What’s the Problem?
Rexulti, a new antipsychotic drug that Otsuka Pharmaceutical designed as a replacement for Abilify, may increase the risk for similar compulsive behaviors such as gambling, shopping, eating and having sex.
What is Rexulti?
Rexulti (generic: brexpiprazole) is an atypical antipsychotic drug approved for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) and for treatment of schizophrenia. Rexulti is manufactured by Otsuka America Pharmaceutical, Inc., and was approved by the U.S. Food & Drug Administration (FDA) in July 2015.
Abilify vs Rexulti
Abilify and Rexulti are both 2nd generation antipsychotics that belong to the D2 partial agonist class of medications. Both drugs are FDA-approved for the treatment of schizophrenia, and as an adjunct treatment to antidepressants for major depressive disorder (MDD).
Rexulti Side Effects
Serious side effects of Rexulti may include:
- Uncontrollable Compulsive Behaviors – Gambling, sex, shopping, eating.
- Extrapyramidal Effects – Acute dyskinesias and dystonic reactions, tardive dyskinesia, Parkinsonism, akinesia, akathisia, neuroleptic malignant syndrome.
- Suicidal Thoughts – Particularly in children, teenagers and young adults.
Common side effects:
- Weight gain
- Runny / stuffy nose
- Increased appetite
What is Pharma Evergreening?
Evergreening is a strategy by which pharmaceutical companies extend their patents over products that are about to expire, in order to retain royalties from them, by either taking out patents on new products that are essentially the same as existing ones, buying out patents, or frustrating competitors.
Critics have pointed to a case of evergreening with Abilify and Rexulti, which are both made by Otsuka America Pharmaceutical, Inc., and work basically the same, although each has a distinct pharmacological profile. Otsuka claims Rexulti is an improvement on Abilify, but this has yet to be proven.
What is Obsessive-Compulsive Disorder?
Obsessive-compulsive disorder (OCD) is an anxiety disorder characterized by uncontrollable, unwanted thoughts and repetitive, ritualized behaviors patients feel compelled to perform. Many patients with OCD are able to recognize that their obsessive thoughts and compulsive behaviors are irrational, but are unable to resist them or break free.
Symptoms of OCD
- Repeated unwanted ideas
- Aggressive impulses
- Persistent sexual thoughts
- Fear of contamination
- Images of hurting someone you love
- Thoughts that you might cause others harm
- Thoughts that you might be harmed
Feb 2011 – Current Drug Safety study published
February 1, 2011 – Study published in Current Drug Safety describes 3 cases of gambling addiction in patients treated with aripiprazole (active ingredient in Abilify).
July 2011 – British Journal of Psychiatry study published
July 2011 – Study published in the British Journal of Psychiatry reports on 3 schizophrenia patients who experienced compulsive gambling behaviors after taking aripiprazole.
Aug 2013 – Vanderbilt University study published
August 2013 – Study published by Vanderbilt University finds a 3-fold increased risk of type 2 diabetes in children who take aripiprazole for non-psychosis-related disorders.
Dec 2014 – JAMA Internal Medicine study listing
December 2014 – JAMA Internal Medicine study lists 37 cases of behavior disorders in patients who took aripiprazole.
May 2015 – Patent protection lost
May 2015 – Abilify loses patent protection.
Jul 2015 – Approved for schizophrenia treatment
July 10, 2015 – FDA approves Rexulti to treat schizophrenia and as an add-on for major depressive disorder (MDD).
- “Aripiprazole-induced pathological gambling: a report of 3 cases”. Current Drug Safety. February 1, 2011.
- “Pathological gambling and the treatment of psychosis with aripiprazole: case reports”. The British Journal of Psychiatry. July 2011.
- “Antipsychotic drug use in children for mood/behavior disorders increases type 2 diabetes risk”. Vanderbilt University. August 22, 2013.
- “Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs”. JAMA Internal Medicine. December 2014.
- “Bristol-Myers braces for Abilify patent loss, predicting big sales drop for 2015”. FiercePharma. January 27, 2015.
- “FDA approves new drug to treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder”. U.S. Food & Drug Administration (FDA). July 13, 2015.
- ”Rexulti vs Abilify – An Example of Pharma Evergreening?” Brain Pro Tips. November 30, 2015.