EpiCept Initiates Two Phase IIb Trials with NP-1
EpiCept Corporation announced the initiation of two Phase IIb trials with EpiCept NP-1, a topical prescription analgesic cream for the long-term relief from the pain of peripheral neuropathies.
Peripheral neuropathy, a medical condition caused by damage to the nerves in the peripheral nervous system, affects more than 15 million people in the U.S. alone and is associated with such conditions as herpes zoster (shingles), diabetes, HIV/AIDS and other diseases.
The two Phase IIb trials will enroll a total of 700 patients. The first trial is a 200 patient, placebo- controlled study of NP-1 in patients with diabetic peripheral neuropathy (DPN). More patients suffer from DPN than any other type of neuropathic pain. Only two medications are currently approved for this use. The trial is intended to confirm and expand upon earlier work on a smaller scale which provided an efficacy signal in this type of neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected by the fourth quarter of 2007.
The second trial is a 500 patient, placebo- and active-controlled trial in peripheral herpetic neuropathy. This trial will compare the efficacy and safety of NP-1 vs. gabapentin as well as placebo. NP-1 has already shown in a prior 149 patient, Phase II dose ranging study a pronounced efficacy signal vs. placebo in this type of neuropathic pain. This active comparator trial is one of the first such efforts to examine any candidate compound at this scale in neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected in the first quarter of 2008.
The results of these trials are intended to broaden NP-1's labeling within peripheral neuropathies and raise the product candidate's future market potential. There are only four drugs approved for the treatment of neuropathic pain and three of the four have had annual sales in excess of $1 billion. NP- 1, were it to be approved, may have a similarly large market potential.
"We are pleased to advance this important product candidate and to have achieved another key milestone for EpiCept in 2007," stated Jack Talley, President and Chief Executive Officer of EpiCept. "We believe NP-1 has the largest market potential of any of our pain product candidates and is a valuable component of our diversified portfolio of pain management programs and high-potential compounds for the treatment of cancer. The results of our NP-1 Phase IIb trials should enable us to broaden the known therapeutic signal with NP-1 and establish the drug as a superior therapy compared to the market leader, gabapentin."
EpiCept's Approach to Treating Pain: EpiCept's pain product candidates are designed to topically deliver FDA- approved pain management therapeutics directly to the surface of the skin, thereby blocking the ability of peripheral nerve receptors to transmit pain messages to the brain, which in turn will provide significant pain relief, with fewer adverse side effects, fewer drug to drug interactions and lower potential for abuse than systemically delivered analgesics. In addition to NP- 1, EpiCept is also pursuing two other pain product candidates that are nearing pivotal scale clinical trials: LidoPAIN(R) SP, a sterile analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wound; and LidoPAIN(R) BP, a 24-hour patch that provides topical delivery of lidocaine for acute back pain. EpiCept has a worldwide commercialization agreement for LidoPAIN BP with Endo Pharmaceuticals Inc.