FDA approves new injectable drug NCE to treat schizophrenia (aripiprazole lauroxil)

Publicado por en 9 Oct, 2015 en Noticias | Sin comentarios

The Food and Drug Administration on Monday approved Alkermes PLC’s schizophrenia treatment clearing the way for the Dublin-based biopharmaceutical company to start selling the drug.

Aristada, or aripiprazole lauroxil, will be available as a once-monthly and six-week injection. It is a new chemical entity that, once injected into the body, undergoes steps to yield aripiprazole, whose trade name is Abilify.

In April, the FDA approved four generics of Otsuka Pharmaceutical Co.’s best-selling drug Abilify by Alembic Pharmaceuticals Ltd. , Hetero Labs Ltd., Teva Pharmaceuticals Industries Ltd. and Torrent Pharmaceuticals Ltd.

In 2014, the last full year in which Bristol-Myers Squibb Co. had exclusive rights to sell Abilify in the U.S., it reported $2.02 billion in sales of the drug. Bristol-Myers’ exclusive rights ended in April along with Otsuka’s Abilify market exclusivity.

Schizophrenia is a chronic, disabling brain disorder that affects about 1% of the U.S. population, according to the National Institute of Mental Health.

Aristada is not approved to treat patients with dementia-related psychosis. The most common adverse reactions in a clinical trial were insomnia, headaches and akathisia, a form of inner restlessness.

The efficacy of Aristada was demonstrated in part by a 12-week clinical trial in 622 participants. In participants with acute schizophrenia who had been stabilized with oral aripiprazole, Aristada was found to maintain the treatment effect compared to a placebo.

Aristada and other atypical antipsychotic drugs used to treat schizophrenia have a Boxed Warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis. Aristada must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

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