Repros Therapeutics provides a further update on the clinical development of Proellex 25mg and 12.5mg doses.
Repros’ recent decision to discontinue the use of the Proellex 50mg dose in its ongoing clinical studies was based on observations of a dose-related increase in liver enzymes in a low percentage of women. The company believes that the 25mg and 12.5mg doses would offer comparable efficacy benefits while providing an improved safety profile.
From completed studies as well as from an ongoing large open label trial, it has been determined that the drug appears to be well tolerated.
Repros believes that the decision to move forward with the 25mg and 12.5mg doses will improve the benefit/risk profile of Proellex. Additionally, Repros believes that any new studies required for the approval of the 12.5mg dose will not adversely impact anticipated timing of NDAs for Proellex.
Paul Lammers, President of Repros Therapeutics, said: “Drug development is a dynamic process, the aim of which is to try and bring to market a product with an optimal balance between benefits and risks that will address an unmet medical need in patients. Our decision to stop the 50mg dose supports this concept, as well as demonstrates our commitment to safeguarding the well-being of the women participating in our clinical trials.”