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ESTEVE Announces the Publication of Comprehensive Phase I Data for a Novel Oral, First-in-class New Chemical Entity (NCE),E-52862, a Sigma-1 Receptor Antagonist (S1RA) Being Developed for Pain
Date:9/4/2012

(telemetry, triplicate 12-lead ECGs, 24-hour Holter ECGs). Pharmacokinetic assessments were performed in each study and results demonstrate a favourable pharmacokinetic and pharmacodynamic profile, supporting oral, once-daily administration of E-52862.

The E-52862 Phase I programme is now complete and included over 300 human subjects (more than 250 received E-52862).  Results from the overall programme show favourable safety, tolerability, pharmacodynamic and pharmacokinetic profiles at all doses of E-52862 tested.

Today, the E-52862 clinical programme focuses on pain management - highlighting both neuropathic pain and the potentiation of opioid analgesia. The Phase II clinical trial programme for E-52862 began early in 2012.  The clinical project leader for E-52862, Roser Vives, M.D. commented that "Because of the MOA and data available to date, we are evaluating E-52862 in four different types of neuropathic pain and for treatment of pain in patients receiving opioids (for the enhancement of the analgesic effect and better tolerability). E-52862 also has potential applications for other neurological and psychiatric indications".

E-52862, whose MOA is both novel and complementary to that of other analgesic compounds, could provide a much-needed addition to future pain management choices with, perhaps, the option to be used as monotherapy, as well as in combination with other pain relief compounds, depending on the type of patient and clinical indication.

About ESTEVE

ESTEVE is a leading pharmaceutical chemical group based on Barcelona (Spain) with significant international presence.  Since it was founded in 1929, ESTEVE has been firmly committed to excellence in healthcare, dedicating efforts to innovative R&D of new medicines for unmet medical needs and focusing on high science and evidence-based research. ESTEVE has a strong partnership approach to drug discovery, development and commercialisation. The company
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