Encore Therapeutics Inc. (ETI) Reports Additional Proof of Concept Results on its Extended Release Ropivacaine Injectable Gel for Postoperative Pain ManagementCARLSBAD, Calif.--(BUSINESS WIRE)--Aug 2, 2007 - ETI today reported on two pre-clinical studies demonstrating that its intradermal extended release Ropivacaine gel formulation (ETI-211) has a markedly improved safety and pharmacokinetic (PK) profile when compared to the currently marketed ropivacaine solution formulation.
No apparent toxicity was shown with the ETI-211 gel at the highest ropivacaine dose used (2,054 mg/kg), in marked contrast to the 54 mg/kg lethal dose for the solution formulation. The PK study showed that ETI-211 produced a greatly extended release profile lasting for 6 days and a 5-10 fold reduction in Cmax compared with the currently marketed solution formulation. The controlled and sustained PK profile is highly desirable since ETI-211 is designed to maintain the drug at the local site of administration. The PK result is consistent with the previously reported sustained pain-relief efficacy data.
ETI-211 is a proprietary non-liposomal phospholipid gel (PG) formulation that incorporates the drug in a single-phase depot system. The gel is capable of delivering the drug for 3-7 days with low burst potential and is made with existing injectable phospholipids and other components that have been used in previous FDA approved drug products. Previously reported results have shown that ETI 211 outperformed another liposomal anesthetic depot formulation in terms of duration of action in pre-clinical models.
"This study coupled with our previously reported data showing a three day duration of local anesthetic efficacy provides a pharmacologic profile for ETI-211 that is consistent with the product characteristics we intended," stated ETI Chairman and CEO, Dr. Paul J. Marangos. "This technology platform can provide a range of proprietary products with lower development risk and shorter timelines to revenue generation." Dr. Andrew X. Chen, Chief Scientific Officer at ETI, further commented, "The PG technology is a new drug delivery approach to provide extended action (3-7 days) for a wide variety of drugs by subcutaneous, intramuscular or intratumoral injection."
The market for postoperative pain management is estimated at $5.7 billion and is growing rapidly. ETI-211 is designed to capture a significant portion of this market and increase the use of local anesthetics in surgical care while at the same time reducing the use of systemically administered opiates.
About ETI - ETI was founded by Drs. Paul J. Marangos and Andrew X. Chen to extend and enhance the action of existing drugs through novel formulation strategies. The Company has devised multiple novel applications of its proprietary PG technology and is seeking to engage in development and marketing partnerships with other companies to bring these products to market and to potentially apply the PG technology to other products.
Posted: August 2007