After reinvigorating a decades-old schizophrenia drug in an innovative long-acting treatment option, Teva is looking to unlock its next chapter of mental health treatment.
TEV’749 is a long-acting formulation of olanzapine, one of the most widely used atypical antipsychotic schizophrenia treatments to date. The drug was first approved in the 1990s and is currently marketed by Eli Lilly under the brand name Zyprexa.
Teva, which launched a Dr. Reddy’s-partnered generic to Zyprexa in 2011, spotted a gap in the market for an effective controlled-release version of the popular treatment. Long-acting medicines are especially crucial for schizophrenia treatment adherence, as about 80% of patients end up stopping treatment after two years, Teva's vice president of U.S. innovative medicines, Heather DeMyers, explained in a recent interview with Fierce Pharma.
While Lilly makes a longer-acting option of the drug called Zyprexa Relprevv, it carries a black-box warning for the rare but serious risk of post-injection delirium/sedation syndrome (PDSS).
Old drug, new innovations
Enter Teva and its SteadyTeq technology, which it licensed from MedinCell and first commercialized with Uzedy, a slow-release version of Johnson & Johnson’s schizophrenia med Risperdal (risperidone).
TEV’749 leverages the same SteadyTeq technology to deliver olanzapine as a once-monthly subcutaneous long-acting injection. With its controlled-release feature, the drug is intended to help patients cut the risk of relapse and boost treatment adherence, DeMyers said.
An innovative long-acting version of a decades-old schizophrenia treatment is just one example of Teva's efforts to “do things differently” in the central nervous system (CNS) space, DeMyers noted. In the phase 3 SOLARIS trial, TEV’749 helped adult schizophrenia patients achieve statistically significant improvements from baseline on the Positive and Negative Syndrome Scale at Week 8, with no reported cases of PDSS.
The drug forms part of Teva's growing focus on innovative offerings, along with Uzedy, which crossed the FDA finish line in 2023. The company’s top-selling innovative medicine, however, is Austedo, which is in line to pick up $2.5 billion in sales by 2027, CEO Richard Francis said in an interview earlier this year.
After nabbing its first FDA approval in 2017 for Huntington’s disease chorea, a common symptom of the degenerative disease that involves involuntary sudden movements, and a follow-up nod in tardive dyskinesia (TD), Teva has now racked up years of crucial experience in working with patients in the CNS space. Most recently, the Austedo franchise racked up another approval with Austedo XR, a once-daily, extended-release tablet formulation of the drug.
Austedo XR represents a key advancement as a flexible option for patients, DeMyers said. Still, the company is continuing to look at ways to further advance the therapy, such as with a four-week titration kit, and it's running a real-world study to learn more about treatment patterns and outcomes for TD patients on both Austedo and Austedo XR.
Peeling back the onion
The CNS and mental health space is rife with hurdles that could hamper a successful launch, starting at the very beginning of a patient’s treatment journey: diagnosis. Take Austedo, for example: TD and Huntington’s disease are commonly misdiagnosed due to the often subtle ways symptoms first present. In some cases, symptoms can lead doctors to a Parkinson’s disease diagnosis instead of TD, according to DeMyers.
Of course, even after diagnosis, the social stigma that many mental health conditions carry presents a significant barrier on its own. Despite the advancements being made in the space, the “only way” to ease the stigma is “getting people comfortable speaking about it,” DeMyers emphasized.
Teva is “not going to stop” exploring available opportunities to advance treatment as it “peels back the onion,” in the massively undertreated market, DeMyers said. Through real-world data, the company is diving deep into the nitty-gritty of the patient populations it serves to identify trends within underserved groups.
Recently reported interim results from the company’s IMPACT-TD Registry study, for example, suggested that fewer people with a psychotic disorder received a TD diagnosis compared to those with mood disorders, despite similar mean Abnormal Involuntary Movement Scale scores.
“We’re always looking at ways that we can bring in this data, and this will be able to indicate what other innovations we may need to do to help these patients,” DeMyers said. “There is still such an unmet need out there.”