Alkermes has secured the US Food and Drug Administration (FDA) approval for its Aristada Initio (aripiprazole lauroxil) for the initiation of Aristada (aripiprazole lauroxil), an injectable atypical antipsychotic for the treatment of schizophrenia in adults.
Alkermes claims that Aristada Initio, in combination with a single 30 mg dose of oral aripiprazole can offer physicians with an alternative regimen to initiate patients into any dose of Aristada on day one.
For people with schizophrenia, medication compliance and continuity of care can be challenging and transitioning from inpatient care to outpatient settings can also be a vulnerable time.
Earlier, the standard initiation regimen for Aristada was 21 consecutive days of oral aripiprazole starting with the first Aristada dose.
The new Aristada Initio regiment offers patients with relevant levels of aripiprazole within four days of initiation. This results in an alternative initiation regiment that offers healthcare providers with an additional tool to support patients during the critical time in their treatment journey.
Alkermes stated that Aristada and Aristada Initio both contain aripiprazole lauroxil, but the two medications are not interchangeable because of the differing pharmacokinetic profiles.
Aristada Initio uses NanoCrystal technology designed to provide an extended-release formulation using a smaller particle size of aripiprazole lauroxil in comparison to Aristada. It speeds up the dissolution, leading to more rapid achievement of relevant levels of aripiprazole.
Alkermes chief medical officer and medicines development and medical affairs senior vice president Craig Hopkinson said: “Long-acting injectable atypical antipsychotics have an increasingly recognized role in the treatment of schizophrenia. 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.
“The approval of Aristada Initio adds an important new option to our growing schizophrenia portfolio and reaffirms Alkermes’ commitment to developing innovative treatments that address the real-world needs of people living with schizophrenia.”