Irish biopharmaceutical company Alkermes has received approval from the US Food and Drug Administration (FDA) for the use of its Aristada Initio to initiate Aristada as a treatment for adults with schizophrenia.
Aristada is a long-acting injectable atypical antipsychotic indicated in four doses and three dosing durations of 441mg, 662mg or 882mg monthly, 882mg once every six weeks and 1064mg once in two months.
The combination of Aristada Initio and a single 30mg dose of oral aripiprazole can now be used to initiate onto any dose of Aristada, the first dose of which can be given on the same day or up to ten subsequent days.
The regimen with the newly approved product is expected to provide relevant aripiprazole levels within four days of initiation, thereby offering an alternative regimen to support schizophrenia patients.
While both Aristada and Aristada Initio are made of aripiprazole lauroxil, they have different pharmacokinetic profiles.
Aristada Initio uses Alkermes’ NanoCrystal technology and is intended to deliver an extended-release formulation while using a smaller particle size of aripiprazole lauroxil than that of Aristada. This is said to allow faster dissolution and rapid achievement of relevant aripiprazole levels.
Alkermes chief medical officer and Medicines Development and Medical Affairs senior vice-president Craig Hopkinson said: “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.”
Alkermes is planning to make Aristada Initio commercially available by the mid of this month.