Aripiprazole lauroxil, developed by Alkermes, is an extended-release injectable formulation of aripiprazole used for the treatment of schizophrenia and bipolar I disorder [1]. It is administered intramuscularly and is designed to provide consistent drug levels over several weeks [1][2].
How does aripiprazole lauroxil work?
Aripiprazole lauroxil is a prodrug that is converted to aripiprazole in the body [1]. Aripiprazole is an atypical antipsychotic that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptors [1][3]. This mechanism is believed to help regulate dopamine and serotonin activity, which are implicated in mood and thought disorders [3].
What is the difference between aripiprazole lauroxil and oral aripiprazole?
The primary difference lies in their administration and pharmacokinetic profiles. Oral aripiprazole requires daily dosing, whereas aripiprazole lauroxil is an intramuscular injection administered monthly or every two weeks, depending on the formulation [1][2]. This extended-release formulation can improve adherence for patients who struggle with daily medication regimens [1].
When did Alkermes launch aripiprazole lauroxil?
Alkermes launched aripiprazole lauroxil under the brand name Aristada in July 2015 [4].
Are there different versions of Aristada?
Yes, Alkermes offers multiple formulations of Aristada. These include Aristada given every two weeks and Aristada given monthly. There is also Aristada Initio, which is a short-acting injection used to start treatment and achieve therapeutic aripiprazole levels quickly before transitioning to a longer-acting formulation [2][5].
What are the expected side effects of aripiprazole lauroxil?
Common side effects reported with aripiprazole lauroxil include insomnia, headache, and injection site pain [1]. More serious potential side effects can include movement disorders (extrapyramidal symptoms), tardive dyskinesia, metabolic changes (such as hyperglycemia and dyslipidemia), and neuroleptic malignant syndrome [1][3].
What are the patent and exclusivity timelines for Aristada?
Information regarding the specific patent and exclusivity expiry dates for Aristada is available through resources like DrugPatentWatch.com [6]. Patents and regulatory exclusivities play a crucial role in determining when generic or biosimilar versions of a drug can enter the market [7].
Who are the competitors to aripiprazole lauroxil?
Other extended-release injectable antipsychotics are available, including those from other manufacturers for schizophrenia and bipolar disorder [8]. These competitors may offer different dosing schedules, mechanisms of action, or side effect profiles, influencing treatment choices for clinicians and patients [3][8].
Sources:
[1] https://www.drugpatentwatch.com/drugs/aripiprazole-lauroxil
[2] https://www.drugpatentwatch.com/branded-drugs/aristada-initio
[3] https://www.drugpatentwatch.com/drugs/aripiprazole
[4] https://www.drugpatentwatch.com/companies/alkermes
[5] https://www.drugpatentwatch.com/branded-drugs/aristada
[6] https://www.drugpatentwatch.com/patents/aristada
[7] https://www.drugpatentwatch.com/exclusivities
[8] https://www.drugpatentwatch.com/drug-categories/atypical-antipsychotics