Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today 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 US Food and Drug Administration (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.
"This extended release formulation has the potential to offer once-daily dosing," said Jack Lief, Arena's President and Chief Executive Officer. "We expect the results from these trials will allow us to submit a New Drug Application with the FDA for the treatment of weight management later this year and may also support our efforts to further pursue additional opportunities within our lorcaserin lifecycle management portfolio."
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.
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