Medix has submitted a new drug application to the Mexican food and drug administration — Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS — seeking approval of tesofensine for the treatment of obesity.
“The filing of this new drug application in obesity represents an important milestone for Saniona and rounds off a year in which we have made tremendous progress,” Jørgen Drejer, Saniona’s CEO, said in a press release.
“As well as addressing a major market in Mexico, with the potential for a new revenue stream, this filing also supports development of our proprietary product Tesomet, in which tesofensine is the key active ingredient,” Drejer added.
Specifically, tesofensine prevents the reuptake of serotonin, norepinephrine, and dopamine, which are molecules used by nerve cells to communicate with each other. By increasing the amounts of these neurotransmitters outside brain cells, tesofensine is intended to decrease signals between cells, and thereby reduce appetite.
The other component of Tesomet is metoprolol, which is used to resolve the abnormal heart rate associated with tesofensine.
Results of a six-month extension of a Phase 2a clinical trial (NCT03149445) revealed that a 0.25 mg daily dose of Tesomet could significantly reduce weight, body mass index, and excessive appetite in three adolescents with PWS, compared with a lower dose (0.125 mg/day) and a placebo. Earlier results in adults with PWS had indicated beneficial effects on weight loss and excessive eating.
Based on these findings and an ongoing Phase 2a trial in hypothalamic obesity (NCT03845075), Saniona is planning to conduct Phase 2b and Phase 3 studies to help support the approval of Tesomet for PWS and hypothalamic obesity in the United States and the European Union.
Saniona formed a partnership with the Mexico-based Medix in 2016. Under the terms of this agreement, Medix obtained the rights to develop and sell both tesofensine and Tesomet in Mexico and Argentina.
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