Depomed has reported top-line data from its Phase II trial of DM-1992 conducted in patients with advanced Parkinson’s disease with motor fluctuations.
The active-controlled, open-label, crossover study was designed to assess the company’s investigative novel gastric-retentive, extended-release formulation of carbidopa/levodopa.
Study randomised 34 subjects with DM-1992 twice daily or a generic version of immediate-release carbidopa/levodopa (IR CD/LD) dosed as needed.
Depomed president and CEO James Schoeneck said; "We will continue to evaluate these data, as we consider partnering opportunities for DM-1992 and monitor competitive developments."
All the patients were maintained on existing Parkinson’s medications, and baseline measurements were recognised along a patient self-assessment period of three days.
Over a period of ten days that comprised of a dose optimisation period of six days, patient self-assessment period of three days, and one in-clinic day, DM-1992 and IR CD/LD were administered.
The change in percent ‘off’ time during waking hours, as measured by patient self-assessment during the treatment period relative to the baseline period is the primary endpoint for the study.
Patients’ mean baseline off time during waking hours was 5.4 hours per day, compared to 4.5 hours during the DM-1992 self-assessment period and 5.5 hours for the IR CD/LD comparator, according to the company.
The study demonstrated a statistically significant difference in reduction in percent ‘off’ time during the DM-1992 patient self-assessment period compared to the IR CD/LD comparator.
Patients were allowed to take IR CD/LD as rescue medication in case of an off state for more than two hours.
1.3 mean daily doses of rescue medication was taken by patients during the DM-1992 patient self-assessment period, compared to 0.2 mean daily doses for the IR CD/LD comparator.
DM-1992 was well tolerated in the study, which reported no serious adverse events.