LCP-Feno is designed to be an AB-rated, substitutable version of Tricor 145mg, currently marketed in the US by Abbott under the name Tricor and in Europe by Solvay under the name Lipanthyl.
In collaboration with Sandoz, LifeCycle Pharma is currently preparing for the initiation of pivotal studies to complete all the necessary requirements for an US abbreviated new drug application filing.
Michael Beckert, chief medical officer and executive vice president of LifeCycle, said: “We are extremely pleased to have shown bioequivalence of LCP-Feno and Tricor in this pilot study. This is another important milestone for the company, and a clear validation of the breadth of application as well as versatility of the MeltDose technology. The next step will be to prepare for pivotal pharmacokinetic studies to confirm these results.”