FDA approves Aristada Initio for schizophrenia

 

The Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio) for the initiation of aripiprazole lauroxil (Aristada) for treating schizophrenia in adults, the drug’s developer, Alkermes, announced July 2 in a press release.

The alternative formulation of the long-acting injectable is intended be used with a single 30-mg dose of oral aripiprazole and can be initiated on the first day of treatment, Alkermes stated.

“The ability to initiate Aristada on day one may be particularly useful in the hospital setting, where more than one-third of patients initiate onto long-acting therapies,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in the press release.

The standard initiation regimen for aripiprazole lauroxil previously was 21 consecutive days of oral aripiprazole starting with the first dose of Aristada. The alternative initiation regimen allows patients to achieve “relevant levels of aripiprazole within 4 days of initiation,” according to Alkermes. The result gives health care providers “an additional tool to support patients.”

One important advantage of Aristada Initio is that, in addition to monthly and 6-week dosing options, it offers a 2-month option.

Aristada and Aristada Initio both contain aripiprazole lauroxil, but the drugs are not interchangeable because they have different pharmacokinetic profiles, the company said. In addition, Aristada Initio is to be administered a single time only.

Aristada Initio has exhibited some of the same adverse events as other atypical antipsychotics, including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Injection-site reactions also have been observed.

Aristada Initio is expected to become available by mid-July.

Full prescribing information and boxed warnings can be found on the Alkermes website.

[email protected]

 

The Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio) for the initiation of aripiprazole lauroxil (Aristada) for treating schizophrenia in adults, the drug’s developer, Alkermes, announced July 2 in a press release.

The alternative formulation of the long-acting injectable is intended be used with a single 30-mg dose of oral aripiprazole and can be initiated on the first day of treatment, Alkermes stated.

“The ability to initiate Aristada on day one may be particularly useful in the hospital setting, where more than one-third of patients initiate onto long-acting therapies,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in the press release.

The standard initiation regimen for aripiprazole lauroxil previously was 21 consecutive days of oral aripiprazole starting with the first dose of Aristada. The alternative initiation regimen allows patients to achieve “relevant levels of aripiprazole within 4 days of initiation,” according to Alkermes. The result gives health care providers “an additional tool to support patients.”

One important advantage of Aristada Initio is that, in addition to monthly and 6-week dosing options, it offers a 2-month option.

Aristada and Aristada Initio both contain aripiprazole lauroxil, but the drugs are not interchangeable because they have different pharmacokinetic profiles, the company said. In addition, Aristada Initio is to be administered a single time only.

Aristada Initio has exhibited some of the same adverse events as other atypical antipsychotics, including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Injection-site reactions also have been observed.

Aristada Initio is expected to become available by mid-July.

Full prescribing information and boxed warnings can be found on the Alkermes website.

[email protected]

 

The Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio) for the initiation of aripiprazole lauroxil (Aristada) for treating schizophrenia in adults, the drug’s developer, Alkermes, announced July 2 in a press release.

The alternative formulation of the long-acting injectable is intended be used with a single 30-mg dose of oral aripiprazole and can be initiated on the first day of treatment, Alkermes stated.

“The ability to initiate Aristada on day one may be particularly useful in the hospital setting, where more than one-third of patients initiate onto long-acting therapies,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in the press release.

The standard initiation regimen for aripiprazole lauroxil previously was 21 consecutive days of oral aripiprazole starting with the first dose of Aristada. The alternative initiation regimen allows patients to achieve “relevant levels of aripiprazole within 4 days of initiation,” according to Alkermes. The result gives health care providers “an additional tool to support patients.”

One important advantage of Aristada Initio is that, in addition to monthly and 6-week dosing options, it offers a 2-month option.

Aristada and Aristada Initio both contain aripiprazole lauroxil, but the drugs are not interchangeable because they have different pharmacokinetic profiles, the company said. In addition, Aristada Initio is to be administered a single time only.

Aristada Initio has exhibited some of the same adverse events as other atypical antipsychotics, including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Injection-site reactions also have been observed.

Aristada Initio is expected to become available by mid-July.

Full prescribing information and boxed warnings can be found on the Alkermes website.

[email protected]