Is brexpiprazole approved by FDA?

Is brexpiprazole approved by FDA?

Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved REXULTI® (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia.

When was brexpiprazole FDA approved?

Approval Date: July 10, 2015.

Does Rexulti have a black box warning?

Because Abilify and Rexulti are similar, they have the same warnings: There is a black box warning, which is the strongest warning required by the FDA. Abilify and Rexulti are not approved to treat elderly patients with dementia-related psychosis. These patients are at an increased risk of death.

What is the difference between aripiprazole and brexpiprazole?

One additional difference between brexpiprazole and aripiprazole is that antihistamine properties (binding at the H1 receptor) is reduced for brexpiprazole compared to aripiprazole (arrow of H1 binding moving to the right for brexpiprazole in Figure 7).

Is Rexulti approved for depression?

A new drug to treat schizophrenia and depression has been approved by the U.S. Food and Drug Administration. Rexulti (brexpiprazole) tablets can be used to treat adults with schizophrenia. The new drug can also be used as an add-on therapy to antidepressant drugs for adults with major depression.

Is Rexulti used for sleep?

It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Brexpiprazole is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics.

How long does it take Rexulti to work for depression?

Rexulti (generic name: brexpiprazole) is an atypical antipsychotic used to treat adults with schizophrenia or depression. In Rexulti studies, some people started to see results 1 or 2 weeks after starting treatment, but the best results were seen at the end of 6 weeks.

Do people gain weight on Rexulti?

People who took Rexulti gained an average of 2.8 to 3.5 pounds (1.3 to 1.6 kilograms), depending on their dose of the drug. In comparison, people who took a placebo gained an average of 0.7 lb (0.3 kg). Also, in clinical studies of people with schizophrenia, 3% to 4% of people taking Rexulti had weight gain.

What are the side effects of brexpiprazole?

Brexpiprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache.
• constipation.
• heartburn.
• tiredness.
• uncontrollable shaking of a part of the body.
• dizziness, feeling unsteady, or having trouble keeping your balance.