The vice president of Clinical Research at Eisai detailed why lorcaserin’s formula made it suitable for treating patients with Dravet syndrome.
"That nonclinical evidence about the networks, nonclinical model of zebrafish, and the case histories from physicians treating patients with epilepsy all impressed us and the FDA as well.”
Lorcaserin (Eisai), a selective serotonin 5-HT2c receptor agonist, will be evaluated in the phase 3 MOMENTUM 1 study (also known as Study 304; NCT04572243) in patients with Dravet syndrome (DS) after years of serving as the primary ingredient in Belviq, an FDA-approved weight loss medication. Belviq was withdrawn from the market in February 2020 after data from the CAMELLIA-TIMI 61 trial showed a numerical imbalance in the number of patients with malignancies.
At the time, Belviq was being used as an off-label treatment for patients with DS and other epilepsies but was not approved for this indication. The drug had shown enough therapeutic benefit to prompt patients and caregivers to continue to request it, despite being withdrawn from the market. Michael Irazarry, PhD, vice president, Clinical Research, Eisai, told NeurologyLive that the previously observed efficacy influenced the clinical trial, as well as the continued expanded access program.
In this interview, Irazarry detailed the basic scientific evidence that supported Eisai’s use of lorcaserin in a clinical trial for patients with DS. He also discussed why the drug became so sought out and the previously observed data that influenced beliefs on the potential of the drug.