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FDA approves long-acting injectable as treatment for bipolar disorder

FDA approves long-acting injectable as treatment for bipolar disorder

The Food and Drug Administration (FDA) has approved the extended-release formulation of aripiprazole (Abilify Maintena) as an injectable suspension for maintenance monotherapy treatment of bipolar 1 disorder (BP-1) in adults. Abilify Maintena is an atypical antipsychotic, developed jointly by Otsuka Pharmaceutical Co, Ltd, in Japan and H. Lundbeck A/S, a Danish international pharmaceutical company. It is an injectable formulation for intramuscular use once a month.

Mental health experts are of the opinion that the new formulation would definitely help in managing bipolar in a different and improved way. “Abilify Maintena provides healthcare professionals a new treatment option for their patients who have established tolerability with oral aripiprazole,” Joseph Calabrese, M.D., director of Mood Disorders Program, University Hospitals Cleveland Medical Center, and a professor of psychiatry at Case Western Reserve University School of Medicine, Cleveland, Ohio, told the media.

“Receiving Abilify Maintena each month as prescribed and administered by a healthcare professional provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder.” He further pressed for accompanying oral antipsychotic medication for 14 days after the first injection.

Findings prove Abilify Maintena is beneficial

The clinical trial that came out with the findings was a 52-week double blind, placebo controlled, randomized withdrawal study among adults with BP-1 who belonged to the age group of 18-65 years. The patients had at least one previous episode of manic or mixed symptoms and severe manic symptoms that required hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent. The patients were stabilized with Abilify Maintena prior to randomization.

BP-1, a chronic mental illness, has a 12-month prevalence of 1.5 percent and the lifetime prevalence of 2.1 percent, as per information provided by the company. Patients with BP-1 suffer one or more episodes of mania and might have episodes of both mania and depression.

The findings of the study revealed that the drug had demonstrated the capacity to delay the time of recurrence of any mood episode during a 52-week treatment period compared with placebo. The researchers witnessed significant differences between treatment groups in delaying the time of recurrence of both manic and mixed episodes. However, they did not see any major difference in depressive mood episodes.

Drug is not free of adverse effects

The drug, however, is not completely safe as it has few side effects as well. Abilify Maintena was approved in the United States in 2013 as a treatment for schizophrenia in adults. Some of its negative effects are weight gain, akathisia, injection site pain and sedation.

In addition to this, Abilify Maintena is not suitable for treatment of patients suffering from dementia-related psychosis. Contraindicated patients have hypersensitivity reactions to aripiprazole. The press release further warned that Abilify Maintena may cause orthostatic hypotension and hence, extreme caution should be exercised while administering the drug to patients with cardiovascular disease, cerebrovascular disease, or conditions that would predispose them to hypotension.

Dealing with mental health conditions

It is never easy living with mental problems, especially with more debilitating disorders like bipolar disorder. However, with timely treatment in credible rehab centers, one can significantly manage symptoms and lead a normal healthy life. One must not delay treatment or things can spiral out of hand.

Sovereign Health is a premier behavioral health treatment caregiver in the U.S. with its facilities in all major places in the country. If you are looking for treatment centers for bipolar disorder or any other mental condition, get in touch with our treatment advisors by contacting us at our 24/7 helpline number or chat online for a quick resolution. Our bipolar disorder residential treatment is among the best in the country.

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