Despite demonstrated dangers and side effects, which are the primary cause of action in the dozens of lawsuits currently part of a mass tort action, the atypical antipsychotic medication Abilify remains on pharmacy shelves. It continues to be taken by patients and shockingly, is forced on juvenile inmates by state correctional authorities, who use it as a type of “chemical restraint.” Until it lost its patent in October of 2014, Abilify (aripiprazole) was a major seller for Otsuka Pharmaceuticals and its U.S.-based partner, Bristol-Meyer Squibb, bringing in nearly $7 billion in its last eighteen months of exclusivity.
Six months later, a new medication from Otsuka, known as brexpiprazole, won FDA approval and is currently sold under the brand name Rexulti. One will note that like its predecessor, the name of the new product contains the element “piprazole.” Rexulti, like Abilify, is an atypical antipsychotic used to treat schizophrenia and as an adjunct treatment for serious depression. Both of these medications have similar profiles, or characteristics. These include dosage, indications and contraindications as well as mechanism of action (both drugs act upon a specific dopamine receptor).
They also have similar side effects. Otsuka recently updated its package label, warning consumers that taking Rexulti may cause them to engage in compulsive, uncontrollable behaviors, including gambling, shopping, and sex. Other side effects include weight gain, anxiety and restlessness, sinus problems such as rhinorrhea (runny or stuffy nose), headaches and dizziness.
In general, it appears that the “new” medication is neither all that different, nor better, than the old one. It may in fact be another example of what is known in the pharmaceutical industry as “evergreening.”
The term “evergreening” refers to any number of strategies employed by manufacturers that are used to extend patents and exclusivity over products for which said patents are reaching expiration. This allows them to continue to sidestep regulations and continue to collect royalties while discouraging competition from generic versions for longer periods than are normally allowed by statute.
Legally, this is a gray area. In 2002, the Federal Trade Commission (FTC) examined provisions of 1984 Drug Price Competition and Patent Term Restoration Act, better known as Hatch-Waxman. The intent behind the law, which has been revised several times over the years, was to make it easier for generic drugmakers to get FDA approval by filing an Abbreviated New Drug Application (ANDA) by streamlining the process and prevent the original manufacturers from putting roadblocks in their way.
Following its investigation of Hatch-Waxman, the FTC recommended that only a single injunction against evergreening be allowed for a new generic product, and created a faster, more efficient process for the resolution of an evergreening claim.
In 2015, it was noted that Rexulti, being a much newer drug than Abilify (which was approved in 2002), could have risks and side effects that had not yet been identified in post-marketing studies. Those risks and side effects have now become apparent, as Otsuka has issued a new warning for its product. The primary question now is: was the company aware of these risks when they filed for FDA approval?
It remains to be seen whether or not Otsuka will find itself targeted in a new round of lawsuits as injured patients come forward.