Photo by Louis Reed on Unsplash

    I was pleasantly surprised to read this article stating the FDA approval for a new drug trial for schizophrenia. Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process.

    Schizophrenia is a complicated chronic disease affecting approximately 3.5 million people in the United States, and its annual healthcare costs exceed $155 billion. People living with schizophrenia often experience a reduced quality of life (QOL) and are more likely to be homeless, unemployed, or living in poverty than the general population. Life expectancy for patients with schizophrenia is 15 to 20 years below the average. It is complicated by numerous comorbidities, such as weight gain, increased cardiovascular risk, and mood and cognition changes. Treatment nonadherence can increase the risk of relapse, rehospitalization, and self-harm, leading to a reduced QOL and increased economic burden.

    Schizophrenia is a complex chronic illness with multiple comorbidities and high mortality rates. The development of Long-Acting Injectables and generic medication options has significantly improved patient adherence and reduced care costs in patients with schizophrenia. Despite these advances, schizophrenia has a high economic burden for patients and society. Providers caring for patients with schizophrenia are charged with a complicated task of ensuring individualized care while managing numerous adverse effects that may occur with recommended therapy (Wander, 2020).

Wander, C. (2020).  Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Carehttps://www.ajmc.com/view/schizophrenia-opportunities-to-improve-outcomes-and-reduce-economic-burden-through-managed-care

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FDA Advisory Board In Favor of ALKS 3831 for Schizophrenia

October 9, 2020

Kenny Walter

Relevant Topics

The schizophrenia drug currently has a PDUFA date set for November 15.

    A US Food and Drug Administration’s (FDA) advisory committee has given a recommendation for the ultimate approval of a combination of olanzapine and samidorphan (ALKS 3831) in schizophrenia patients.

    During the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the group voted 16-1 to approve the treatment, developed by Alkermes.

    ALKS 3831 is an investigational, novel atypical antipsychotic earmarked for once-daily oral application for the 2 psychiatric disorders composed of samidorphan, a novel, new molecular entity, co-formulated with olanzapine, an established antipsychotic agent in a single bilayer tablet.

    Recently, researchers presented data from the ENLIGHTEN-2 trial, a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia.

    “The favorable outcome of today’s joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder,” Craig Hopkinson, MD, chief medical officer and executive vice president of R&D at Alkermes, said in a statement. The personal testimonies shared during today’s open public hearing reinforced the need for treatment approaches that consider patients’ overall mental and physical health. The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness.”

    There is currently a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15.

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Photo by Michael Jin & Photo by Camilo Jimenez on Unsplash

Recently, when we were still permitted to congregate socially, I was at a Friday night service in my synagogue when a young woman in the back row emitted a frightening scream, fell, and began convulsing. During her seizure, she hurt herself by falling and hitting her head (danger to self) and broke a chair nearby when she fell on it (property damage). Of course, paramedics were called who attended to her and eventually transported her to a hospital, whereupon I lost contact with this particular young woman and her continued treatment. At no point were the police involved with this manifestation of symptoms of an otherwise presumably well-controlled person with epilepsy. Being an emergency physician myself, I can only tell you that my experience with people with seizure disorders being brought to the emergency room is that they are never subsequently taken to jail.  The options are either hospitalization or, more frequently, discharged home on appropriate medications with appropriate follow up.

 

In another hypothetical scenario, a “brittle diabetic,” usually well-controlled on his insulin, passes out while driving and knocks over a Postal box when he runs into it with his car (a federal crime!).  Police and paramedics show up; the patient is taken to an emergency room where it is ascertained that he indeed has diabetes and had become hypoglycemic. The patient is either admitted to the hospital or sent home on appropriate medications with appropriate follow-up.

 

In neither of these cases detailed above, were the patients assumed to be criminals.  People exhibiting symptoms from a chronic disease are treated appropriately for their symptoms. Their underlying illness and hospitalization, if needed, are not a problem; there are plenty of inpatient beds for them.

 

Let’s contrast this with what might have happened if this was a person with serious mental illness attending the same Sabbath service and became symptomatic, started flailing around, and did some property damage as this woman did. Police and/or paramedics would have been called. The patient may or may not have been taken to an emergency room and may or may not have gone to jail because society draws a fine line (not so fine) between apparent “medical” conditions and “psychiatric” conditions. Unfortunately, in a behavioral health crisis, when people become symptomatic because of their underlying disease, the behaviors related to their disease can suddenly be considered a crime. Also, if it was adjudged that this patient needed further treatment on an inpatient basis, they would have found this to be nearly impossible as there is an extremely limited number of inpatient psychiatric beds in the state of Arizona.

 

Currently, experts recommend approximately one psychiatric inpatient bed for every 250,000 people. In Maricopa County alone, there are about 4 1/2 million people; this equates to an inpatient psychiatric capacity that should exist of around 1,800 inpatient beds. At present, in Maricopa County, there are just 55 beds available in the public system for long-term psychiatric treatment. The inadequate number of limited long-term inpatient psychiatric beds is a figure so egregiously deficient that the reader might well be shocked that this is the truth; shamefully, it is.

 

We need to correct this appalling lack of inpatient psychiatric therapy currently available for the Seriously Mentally Ill.

Charles Goldstein, MD

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August 19th, 2020 05:00 PM Arizona Come learn from respected psychiatrists- Dr. Beth Darling and Dr. Alicia L Cowdrey

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