Alkermes Scores FDA Approval for Potential Game-Changing Schizophrenia Treatment

FDA Approval

Shares of Alkermes plc are climbing in premarket trading after the company announced the U.S. Food and Drug Administration (FDA) approved Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.

The approval marks a significant shift in the treatment of patients with schizophrenia. The approval of Aristada Initio gives doctors the ability to initiate treatment of Aristada, the only long-acting injectable long-acting injectable atypical antipsychotic, on the first day. Typically, treatment with long-acting injectables for schizophrenia requires supplementation over the course of several weeks to help patients achieve relevant therapeutic levels of medication in their system. Before the approval of Aristada Initio, patients who were to be given Aristada, had to undergo three weeks of oral aripiprazole following the first injection. Alkermes said the approval of Aristada Initio, which is prescribed in combination with a single 30 mg dose of oral aripiprazole, will make it possible for patients to begin taking Aristada on day one of treatment. Alkermes anticipates the new injectable will be available for patients in the middle of this month.

David Walling, chief executive officer and Principal Investigator of the Collaborative Neuroscience Network, said the approval of Alkermes’ Aristada Initio represents an important addition to the treatment of schizophrenia patients due to its design to be able to aid in the initiation of Aristada treatment.

“For physicians and caregivers alike, the Aristada Initio regimen provides a level of confidence that patients can walk out the door with up to two months of coverage with a proven medication in their system. This supports continuity of care for patients and allows the care team to focus their efforts on other aspects of the treatment paradigm that contribute to long-term positive outcomes,” Walling said in a statement.

Schizophrenia is a chronic, severe and disabling brain disorder that affects about 2.4 million people in the United States. The disease is marked by hallucinations, delusions, depression, social withdrawal and disorganized thinking.

The Aristada Initio regimen provides patients with relevant levels of aripiprazole within four days of initiation. The result is an alternative initiation regimen that gives healthcare providers an additional tool to support patients during this critical time in their treatment journey, Alkermes said in its announcement. This is important for schizophrenia patients, the company said, because for those patients, medication compliance and continuity of care can be challenging. Alkermes added that the transition from inpatient care to outpatient settings can be an especially vulnerable time for that patient population.

Alkermes noted that although Aristada and Aristada Initio both contain aripiprazole lauroxil, the two medications are not interchangeable. That is due to differing pharmacokinetic profiles. Aristada Initio leverages the company's proprietary NanoCrystal technology and is designed to provide an extended-release formulation using a smaller particle size of aripiprazole lauroxil compared to Aristada, Alkermes said.

“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, ”Craig Hopkinson Alkermes chief medical officer, said in a statement.

The FDA approval comes on the heels of a stunning about-face for the regulatory agency on another Alkermes drug. In April, the FDA accepted Alkermes New Drug Application (NDA) for ALKS 5461, a treatment for major depressive disorder only weeks after the FDA rejected the NDA. The FDA initially refused the NDA for ALKS-5461 due to a lack of “insufficient evidence of overall effectiveness for the proposed indication.”

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