Long-acting injectable (LAIs) antipsychotics are an important alternative to oral medications, particularly advantageous in the context of compliance management.
Despite the availability of oral atypical antipsychotics, Long-Acting Injectables (LAIs) offer significant clinical advantages such as effective long-term relapse prevention, increased patient compliance, ease of administration, reduced hospitalization rates, low risk of overdose, better correlation between dose and plasma concentrations, and overall lower cost of care
Currently available LAIs include Risperdal Consta, Invega Sustenna, and Invega Trinza from Johnson & Johnson, Abilify Maintena from Otsuka/Lundbeck, and Aristada from Alkermes
Government payers such as Medicaid and Medicare cover majority of LAI patients - making the reimbursement process favorable for LAIs. This is largely due to significant level of unmet medical needs and the clinical specificity of many schizophrenia drugs
Market players like Johnson & Johnson, Alkermes, Otsuka Pharma, and Lundbeck are focused on building their schizophrenia franchise for Long-Acting Injectables
J&J's LAI Franchise is driven by Invega Sustenna & Invega Trinza amid declining contribution from Risperdal Consta. Invega Sustenna is available as a pre-filled syringe that requires no refrigeration. Invega Sustenna offers multiple administration advantages over Risperdal Consta including a 4-week long-acting injection versus 2-week injection for Risperdal Consta, a more rapid onset of activity and no oral therapy supplementation on initiation resulting in increased adoption. Further, J&J’s Invega Trinza represents a potential improvement in the dosing regimen utilizing Alkermes’ NanoCrystal technology. The drug is priced in parity with Invega Sustenna, but patients can transition to Invega Trinza only after at least four months of treatment on Invega Sustenna
Aristada (Aripiprazole lauroxil) is the LAI version of Abilify and is the first antipsychotic to provide patients the flexibility of multiple dosing options. Abilify Maintena requires reconstitution, is available in only one maintenance dose (400mg), and allows only gluteal administration. In contrast, Aristada comes in pre-filled syringe with multiple maintenance strengths and allows for both deltoid and gluteal administration
In July 2018, the FDA approved combination of Alkermes’ Aristada Initio with a single 30 mg dose of oral Aristada for schizophrenia. Medication compliance and continuity of care can be challenging for schizophrenia patients. The Aristada Initio regimen will provide patients with appropriate levels of aripiprazole within four days of initiation. Previously, the first Aristada injection was to be administered after dosing with oral aripiprazole for 21 consecutive days
Rovi Pharma is developing an improved LAI version of Risperdal Consta (Risperidone ISM or DORIA) in a Phase III PRISMA-3 trial. According to clinical data from a Phase II trial, all patients achieved therapeutic levels post 2-8 hours of drug administration and sustained release of drug was available throughout the 28-day dosing period. Moreover, oral supplementation was not required. Risperidone ISM is expected to be launched in fourth quarter of 2019
Total prescription growth for the Long-Acting Injectables (LAIs) antipsychotics has remained strong and we think there will be broader penetration and sustained growth for the next several years driven by improved physician experience, a widening body of health economics outcome data, and increased marketing by multiple entrants. There are continued stream of evidences supporting the benefit and superiority of longer acting antipsychotics in improved patient outcomes. There is also increased body of evidence that support the correlation of longer dosing interval of LAIs in improving stability even after discontinuing of the medication.
In-depth report on global Long-acting injectable (LAIs) market by Grand View Research: