A new phase II study suggested improved quality of life and treatment adherence in schizophrenic patients with a novel, ultra-long-acting formulation of risperidone (LYN-005). The study comprised of 32 schizophrenia patients received immediate-release (IR) risperidone 2 mg or 4 mg and were randomized to either of the four groups, IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone or to LYN-005 matched placebo and IR risperidone 2 mg or 4 mg. LYN-05 once weekly for three doses and IR risperidone once daily were administered.
- Peak concentration was achieved within day 3 of administration of Lyn-005 and peak-exposure rates were lower than IR Risperidone.
- Around 85% of participants appeared to tolerate LYN-005 well.
- About 75% of patients who received LYN-005 demonstrated the presence of adverse effects such as gastrointestinal effects (54%) with a greater incidence in the 28 mg group.
- Although, the incidence of adverse events was higher, LYN-005 had milder AEs than IR and the incidence dropped from 58% patients after the first dose to 18% after the third dose.
This oral ultra-long acting once-a-week formulation may be useful in a group of patients who are phobic about needles and have a hard time following the therapy.
