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EpiCept Reports Clearance of U.S. IND for LidoPAIN SP; First Sterile Pharmaceutical Patch for Post-Surgical Incisional Pain Relief
ENGLEWOOD CLIFFS, N.J. -- EPICEPT CORPORATION, a specialty pharmaceutical company focusing on innovative pain relief therapies, today announced that the U.S. Food and Drug Administration has cleared the IND for LidoPAIN SP, a lidocaine-based topical hydrogel patch, to begin human clinical trials in the United States. LidoPAIN(R) SP would be the first sterile hydrogel patch for use in ameliorating pain from surgically closed wounds if approved for marketing. Phase II U.S. efficacy trials are expected to begin in the first quarter of 2003.
"EpiCept looks forward to adding to a growing body of placebo-controlled human data which support the concept of peripheral analgesia and EpiCept's portfolio of topical pain products," stated Jack Talley, CEO. "Our goal is to provide novel and effective approaches for relieving pain and minimizing the use of systemic narcotics, opioids and non steroidal anti-inflammatory drugs."
Talley continued, "marketing research has told us that general surgeons would embrace a product like LidoPAIN SP, especially since this topical approach to pain relief has not yet been shown to have any of the bothersome side effects seen with the narcotics currently being used".
EpiCept has recently completed a Phase II placebo-controlled clinical trial in Europe for LidoPAIN SP. Results from this trial are expected in the first quarter of 2003. LidoPAIN SP is protected by several granted and pending composition and method of use patents in the U.S. and abroad.
Post-operative pain is typically acute, mild to severe in intensity, can be somatic or visceral and is the direct result of a surgical procedure. Surgical procedures such as hernia repair, plastic surgery, breast biopsy and arthroscopy are minimally invasive and generally produce minor surgical trauma. These procedures are usually performed on a same-day or outpatient basis and are followed with a course of systemic NSAIDs or opioids depending on the severity of the pain. Due to a changing standard of care, which involves earlier discharge of patients, an increasing medical need exists for safer analgesics for these patients. It is estimated that approximately 30 million ambulatory surgical procedures are performed annually.
EpiCept is a specialty niche pharmaceutical company that applies proprietary topical technologies to develop new drugs and improved formulations of existing drugs for the prescription pain management market. The pain product candidates address unmet medical needs for lower back pain, post-operative incisional pain and neuropathic pain as well as other pain indications. EpiCept's product candidates offer potentially enhanced pain relief, improved side effect profiles, are potentially additive to systemically administered therapies, can eliminate systemic drug interactions and can be opioid sparing in their analgesic effect. The company is developing pain products for a focused set of clinical uses in back pain, surgical pain, and peripheral neuropathy.
EpiCept is a privately held company whose investors include major financial institutions. The management team is based at the corporate headquarters in Englewood Cliffs, N.J., and in Munich, Germany.
Source: EpiCept Corporation