New drugs that only need to be taken once a week can change the condition of people with schizophrenia.
Star capsules gradually release medication from the stomach, maintaining stable drug levels while eliminating the daily pill burden that usually results in a lower dose. Results of clinical trials published in Lancet psychiatry show that weekly treatment symptoms are as effective as daily medications, which has the potential to solve one of the biggest challenges in schizophrenia care: keeping patients taking medications at all times.
How Star Technology Works
The capsule is approximately the size of a multivitamin. Once swallowed, it will expand into a six-armed star shape, too large to exit the stomach. Each arm slowly releases risperidone (a widely prescribed antipsychotic drug) over the course of a week.
“We have converted what has to be once a week to once a week, using technologies that can adapt to a variety of drugs,” explains Giovanni Traverso, assistant professor at MIT. “In an easy-to-manage system, the ability to deliver continuous levels of medications for a long time, making it easier to ensure patients are treated with medication.”
After about seven days, the arms will naturally split and exit through the digestive system. The technology took more than a decade to develop, starting with Traverso’s lab and then refined by MIT spinning company Lyndra Therapeutics.
The test results show hope
The third phase of the trial recruited 83 patients in five locations in the United States, although only 45 completed the full five-week study. The researchers found that throughout the week, the drug’s blood levels remained within the optimal range, and the difference was more than what daily medications usually see.
Using the standard positive and negative syndrome scales, patients’ symptoms remained stable throughout the study period. Side effects were minimal, and some participants experienced mild acid reflux and constipation early, but these side effects did not persist.
What makes these results particularly encouraging? The trial included a wide variety of participants: 75% male, 81% male or African American, with an average age of 49 years. This demographic performance is important because schizophrenia affects people of all backgrounds, but clinical trials do not always reflect this diversity.
Why weekly dosage is important
For schizophrenia, remembering that taking medications every day can be very challenging. Conditions themselves can impair memory and decision-making skills. When a patient misses a dose, symptoms often worsen, leading to potential hospitalization.
“In general, one of the biggest obstacles for people who care for chronic diseases is that medications are not consistent,” notes Leslie Citrome, the study’s lead author and clinical professor at the New York Medical School. “This leads to worsening symptoms, potential recurrence and hospitalization in the case of schizophrenia.”
Current alternatives to daily pills include injections of medication every two weeks to two months. However, these patients require medical provider visits and do not always like oral medications.
Persist in the challenge
Why do researchers target schizophrenia specifically for this technology? As Traverso explains: “The disease of neuropsychiatric disorders is long-term confirmed, in which case the disease can limit or impair people’s ability to remember to take medication.”
The weekly approach offers something unique: the convenience of oral medication without the burden of daily compliance. On the dosing day, the patient’s drug levels increased sharply, followed by a controlled decline within a week – both stayed within the treatment range.
Key test results:
- Weekly blood medication levels remain stable and effective
- Symptom control matches daily medication
- Of the 83 registered patients, only 47 completed the comprehensive study
- Minimal side effects, which do not persist beyond early treatment
- There is less variation in drug levels than daily administration
What’s next?
The researchers plan a large-scale Phase 3 study before seeking FDA approval of this risperidone delivery method. They also prepare trials for other drugs, including contraceptives.
Traverso reflects: “This does show that what we hypothesized a decade ago was that it was possible that this was a single capsule that provided a drug library within the gastrointestinal tract.” The results showed that in a large number of patients, the capsules achieved predicted drug levels and controlled symptoms.
This technology not only represents ease of scheduling. For patients with severe mental illness, consistent medication adherence may mean a difference between stability and crisis. Weekly medications that eliminate the burden of daily decision making can greatly improve outcomes.
Having oral medication options that ensure continuous administration may also reduce the stigma of injection therapy in some patients. Citrome stressed that “choosing to take medication once a week is an important option and can help many patients who prefer oral medications rather than injection-based formulas.”
As Robert Langer, professor of David H. Koch Institute and co-founder of Lyndra, said: “We are delighted that this technology, which started at MIT, has reached the point of a phase 3 clinical trial.”
The journey from laboratory concepts to potential treatment options illustrates how solving seemingly simple problems (such as remembering to take daily medications) requires complex engineering solutions. For millions of people with schizophrenia around the world, the project may soon translate into better, more manageable care.
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