA-approved treatment is currently available.” He goes on to say, “Reducing the risk of relapse of psychotic symptoms by this magnitude is an important and meaningful outcome as these are serious events which could lead to poor patient outcomes and a significant increase in caregiver burden and distress.”
In a clinical study known as Harmony, 392 patients were given Nuplazid for 26 weeks. It was shown during the first 12 week period that Nuplazid significantly decreased and stabilized symptoms associated with dementia-related psychosis. Over the entire 26 week period, it was shown Nuplazid was tolerated very well by trial participants and that while taking Nuplazid, patients had nearly a three-fold reduction in psychotic relapse as compared to patients taking a placebo. Nuplazid is classified as a selective serotonin inverse agonist and antagonist, said to target dopamine receptors that are affected in psychosis, depression, and even schizophrenia among other neurologic disorders.
In the United States alone, nearly 8 million people are dealing with dementia, and clinicians say that about 30 percent of those Americans have some form of psychosis in the form of delusions and hallucinations. People with dementia disorders such as Alzheimer’s Disease, often suffer with psychosis, which increases hospital admissions and also forces families to turn to nursing home placement for their loved ones who otherwise could be cared for at home. The Alzheimer’s Association suggests that the costs of this disease is approximately $341,000 to care for the needs of someone with Alzheimer’s disease from onset of symptoms to death and that is projected to rise dramatically by 2050.