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Health & Fit New Schizophrenia Drug Approved by FDA, Will Be Available as Transdermal Patch

02:40  16 october  2019
02:40  16 october  2019 Source:   newsweek.com

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The first transdermal patch used to treat schizophrenia has been approved by the U.S. Food and Drug Administration.

a group of different colors: Schizophrenia affects more than 21 million people worldwide, according to the World Health Organization.© Getty Schizophrenia affects more than 21 million people worldwide, according to the World Health Organization.

The medication, asenapine, manufactured by Noven Pharmaceuticals, will be marketed under the brand name Secuado.

Secuado gives a once-a-day sustained dose of the anti-psychotic drug many people suffering from schizophrenia rely on. Asenapine treats schizophrenia by rebalancing chemicals, such as dopamine and serotonin, in the brain, and transdermal delivery may offer patients an easy way to take their medication.

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The once-daily transdermal drug delivery system (TDDS) provides sustained concentrations during wear time (24 hours)2 of the atypical antipsychotic drug asenapine, a well-established treatment for schizophrenia . A transdermal patch may help to mitigate some of the challenges patients face with

Transdermal drug products are administered to the skin, through which the drugs permeate into the systemic circulation and are delivered throughout the body to the site of action. Transdermal products are most frequently developed as transdermal delivery systems (TDS), also known as patches .

"In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized," said Leslie Citrome, clinical professor of Psychiatry and Behavioral Sciences at New York Medical College, in a statement.

Globally, schizophrenia affects more than 21 million people, according to the World Health Organization. The disorder distorts thinking, perception and one's sense of self. Both visual and aural hallucinations are common symptoms of schizophrenia, as is delusional thinking.

While schizophrenia is more common among males than females, males are more likely to show signs of the disorder early. Schizophrenics are also two to three times more likely to die early from preventable physical illnesses, such as cardiovascular disease.

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An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug . The ANDA is submitted to FDA 's Center for Drug Evaluation and Research, Office of Generic Drugs

Like any medication, Secuado has side effects, including tardive dyskinesia, a condition that causes uncontrolled body movements, especially in the face. Those taking the drug could also suffer blood pressure drops or spikes. It cannot be used to treat dementia-related psychosis.

Anti-psychotic medications are big business, with the global market size valued at $14.9 billion in 2018, according to Fortune Business Insights.

Stocks for Noven were up Tuesday morning on news of the approval. The release date for the medication is not yet clear.


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