Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., has officially published data from a patient and healthcare professional (HCP) attitudes and experiences study, which follows up on a successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) that evaluated the company’s TEV-‘749 therapeutic.
Going by the newly-published data, more than 92% of patients, 87% of nurses and 72% of physicians were either satisfied or very satisfied when asked about TEV-‘749, overall, including initiation regimen, monthly dosing schedule, and dosing options.
Before we dig any further, though, we must take into account how, after almost 30 years of use, olanzapine is now one of the most commonly prescribed second-generation oral antipsychotics for treating schizophrenia, In this regard, Teva’s Phase 3 SOLARIS trial program had previously studied the potential of TEV-‘749 and its innovative drug delivery technology as a long-acting injectable (LAI) subcutaneous formulation of olanzapine that may also help address the risk of Post-Injection Delirium/Sedation Syndrome (PDSS).
“Olanzapine is foundational to the treatment of schizophrenia; however, I have seen first-hand the adherence challenges faced by patients and caregivers with daily oral options,” said Andrew J. Cutler, MD, Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University and Chief Medical Officer, Neuroscience Education Institute. “The potential of TEV-‘749 as a long-acting formulation of olanzapine that also may not carry a risk for PDSS and the accompanying risk evaluation & mitigation strategy (REMs) and post-injection observation period could be instrumental in helping to treat more people with schizophrenia.”
Anyway, more on the same would reveal how this prospective, cross-sectional, observational and online survey study recruited patient (n=70) and HCP participants (nurses: n=24; physicians: n=11) who had two or more experiences with TEV-‘749. The survey effectively collected information on participants’ demographics and clinical characteristics, as well as their attitudes on and experiences with LAI treatment attributes, delivery of care, and treatment satisfaction.
Talk about the published results on a slightly deeper level, we begin from injector-type preference, where a majority of patients were found to prefer subcutaneous (SC) versus intramuscular (IM) injection (78.6% vs. 21.4%, respectively). You see, over 67.3% of patients indicated the needle size as the main reason for their preference.
As for HCPs, SC versus IM preference was balanced among physicians (54.6% vs. 45.5%, respectively) and nurses (both 50.0%).
Next up, we must dig into post-injection monitoring requirements. Here, even with low levels of social, emotional, financial or time impact, almost all the recruited patients noted that it would be helpful to have an LAI without a post-injection monitoring period (90.0%) or caregiver accompaniment requirement (92.9%).
On the other hand, the majority of physicians (>90%) and nurses (>66%) were found to agree with the patient contingent, as they deemed post-injection monitoring period may present potential treatment barriers and clinical challenges that could impact patients’ use of LAIs.
For better understanding, at the moment, olanzapine LAI has a three-hour post-injection monitoring requirement.
Another detail worth a mention here is rooted in the drug’s initiation regimen. Basically, when starting an LAI, most participants said they preferred an initiation regimen which mandated only one injection versus more complex regimens that are known for requiring concomitant oral medications or multiple injections (patients: 72.9% vs. 27.1%; physicians: 90.9% vs. 9.1%; nurses: 79.2% vs. 20.8%).
Moving on to the topic of dosing schedule, it showcases how a majority of participants valued monthly dosing schedule to a substantial degree (patients: 61.4%; physicians: 72.7%; nurses: 66.7%).
Rounding up highlights would be the assessment’s focus on gauging TEV-‘749 satisfaction. You see, almost all participants were found to have favorable responses (satisfied or very satisfied) regarding the initiation regimen, dosing schedule, and trial medication overall (patients: >92%; physicians: >72%; nurses: >87%), and responded favorably regarding continuing TV-44749 (patients: 82.9%; physicians: 63.6%; nurses: 70.8%).
In fact, patients who had prior experience with LAIs were more likely to indicate they were “very satisfied” with trial medication overall (61.9% vs 53.1%). Similarly, HCPs with more (≥10) TV-44749 experiences showed greater probability of rating it favorably (88.9% vs 76.5%) and be willing to continue treatment with TV-44749 (83.3% vs 52.9%).
