Novel Long-Acting Oral Formulation of Risperidone Shows Promise in Phase 3 Trial
According to results from the phase 3 STARLYNG-1 trial, a long-acting oral weekly formulation of risperidone, LYN-005, offered sustained release of the medication at therapeutic concentrations with similar bioavailability to immediate-release risperidone in patients with schizophrenia. The development of this novel drug delivery technology may prove beneficial in improving medication adherence, a common barrier to schizophrenia treatment.
“Not everyone is willing to receive a long-acting injectable antipsychotic, and problems with adherence get in the way of remaining well,” lead author Leslie Citrome, MD, MPH, Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, New York, told Psych Congress Network. “A once-a-week oral formulation may fill this unmet need.”
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Published in The Lancet Psychiatry, the open-label, non-randomized trial enrolled clinically stable participants with schizophrenia or schizoaffective disorder residing in an inpatient facility for 5 weeks (excluding days 9–13). During a 7-day run-in period, participants first received either 2 mg or 6 mg of immediate-release risperidone. They then received 5 doses of long-acting oral weekly LYN-005 (either 15 mg or 45 mg), with a supplemental half-dose of immediate-release risperidone in the first week. In their pharmacokinetic analysis (n = 44), the researchers compared the minimum concentration (Cmin) of LYN-005 at weeks 1 and 5 and the average (Cavg) and maximum (Cmax) concentrations at week 5 with those of the immediate-release risperidone on day 7 of the run-in period, to assess if the long-acting formulation maintained therapeutic concentrations over the 5 weeks.
The geometric mean ratios of LYN-005 versus immediate-release risperidone were 1.02 (90% CI, 0·93–1·12) for Cmin at week 1. At week 5, the geometric mean ratios were 1.04 (90% CI, 0.87–1.23) for Cmin, 0.84 (0.77–0.92) for Cmax, and 1.03 (0.93–1.13) for Cavg. According to these data, LYN-005 offered a sustained release of the medication and kept patients clinically stable over the 5-week period, with minimal safety concerns.
If approved by the Food and Drug Administration (FDA), the long-acting formulation could simplify treatment adherence for patients by mitigating pill burden or reducing reliance on injections. “Medication can be administered under supervision or with simple weekly reminders,” Citrome noted. “A reminder once a week is less intrusive and bothersome than reminders every day.”
Looking ahead, Dr Citrome told PCN that “a longer-term study would be helpful to characterize ongoing acceptability of this new formulation.” The formulation’s novel drug delivery method may also prove beneficial for the treatment of other disorders, as “the use of this delivery technology can be adapted for other medications, including antidepressants and other antipsychotics.”
Funding for the study was provided by Lyndra Therapeutics.
