Schizoaffective disorder

WEDNESDAY, Jan. 31, 2024 -- For people with schizophrenia hospitalized after a psychotic episode, getting a long-acting antipsychotic injection works far better than pills to keep them from returning to hospital care. That's the finding of a new study from researchers at Rutgers University in New Brunswick, N.J. They found that injected antipsychotic meds -- which provide continuous treatment from two weeks up to six months -- were 75% more effective in reducing rehospitalization, compared to the same meds in pill form. “I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” noted study lead author Dr. Daniel Greer , a clinical assistant professor at the Rutgers Ernest Mario School of Pharmacy. The findings were published recently in the Journal of Clinical Psychopharmacology . As Greer's team noted, expert guidance already recommends that people with schizophrenia receive long-acting antipsychotics by injection upon discharge from a hospital, rather than pills. But many patients, whether due to needle fears or cost issues, may still opt for pills. That's a real problem, Greer said, because "other studies on the use of antipsychotic medication have found that roughly three-fourths of patients do not take oral medications exactly as directed." Conversely, "it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor," he added in a Rutgers news release. In the new study, Greer's team tracked 30-day hospital readmission rates for 343 patients with schizophrenia or schizoaffective disorder discharged from a single hospital. Of that group, 240 opted for antipsychotic meds in pill form while the other 103 received a long-acting injection upon discharge. At the 30-day mark, only 1.9% of those who got the injection found themselves back in the hospital, compared to 8.3% who had been given pills, according to the study. The researchers noted that the 30-day window is clinically important, because research has shown that if symptoms of schizophrenia are successfully suppressed for a month, the odds of symptoms returning decline significantly going forward. One ongoing issue, however, is cost. Injections typically cost more than pills, so many insurers have balked at covering them. However, that's slowly changing as insurers begin to realize the longer-term savings. “The cost of the injections is far lower than the cost of hospital treatments,” Greer noted. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.” Sources Rutgers University, news release, Jan. 30, 2024 Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

WATERTOWN, Mass.--( BUSINESS WIRE )-- Lyndra Therapeutics ® , a clinical-stage biopharmaceutical company, today announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder. The STARLYNG-1 study is designed to bridge to the previously established safety and efficacy of immediate-release Risperdal for schizophrenia and bipolar disorder as agreed with the U.S. Food and Drug Administration. The pivotal study included participants with schizophrenia and schizoaffective disorder who were on a stable dose of an oral antipsychotic medication at the start of the study. The study assessed oral weekly risperidone 15 mg and 45 mg, equivalent to 2 mg and 6 mg daily Risperdal, respectively. A total of 90 participants were planned for the study, with a planned interim analysis after 46 participants. At the interim analysis, the study met the pre-specified primary endpoint, which includes the geometric mean ratio of the Week 5 oral weekly risperidone drug levels compared to the baseline immediate-release Risperdal drug levels. Oral weekly risperidone met the endpoint of a one-sided Cmin of >0.80; a one-sided Cmax of <1.25; and a two-sided Cavg of 0.80-1.40, with 90% confidence limits. With these positive results, the study was stopped early according to the pre-defined stopping criteria. “These positive data demonstrate that a single dose of oral weekly risperidone delivers comparable medication levels to daily risperidone, validating that Lyndra’s LYNX ® drug delivery platform may provide a medication option that significantly reduces dosing frequency,” said Lyndra Therapeutics’ Chief Medical Officer and President of Global Product Development Richard Scranton, MD, MPH. “For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes.” The study also met its secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score, a score used for measuring symptom severity in schizophrenia. One key potential benefit of the LYNX drug delivery platform is the ability to deliver more consistent levels of medication compared to daily dosing by reducing the peak to trough variation. Oral weekly risperidone (LYN-005) was generally safe and well tolerated. “The LYNX drug delivery platform has the potential to transform how we take oral medicines, and we are very pleased with the positive interim data for our lead asset oral weekly risperidone,” said Jessica Ballinger, Lyndra Therapeutics’ President and CEO. “We are eager to bring long-acting oral therapies to patients and are focused on advancing oral weekly risperidone into its remaining pivotal safety trial in 2024.” About the STARLYNG-1 (LYN-005-C-301) Study The STARLYNG-1 study was designed as a ~90-person pharmacokinetic (PK) comparability study that bridges to the previously established safety and efficacy of daily Risperdal. Due to its adaptive study design, at the interim analysis, the study could be stopped for success or continued for sample size re-estimation. The study aimed to evaluate the pharmacokinetics of 15 mg and 45 mg oral weekly risperidone (LYN-005) compared to 2 mg or 6 mg daily Risperdal. Following the STARLYNG-1 pivotal PK study, Lyndra plans to conduct STARLYNG-2, its pivotal safety study, which will be a six-month, double-blind study to characterize the safety profile of Lyndra’s LYNX ® drug delivery platform, beginning in the second half of 2024 in patients with schizophrenia and schizoaffective disorders. About the LYNX ® Drug Delivery Platform The LYNX drug delivery platform offers the possibility of transforming how people take pills. Current oral pills are limited to ‘extended release’ formulations, which do not last for more than a day. The once-a-week dosing offered by Lyndra’s LYNX drug delivery platform is enabled by more than 50 patented innovations in design, engineering and materials science to achieve this dramatically reduced dosing frequency. The platform originated from the Langer Laboratory, with which Lyndra has an exclusive technology license. About Lyndra Therapeutics Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra’s LYNX ® drug delivery platform is one of the most significant advances in oral drug delivery in decades, creating medicines that last for a week or longer in an oral dosage form. Lyndra’s initial focus is on developing therapies in psychiatry, cardiometabolic diseases and other conditions that would benefit from dramatically reduced dosing frequency. Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. Since the founding of Lyndra, the company has received product funding from the Bill & Melinda Gates Foundation, the NIH, AbbVie and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, MA, and has a state-of-the-art GMP manufacturing facility in Lexington, MA. For more information, visit https://lyndra.com .

Pictured: Man leaning against wall/iStock, KatarzynaBialasiewicz Less pills taken by schizophrenia patients are potentially on the horizon, based on an interim analysis of a Phase III study. Lyndra Therapeutics reported Thursday that its weekly formulation of risperidone is as effective as Johnson and Johnson’s immediate-release, daily Risperdal. The Phase III study was stopped early due to positive primary endpoint results from the mid-study analysis, the company said. Lyndra’s LYN-005 was administered to adults living with schizophrenia and schizoaffective disorder. The once-a-week oral formulation delivered “comparable medication levels” to J&J’s immediate-release Risperdal (IR risperidone), according to Thursday’s announcement. “For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes,” Lyndra’s CMO Richard Scranton said in a statement. Adherence is a primary concern for patients living with schizophrenia and schizoaffective disorder, as well as their caregivers. Daily risperidone is one of the most prescribed treatments for schizophrenia. Research found around 60% of patients report low medication adherence with almost all reporting at least moderate struggle, according to Lyndra. In addition to meeting its primary endpoint, the pivotal pharmacokinetic study also met secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score. The company believes its LYNX drug delivery platform benefits patients by delivering more consistent levels of medication, reducing the peak to trough variation of daily dosing. Lyndra will launch a six-month, double-blind pivotal safety study in the second half of 2024 for patients with schizophrenia and schizoaffective disorders. LYN-005 is also being studied in bipolar I disorder. Luye Pharma had a long-acting version of risperidone for both schizophrenia and bipolar I disorder approved by the FDA in January 2023. Rykindo is an intramuscular injection given once every two weeks. Lyndra closed a $101 million Series E raise in December 2023 after a $20.3 million Series D financing in June 2023. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached a tkate.goodwin@biospace.com and on LinkedIn.