Rexulti is an anti-psychotic medication that is intended to treat disorders such as schizophrenia and depression. Rexulti is FDA-approved for treatment for Major Depressive disorder (MDD) and Schizophrenia. It is the successor to the highly commercially successful drug Abilify. Like Abilify, Rexulti has side effects that can have devastating consequences. Specifically, some who have taken the drug have experienced bouts of compulsive gambling that have caused them severe financial distress. Other addictive behavior has resulted from Rexulti as well. Lawyers are investigating the possibility of lawsuits against the manufacturer Otsuka Pharmaceuticals for the harm caused by these side effects. If you or a loved one has taken Rexulti and suffered from compulsive behavior, including gambling, you should immediately contact a Rexulti lawsuit lawyer to discuss your case. Coming forward in the investigatory phase increases the chances that successful lawsuits may be filed against the maker of this drug.
***WE are no longer accepting these cases***
What is Rexulti?
Rexulti followed the drug Abilify, which reaped huge profits for its manufacturer Otsuka Pharmaceuticals. Abilify is a primary treatment for schizophrenia and bipolar disorder. After it was introduced, there was a study that showed that, when combined with another antidepressant, Abilify could be used to treat major depressive disorder. Abilify is an atypical antipsychotic, meaning that it is supposed to have fewer side effects than the traditional antipsychotic medication. The drug can also treat the manic phases of bipolar disorder in conjunction with other mood stabilizer.
Best selling drugs of all time
Abilify became one of the best selling drugs of all time. In a 12-month period from 2013 to 2014, the drug had approximately $7.5 billion in sales. This resulted from several factors. The first was its popularity and the second was the fact that a 30-day supply of the drug cost nearly $800. Abilify’s patent expired in 2014 and the drug faced the prospect of competition from cheaper generic alternatives. Before the patent expired, Otsuka introduced Rexulti to the market. The drug was approved by the FDA for use in patients over the age of 18 in 2015. The drug is sold in partnership with the Dutch company Lundbeck. The Dutch company gave Otuska an upfront payment as well as future payments in exchange for a share of the revenues of the drug.
Update-2/18/19- “Lundbeck has announced that Rexulti (brexpiprazole) failed to achieve the primary endpoint of two Phase III studies of patients with manic episodes associated with bipolar I disorder. The Danish drugmaker, along with Otsuka who discovered the drug, announced that in both trials the therapy failed to achieve separation from placebo regarding improvements of psychiatric signs and symptoms. The efficacy of Rexulti for the acute treatment of manic episodes, with or without mixed features, in subjects with bipolar I disorder was investigated in two three-week, double-blind, placebo-controlled trials in 650 bipolar I patients. The main goal of each trial was to show that the drug induced a statistically significant improvement on a common rating scale used to assess mania symptoms based on a patient’s subjective reports and clinician observations.” Pharma Times
7-11-2015- “H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US 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. Rexulti was discovered by Otsuka and co-developed with Lundbeck. It will be co-marketed by the two companies and is expected to become available to patients in the US in early August 2015….Rexulti was studied in more than 4,300 subjects in phase II and III clinical trials, and the approval was supported by four completed placebo-controlled clinical phase III studies in the now-approved indications – two studies as adjunctive therapy to antidepressants in MDD and two studies in schizophrenia.” Global News Wire
Newer version of Abilify with fewer side effects
The drug was intended to be a newer version of Abilify with fewer side effects. The mechanism of treatment is the same. Rexulti is even more expensive than Abilify, costing over $1200 for a 30-day supply. In Fiscal year 2017, Rexulti’s sales reached nearly half a billion dollars. Since then, sales of the drug have increased at a rapid clip. Even the manufacturer cannot exactly describe how Rexulti works as a treatment for depression. A direct quote on the drug’s website states “While the exact way REXULTI works is unknown, scientists believe that it has a similar range of activity at 3 types of neurotransmitter receptors.” Loosely stated, Rexulti rebalances serotonin and dopamine to improve thinking and mood. However, simply stating that it acts on the serotonin does not give an in-depth mechanism of its mechanism. It is certain that Rexulti is a partial agonist, meaning that it stimulates some functions and blocks others at the receptors to which it binds.
Speaking casually, the medication is believed to work although nobody is quite sure why. The FDA approved these medications for treatment of depression so it apparently agrees. Nevertheless, Otsuka aggressively markets both Abilify and Rexulti and instrumental in the treatment of depression. Physicians apparently are responsive to the marketing because they continue to prescribe these drugs at high rates.
What are the Side Effects of Rexulti?
As stated above, Rexulti is designed to have fewer side effects than Abilify. The common side effects of Rexulti are weight gain, agitation and distress. Some of the more serious side effects of Rexulti are stroke in elderly patients, high blood sugar and involuntary body movements. Relevant here is the potential for Rexulti to cause certain uncontrollable urges in patients. This can include urges to gamble, binge shop and eat and sexual urges. These problems were also caused by the predecessor drug Abilify. There were scores of stories of people with no prior history of gambling taking Abilify and then going on a financially ruinous gambling binge.
Excessive gambling
The reason why Rexulti can cause excessive gambling comes from what little is known about the science behind the drug. As described above, Rexulti attempts to balance dopamine and serotonin. This could mean that it may inhibit it or alternatively, it may increase the levels of these substances in the brain. It is when dopamine is excessively stimulated that it potentially can cause a problem for the patient. High levels of dopamine make a patient crave both the stimulation and the reward that goes along with it. When it comes to gambling, this is particularly dangerous.
It was not until 2016 that mentions of compulsive gambling were added to the warning label for Abilify. Otuska did not update the warning label for Rexulti until 2018, even though some of the same instances of compulsive gambling were being reported for it too, and the mechanism of the drug is similar to Abilify. The specific language on the warning label references “post-marketing case reports” providing an indication that patients can experience intense urges.
Lawsuits filed by Rexulti lawsuit lawyers Against Otsuka for Rexulti
Plaintiffs have had some success in filing lawsuits against Otsuka for the compulsive gambling side effects that resulted from the use of Abilify. There was a multi-district litigation which designated three bellweather cases to go to trial. Otsuka settled these three cases before the trial. However, the parties were not able to reach a global settlement for the subsequent cases so they are set to go to trial.
Rexulti has resulted in many of the same issues as Abilify.
Rexulti has resulted in many of the same issues as Abilify. One of the possible causes of action against Otsuka should the cases be filed is that Otsuka failed to warn those taking Rexulti of the side effect of compulsive gambling. Otsuka had indications for many years that there are possible problems with Abilify and the two drugs use largely the same mechanism. However, Otsuka sold Rexulti for nearly three years before it added warnings about urges and gambling to the drug’s label. Currently, these cases are in the investigatory phase, meaning attorneys are meeting with potential plaintiffs and are gathering facts. It is likely that plaintiffs and their attorneys are waiting to see how the Abilify cases fare when they go to trial before initiating large amounts of cases relating to Rexulti. If Otsuka loses the Abilify cases, they may be more likely to settle possible Rexulti cases.
What You Can Do If Affected by Rexulti
If you have had your life altered by any sort of compulsive urges after taking Rexulti, you may be entitled to financial compensation. Please note that this includes not only gambling, but any other kind of addictive behavior. You may even be able to bring a claim if you made a bad financial decision that caused harm to you. It is important that you seek out an attorney now to discuss the facts of your case. In the fact gathering stage, you are not obligated to pay the attorney anything. In fact, the Rexulti lawsuit attorney is not paid unless they are able to help you to obtain a financial recovery. It is vital that you contact the Rexulti lawsuit attorney soon in order to file any possible case before the statute of limitations expires.
Sources: