General
publicado em 02/03/2013 às 17h00:00
   Dê o seu voto:

FDA approves monthly injectable treatment for schizophrenia

Abilify new formulation is intended to provide relapse prevention of symptoms of long-term condition, say researchers

 
font size
A-
A+

Regulators on Thursday approved a once-monthly injectable form of Abilify, the blockbuster treatment for schizophrenia, which will be sold by Japanese drugmaker Otsuka and Danish drug group Lundbeck.

In July 2012, the Food and Drug Administration declined to approve the medicine, Abilify Maintena, citing deficiencies from an inspection of a third-party supplier of sterile water. Otsuka and Lundbeck resubmitted their marketing application soon afterward, after working with an alternative supplier.

About 1 percent of adults in the United States are believed to have schizophrenia, a disorder of thought processes that can involve hallucinations, delusions and poor emotional responsiveness.

The new formulation of Abilify is meant to provide long-term prevention of relapses from schizophrenia symptoms, particularly for patients who don't faithfully take their anti-psychosis medicines.

But the medicine has a convenience disadvantage. It comes in a "cake" form, which must be diluted with sterile water for injection. That means it has to be given by a healthcare professional.

For a decade, Otsuka and Bristol-Myers Squibb had co-marketed the once-daily basic formulation of Abilify, which had global sales of $2.8 billion in 2012. Under an updated partnership agreement, Otsuka early this year began to take on complete marketing responsibility for basic Abilify, but Bristol-Myers will continue to manufacture the medicine and share in revenue from it.

Source: Isaude.net
  • Share this pageShare this page
  • Share this pageCorrect
  • ShareShare
  • AlertAlert
Reduced link: 
  • You are recommending this story: FDA approves monthly injectable treatment for schizophrenia
  • Fill in the following form to send your recommendation to your friend:

  • You are suggesting a correction for this story: FDA approves monthly injectable treatment for schizophrenia


Receba notícias do iSaúde no seu e-mail de acordo com os assuntos de seu interesse.
Seu nome:
Seu email:
Desejo receber um alerta com estes assuntos:
Schizophrenia    Abilify    Abilify Maintena    monthly injectable treatment    Food and Drug Administration   
Comments:
Comment
Leave your comment
Close
(Required fields are marked with an *)

(Your email address will never be published or shared.)

Enter the letters and numbers below and click in the button "send"

  • Twitter iSaúde
advertising
Informe Saúde printed version

Recommend the portal
Close [X]
  • You are recommending this story: http://www.isaude.net
  • Fill in the following form to send your recommendation to your friend:

RSS news from the portal  iSaúde.net
Get the newsletter of the portal  iSaúde.net
Recommend the portal iSaúde.net
News from  iSaúde.net in your blog or website.
Get news on the subject of your interest.
© 2000-2011 www.isaude.net Todos os direitos reservados.