The US Food and Drug Administration (FDA) has approved Alkermes PLC's schizophrenia treatment clearing the way for the Dublin-based biopharmaceutical company to start selling the drug.

Aristada, or aripiprazole lauroxil, will be available as a once-monthly and six-week injection, is a generic version of Abilify.

Aristada's features, including a range of dosing interval options and dose strengths, are designed to address the individual needs of patients and challenges in the treatment of schizophrenia.

Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time and assist healthcare providers to track patient adherence.

The FDA approval of Aristada was based on a proven safety and efficacy profile, including data from a randomized, double-blind, placebo-controlled, phase 3 study in 623 patients with schizophrenia.

The data from that trial demonstrated that multiple dose strengths of Aristada met the primary endpoint with significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, met the key secondary endpoint and showed significant improvements in schizophrenia symptoms versus placebo.

Schizophrenia is a chronic disabling brain disorder. The disease is marked by positive symptoms (delusions and hallucinations) and negative symptoms (depression and blunted emotions), as well as by disorganized thinking.

However, 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.

Cerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with aripiprazole, risperidone and olanzapine. Aristada is not approved for the treatment of patients with dementia-related psychosis.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop after relatively brief treatment periods at low doses. Discontinue Aristada if clinically appropriate.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as NMS might occur with administration of antipsychotic drugs, including ARISTADA. Clinical manifestations of NMS include altered mental status, hyperpyrexia, muscle rigidity, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Discontinue antipsychotic drugs and other drugs not essential to concurrent therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported. Patients with a history of significant low white blood cell count (WBC)/absolute neutrophil count (ANC) and history of drug-induced leukopenia/neutropenia should have frequent complete blood count (CBC) during the first few months of receiving Aristada.

Potential for Cognitive and Motor Impairment: Aristada might impair motor skills, judgment or thinking. Patients should be warned about operating hazardous machinery, including automobiles, until they are certain Aristada does not affect them adversely.

Seizures: Aristada should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration have been linked with antipsychotic drug use, use caution in patients at risk for aspiration pneumonia.

Concomitant Medication: Decrease the Aristada dosage in patients taking strong CYP3A4 inhibitors and/or strong CYP2D6 inhibitors for longer than two weeks. Increase Aristada dosage in patients taking CYP3A4 inducers for longer than two weeks. No Aristada dosage changes are recommended for patients taking CYP450 modulators for less than two weeks.

Injection-Site Reactions: Injection-site reactions were reported by 4, 5 and 2 percent of patients treated with 441 mg Aristada, 882 mg Aristada, and placebo, respectively.

Pregnancy/Nursing: Might cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Aristada during pregnancy.

Alkermes will host a conference call on Tuesday, Oct. 6, 2015, at 7:30 a.m. EDT (12:30 p.m. BST). The conference call will be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. The conference call will also be webcast on the Investors section of Alkermes' website at www.alkermes.com.

The results of the phase 3 study were published in June 2015 by The Journal of Clinical Psychiatry, a peer-reviewed medical journal.