The study, led by Andrew J. Cutler of SUNY Upstate Medical University and colleagues at Teva and IQVIA, was designed as a companion to the phase 3 SOLARIS trial, which tested TV-44749, an investigational once-monthly subcutaneous long-acting injectable olanzapine, in adults with schizophrenia. Rather than reanalyzing trial outcomes, the researchers administered separate online surveys to patients and healthcare professionals who had direct experience with the investigational product during the trial. Respondents were recruited from 18 United States clinical trial sites, and eligibility required at least 16 weeks of trial participation and at least two active doses of the medication. In total, 70 patients and 35 healthcare professionals, comprising 11 physicians and 24 nurses, completed the surveys, which used Likert scales to probe attitudes toward injection type, dosing schedules, initiation regimens, and the burden of post-injection monitoring.

The technical innovation at the heart of TV-44749 lies in its delivery system. The formulation combines olanzapine with a copolymer-based extended-release technology already proven in an established subcutaneous long-acting injectable risperidone product. When injected under the skin, the copolymers precipitate and form a depot that entraps the drug, releasing it slowly over the monthly dosing interval through diffusion and gradual degradation. This design eliminates the need for oral supplementation during initiation, a requirement that complicates many existing long-acting regimens, and, critically, it was engineered to avoid the overdose-like surge associated with intramuscular olanzapine pamoate that underlies PDSS. In the parent SOLARIS trial, TV-44749 demonstrated statistically significant and clinically meaningful efficacy versus placebo, with a systemic safety profile consistent with other approved olanzapine formulations, and as of May 2025 no suspected or confirmed PDSS events had occurred across 3,470 injections in the clinical development program.

The survey results on injection preference were among the most eye-catching findings. When shown images of needle length alone, 73 percent of patients preferred subcutaneous over intramuscular injections, and that preference climbed to 79 percent once diagrams of injection depth and angle were displayed. The reasons patients gave were refreshingly concrete: 67 percent cited the shorter and thinner needle, 44 percent said the procedure felt quicker, and 40 percent described it as less threatening. Healthcare professionals, by contrast, were almost evenly split, with physicians and nurses divided roughly down the middle between the two routes. Among clinicians who did favor the subcutaneous route, the dominant rationale, endorsed by more than 80 percent, was the perception that it would feel less threatening to patients, a reason only 40 percent of patients themselves endorsed, an early hint of the perception gap that runs throughout the study.

That gap widened when the surveys turned to post-injection monitoring. Ninety percent of patients said a long-acting injectable that required no post-injection observation period would be helpful, and 64 percent said they would be more open to trying one without such requirements. Roughly 45 percent of patients reported that a mandatory waiting period and accompaniment requirement would impose social, emotional, time, or financial costs, with the burden falling hardest on those who were employed, studying, or seeking work. On the clinical side, every single physician surveyed, 11 of 11, reported that post-injection monitoring would negatively affect their practice, citing space constraints, time burden, reduced staff efficiency, and the need to maintain access to emergency services. More than 90 percent of physicians said the monitoring requirements posed potential treatment barriers, compared with more than 66 percent of nurses, and 73 percent of physicians said the risk of PDSS would interfere with their ability to prescribe or administer long-acting injectables at all.

The divergence between physicians and nurses offers its own lesson. The authors suggest that physicians, who carry greater administrative and financial responsibility for their practices, feel the logistical weight of a three-hour monitoring protocol more acutely, while nurses, who often manage the monitoring itself as part of routine care, may perceive less incremental burden. Physicians were also more likely than nurses to report that PDSS risk and the associated regulatory requirements would interfere with effective prescribing. Given that PDSS occurs in fewer than 0.1 percent of intramuscular olanzapine pamoate injections, the study’s implication is sobering: a rare event has effectively constrained where and how an efficacious medication can be delivered, shaping clinical behavior far beyond the actual statistical risk.

Patients also placed markedly higher value than clinicians on the practical attributes of a long-acting regimen. Sixty percent of patients rated injection type as very important, compared with just 9 percent of physicians and 13 percent of nurses, and 63 percent of patients called the dosing schedule very important, versus 27 percent of physicians and 42 percent of nurses. Nearly all patients, 96 percent, valued a monthly dosing schedule, and 73 percent preferred an initiation regimen requiring only a single injection, a preference mirrored by more than three-quarters of healthcare professionals, who agreed they would recommend a one-injection initiation to patients. Most physicians and nurses, 82 and 79 percent respectively, said that dosing options comparable to oral medication, easing the transition from pills to injectables, would be a major benefit. The findings echo earlier companion surveys to the SHINE and ADVANCE studies, which similarly documented that patients and clinicians weigh long-acting injectable attributes differently, and they suggest clinicians may systematically underestimate how much patients care about convenience and delivery.

Satisfaction with the investigational medication itself was high across the board. Ninety-three percent of patients reported being satisfied or very satisfied with TV-44749 overall, along with 73 percent of physicians and 88 percent of nurses, with favorable ratings extending to the initiation regimen, monthly dosing schedule, and needle characteristics. Experience appeared to breed enthusiasm: 62 percent of patients with prior long-acting injectable experience said they were very satisfied, compared with 53 percent of those without, and healthcare professionals with ten or more experiences administering the drug reported higher satisfaction and greater willingness to continue than those with fewer exposures. Most tellingly, 83 percent of patients said they would continue taking TV-44749 if it became available after the trial, while 64 percent of physicians and 71 percent of nurses said they would keep prescribing or administering it. This pattern, in which familiarity with long-acting injectables correlates with more positive attitudes, aligns with the broader DECIDE survey of US clinicians and other studies showing that knowledge and hands-on experience erode resistance to depot medications.

The authors are candid about the study’s limitations. The sample was small and drawn exclusively from US trial sites, and by design the survey captured only patients who had tolerated the medication long enough to complete at least 16 weeks and receive two active doses, meaning the 50 of 604 trial participants who discontinued due to adverse events and the 8 who stopped for lack of efficacy are underrepresented. Responses were self-reported, collected within a clinical trial setting, and incentivized with honoraria, all of which could inflate positive perceptions, although respondents were assured of confidentiality and voluntary participation. Only about half of the nurses had actually administered the injections, and efforts to recruit caregiver perspectives were unsuccessful. Even so, the consistency of the findings with prior preference studies lends them credibility, and the core conclusion stands on solid ground: a subcutaneous long-acting olanzapine that requires no post-injection monitoring, no complex initiation, and no oral supplementation could remove the specific obstacles that have suppressed uptake of its intramuscular predecessor.

The broader significance of the study extends beyond a single drug candidate. Long-acting injectable antipsychotics are associated with better adherence, improved clinical outcomes, reduced hospitalizations, and lower care costs, yet they are prescribed to only about 13 percent of eligible patients in the United States, with even lower rates in China and other parts of Asia. The barriers are as much perceptual as pharmacological: fear of needles, negative past experiences, clinician uncertainty, cost, and fragmented guidelines all conspire against adoption. What this survey adds is a roadmap. It shows that patients care intensely about needle size, dosing simplicity, and freedom from post-injection observation, that clinicians often misjudge those priorities, and that direct experience with a well-designed formulation converts skeptics on both sides. Closing that perception gap through education, the authors argue, may be the most powerful intervention of all, one that could finally allow an efficacious, patient-friendly class of medications to reach the people it was designed to help.

Subject of Research: Patient and clinician attitudes toward a subcutaneous long-acting injectable olanzapine for schizophrenia

Article Title: Patient and Healthcare Professional Attitudes and Trial Experiences with a Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) for Schizophrenia Treatment

Article References: Cutler, A. J., Gonzalez, A., Suett, M., Shulman, K., Franzenburg, K. R., Tucker, J. L., Costa, E., & Lim, S. (2026). Patient and Healthcare Professional Attitudes and Trial Experiences with a Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) for Schizophrenia Treatment. Advances in Therapy. https://doi.org/10.1007/s12325-026-03697-y

Image Credits: AI Generated

DOI: 10.1007/s12325-026-03697-y

Keywords: schizophrenia, olanzapine, TV-44749, long-acting injectable antipsychotics, subcutaneous injection, PDSS, REMS, SOLARIS trial, medication adherence, patient preferences, healthcare professional attitudes, psychiatry