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Esteve announces positive results from its phase ii clinical study of e-58425 in acute pain

By 17 de October de 2013November 18th, 2020No Comments
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Drug Discovery Center of Esteve is located at the Parc Científic de Barcelona. © PCB.
 17.10.2013

Esteve announces positive results from its phase ii clinical study of e-58425 in acute pain

Esteve announces positive top line results from its recently completed phase II trial, which was designed to evaluate the efficacy and safety of E-58425 in acute pain. On Setember 2012, the company has moved its Centre for Drug Research and Development to the Parc Científic de Barcelona in an attempt to shorten development time and speed up the arrival to market of innovative new drugs. Esteve's dedicated in-house R&D team is focused on the development of novel pain medicines, an area of high unmet medical need.


E-58425 is a patented new product co-crystal entity of two active pharmaceutical ingredients (APIs). Phase I clinical testing demonstrated that the new co-crystal entity exhibited distinct and optimized pharmacokinetic properties with respect to those of the simple co-administration of the two individual APIs, thus strongly differentiating E-58425. The positive phase II data presented here confirm that E-58425 delivers synergistic efficacy accompanied by an excellent safety and tolerability profiles.

The overall Phase II results support the Product Concept of E-58425: Clinically relevant and robust pain relief achieved at low doses of E-58425 (hence low dose of each active ingredient) associated with a better safety & tolerability profile and risk-benefit ratio. Therefore, E-58425 has demonstrated a strong improvement in efficacy and has significantly improved the risk-benefit ratio compared to that expected for the individual components.

The results also support that while both active ingredients act via different complementary central and peripheral mechanisms of action for synergy in efficacy, they have little or no overlap in safety, tolerability and metabolism, and therefore, neither unpredictable safety concerns nor clinically relevant drug-drug interactions between the active principles are expected. Esteve is currently seeking partners to support the further development of E-58425.