EpiCept is pursuing a new, novel approach in the treatment of acute and chronic pain.

Until recently, analgesics to treat these conditions have typically been delivered systemically and absorbed into the bloodstream, with the delivery mechanism either occurring orally, via injection or through a transdermal patch. This systemic delivery is designed to block the perception of pain with the brain rather than at the source of the pain itself.

Despite their wide-spread use, the limitations of current systemically-delivered analgesics are well documented and the potential side effects associated with their use are significant.

For systemically-delivered opioids, risk factors can include:

• Respiratory distress, nausea, vomiting, dizziness, sedation, constipation, urinary retention and severe itching.
• The need for increased dosing and potential addiction after continued use.
• Potential harmful interactions with other drugs.
• Physicians prescribing less than adequate doses due to concerns about addiction and abuse.

Risks and side effects for systemically-delivered non-steroidal anti-inflammatory drugs (“NSAID”s) and adjuvant therapies potentially can include:

• Kidney failure, liver dysfunction, coagulation disorder, gastric ulcers and nausea.
• Hospitalizations and death: There are approximately 16,500 NSAID-related deaths each year and over 103,000 patients are hospitalized annually from NSAID complications.
• Physicians prescribing less than adequate doses to relieve pain due to concern risk of adverse side effects may lead doctors to prescribe treatments less often and at lower doses than may be needed to alleviate pain.
• Potential harmful interactions with other drugs.
• Patients taking lower doses and choosing to suffer with pain than risk adverse side effects.

EpiCept’s Approach

EpiCept is seeking to advance the treatment of acute and chronic pain by pursuing the use of topical analgesics that do not contain the liabilities and side effects inherent to systemic circulation.

While systemic delivery of analgesics primarily blocks the perception of pain within the brain, EpiCept’s product candidates focus on delivering analgesics directly to the pain message, blocking the transmission of pain at its source.

The Company’s product candidates target moderate-to-severe pain that is influenced, or mediated, by peripheral nerve receptors located just beneath the surface of the skin. Studies have indicated that these peripheral nerve receptors play an important role in both the sensory perception of pain as well as the transmission of pain impulses to the brain.

Because topical analgesics are administered directly at the point where the pain signal originates, drug concentrations are localized, resulting in dramatically lower systemic blood levels.

As a result, EpiCept believes that the topical administration of well-known analgesics can provide patients with significant pain relief, while bringing about fewer adverse side effects, fewer drug to drug interactions and lower potential for abuse.