Eisai and Arena Pharmaceuticals have completed two Phase I registrational clinical trials to show bioequivalence of an investigational once-daily extended release (ER) formulation of lorcaserin, as compared to twice-daily immediate release formulation.
The US Food and Drug Administration (FDA) has granted approval for the twice-daily immediate release formulation of lorcaserin, which is marketed as Belviq.
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If approved, the investigational extended release formulation will be marketed as Belviq XR, which is the brand name conditionally approved by the FDA.
Around 36 healthy adult subjects were included in each of the two randomised, crossover trials, which evaluated the safety, tolerability, pharmacokinetics and bioavailability of an extended release formulation of lorcaserin.
In each trial, patients were divided into two treatment groups and received both doses in a two-way crossover sequence.
In the first trial, patients were dosed under fasted conditions either 10mg twice-daily (BID) immediate release or 20mg once-daily (QD)extended release, while patients in the second trial were given either 20mg QD extended release in the fasted state or 20mg QD extended release in the fed state.
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By GlobalDataArena president and chief executive officer Jack Lief said: "This extended release formulation has the potential to offer once-daily dosing.
"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."
Belviq is approved for weight management by the FDA and the Ministry of Food and Drug Substances in South Korea.
Eisai and Ildong market and distribute Belviq in the US and South Korea, respectively, while Arena manufactures and supplies the finished commercial product from its facility in Switzerland.
