In part one of this two-part piece, we spoke with Andreas Schreiner who told us about the challenges of conducting research in patients with schizophrenia.
Schreiner is the executive director of medical affairs neuroscience and analgesia at Premier Research, which is currently conducting a trial on long-acting injectable antipsychotics.
OSP: What are the benefits of long-lasting antipsychotics?
AS: Long-acting antipsychotics (LAIs) have historically been used for the treatment of refractory schizophrenia and in patients with chronic adherence issues. However, proponents of this mode of administration believe that LAIs are underutilized and that their innate treatment consistency has the potential to improve the prognosis of patients with schizophrenia and reduce associated comorbidities.
In fact, recent randomized controlled trials and meta-analyses have demonstrated the efficacy of intramuscular injections of long-acting antipsychotic medications and signal that their use should be expanded into a broader range of clinical settings and patient populations.
Daily-dosed medications, especially in a patient population characterized by disorganized thinking and behavior, can be a significant barrier to the effective treatment of schizophrenia.
An estimated 40 to 60% of patients with schizophrenia struggle to adhere to their medication regimens, and as the time span of incomplete treatment increases, so does the risk of disease-associated morbidity and mortality. For effective symptom control and relapse prevention, studies have shown that patients must adhere to their medication 75 to 80% of the time.
Due to their longer half-life, LAIs offer a protective period if patients miss a dose. LAIs also offer an increased interval for providers to reach out to their patients if a dose is missed before blood levels decrease to the point of relapse.
OSP: Why have patients been slow to accept injectable drugs in this space?
AS: For many patients, an injection is anxiety-provoking. In addition, patients may fear loss of control or ownership over their lives and their treatment if switched to an injection instead of a daily oral medication.
OSP: Have caregivers also been slow to accept them?
AS: The current standard of care guidelines indirectly support the limited use of LAI antipsychotics for the treatment of schizophrenia but emphasize that treatment planning should revolve around the patient’s comfort level with medication.
Physicians are often hesitant to suggest LAIs because they are concerned about damaging the therapeutic relationship, especially if the patient was recently diagnosed or has negative feelings about injections. It has been shown that low use of LAIs in clinical practice is also related to providers assuming a patient will have a negative reaction to the suggestion of LAI treatment.
In addition, providers may be concerned that, due to the long half-life of LAIs, an adverse reaction to treatment would be more severe and difficult to reverse than with its oral counterpart.
OSP: What do you expect from the next five, ten years?
AS: I hope that in the next five to ten years we will be able to better individualize treatment for patients suffering from schizophrenia, i.e. be able to predict clinical response and side effects based on genetic and clinical parameters as well as some biomarkers.
In addition, I would also expect a few new treatment options addressing the unmet needs of schizophrenia, in particular, negative and mood symptoms. However, in my experience, those new medications likely will not work in monotherapy but rather would be used as an addition to an established underlying antipsychotic medication.