Aristada (aripiprazole lauroxil) extended-release injectable

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2015

Specific Treatments:

schizophrenia

Therapeutic Areas

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General Information

Aristada (aripiprazole lauroxil) is an atypical antipsychotic.

Aristada is specifically indicated for the treatment of schizophrenia.

Aristada is supplied as a solution for intramuscular administration. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Depending on individual patient’s needs, treatment with Aristada can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, which corresponds to 300 mg, 450 mg and 600 mg of aripiprazole, respectively. Treatment may also be initiated with the 882 mg dose every 6 weeks. Administer Aristada either in the deltoid muscle (441 mg dose only) or gluteal muscle (441 mg, 662 mg or 882 mg). 

 

Clinical Results

FDA Approval

The FDA approval of Aristada was based, in part, on the basis of efficacy data from trials with the oral formulation of aripiprazole. In addition, the efficacy of Aristada was established in a 12-week, randomized, double-blind, placebo-controlled, fixed-dose study in adult patients with schizophrenia meeting DSM-IV TR criteria [Study 1, n = 622; 207 (Aristada 441 mg), 208 (Aristada 882 mg), and 207 (placebo)]. After establishing tolerability to oral aripiprazole, patients received oral aripiprazole or placebo daily for the first 3 weeks. The intramuscular (IM) injections were administered on Days 1, 29 and 57. Efficacy was assessed using Positive and Negative Syndrome Scale (PANSS), the primary endpoint, and Clinical Global Impression Improvement Scale (CGI-I), the secondary endpoint.  Statistically significant separation from placebo on PANSS total score change was observed in each Aristada dose group. The secondary efficacy endpoint was defined as the CGI-I score at Day 85. Both Aristada treatment groups demonstrated statistically significantly better CGI-I scores versus placebo.

Side Effects

The most common adverse event associated with the use of Aristada was akathisia.

Aristada comes with a black box warning of increased mortality in elderly patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aristada is not approved for the treatment of patients with dementia-related psychosis

Mechanism of Action

Aristada (aripiprazole lauroxil) is an atypical antipsychotic. Following intramuscular injection, Aristada is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. The mechanism of action of aripiprazole in the body is unknown. However, efficacy could be mediated through a combination of partial agonist activity D2 and 5­ HT1A receptors and antagonist activity at 5-HT2A receptors.

Additional Information

For additional information regarding the use of Aristada or schizophrenia, please visit http://www.alkermes.com/