Rexulti, an oral medication prescribed for major depressive disorder (MDD) and schizophrenia, is an atypical antipsychotic [1]. It is approved for use in adults in combination with an antidepressant to treat MDD and as a standalone treatment for schizophrenia [1][2].
How does Rexulti work for depression?
Rexulti functions as a partial agonist at dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptors [1][3]. This dual mechanism is thought to help regulate dopamine and serotonin pathways in the brain, which are implicated in mood disorders [3]. It is not a cure for depression but helps manage symptoms [4].
What is the active ingredient in Rexulti?
The active ingredient in Rexulti is brexpiprazole [1].
When does Rexulti's patent expire?
Patent expiration dates for medications can be complex, involving multiple patents covering the drug substance, formulations, and methods of use. According to DrugPatentWatch.com, the original U.S. patent for Rexulti's active ingredient, brexpiprazole, has expired [5]. However, additional patents and exclusivities may remain in force, potentially affecting the timeline for generic competition.
Who makes Rexulti?
Rexulti is manufactured by Otsuka Pharmaceutical [1].
How does Rexulti compare to other antidepressants?
Rexulti is used as an add-on treatment to standard antidepressant therapy for MDD, rather than a primary treatment [1]. It works differently from selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) by modulating dopamine and serotonin activity in a unique way [3]. Its efficacy and side effect profile are distinct from other antidepressants and antipsychotics used as augmentation agents [1][4].
What are the common side effects of Rexulti?
Common side effects reported in clinical trials include weight gain, somnolence, headache, and akathisia (a feeling of inner restlessness) [1]. Patients should discuss potential side effects with their healthcare provider [4].
Can Rexulti be used for other conditions?
While approved for MDD and schizophrenia, brexpiprazole's pharmacological profile suggests potential investigation for other central nervous system disorders, though it is not currently approved for these uses [1][3].
What is the typical dosage of Rexulti?
Dosage varies depending on the condition being treated and patient response. Dosing information is provided by the prescribing physician [1][2].
What are the risks associated with Rexulti?
Like other atypical antipsychotics, Rexulti carries a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis [1]. Other potential risks include tardive dyskinesia, metabolic changes (such as hyperglycemia), orthostatic hypotension, leukopenia, and potential for impulse control issues [1][4].
What happens if I miss a dose of Rexulti?
Patients should follow their doctor's instructions regarding missed doses. Generally, it is advised to take the missed dose as soon as remembered, unless it is close to the time for the next dose, in which case the missed dose should be skipped [4].
Are there alternative treatments for MDD augmentation?
Yes, other atypical antipsychotics such as aripiprazole and quetiapine are also approved for use as adjunctive treatments for MDD [4].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfdadocs/label/2015/206141s000lbl.pdf
[2] https://www.accessdata.fda.gov/drugsatfdadocs/label/2022/206141s018lbl.pdf
[3] https://www.drugbank.ca/drugs/DB08879
[4] https://www.webmd.com/drugs/2/201800/rexulti-oral
[5] https://drugpatentwatch.com/