Date: 2015-04-10
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Eisai (Japan) Arena Pharmaceuticals (USA - CA)
Product: once-daily extended release formulation of lorcaserin
Action
mechanism: serotonin receptor agonist
Disease: weight management
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On April 10, 2015, Eisa and Arena Pharmaceuticals announced the completion of two Phase 1 registrational clinical trials that Eisai and Arena believe demonstrate bioequivalence of an investigational once-daily extended release formulation of lorcaserin, as compared to the twice-daily immediate release formulation approved by the FDA and marketed as Belviq®. If approved, the extended release formulation is expected to be marketed as Belviq® XR, which is the brand name conditionally approved by the FDA
Each of the two randomized, crossover trials evaluated the safety, tolerability, pharmacokinetics and bioavailability of an extended release formulation of lorcaserin in 36 healthy adult subjects. Patients in each trial were divided into two treatment groups and received both doses in a two-way crossover sequence. Patients in the first study were dosed under fasted conditions either 10 mg twice-daily (BID) immediate release or 20 mg once-daily (QD) extended release. Patients in the second study were dosed either 20 mg QD extended release in the fasted state or 20 mg QD extended release in the fed state.
The most common treatment-emergent adverse events were similar to those seen in the Phase 3 clinical trials of BELVIQ, and included mild or moderate headache, constipation, dizziness and nausea. There were no discontinuations for adverse events, and no serious adverse events were observed. Lorcaserin extended release formulation is investigational and not approved by any regulatory agency.
