Neuropathic Pain: V3381
Summary
V3381 is a novel drug candidate that is being developed as a treatment for neuropathic pain. V3381, originally licensed from Chiesi Farmaceutici (Chiesi), has a dual mechanism of action, that of an NMDA antagonist and an MAO-A inhibitor, which gives it the potential to modulate pain at both central and peripheral sites.
Background
Neuropathic pain is a chronic form of pain related to damage to nerves and their signalling processes, and unlike other forms of pain, is generally poorly responsive to current analgesics, does not diminish over time and can increase in both intensity and area. This type of pain occurs in diabetes, post-herpetic neuralgia (shingles), side effects of chemotherapy, trigeminal (facial) neuralgia, HIV infection, spinal cord injuries and other nerve injuries (eg. amputation).
Espicom Business Intelligence estimated the 2003 global market for drugs approved for neuropathic pain at U.S. $2.5 billion, despite limited response rates and efficacy, tolerance and dependency issues, and other side effects of current therapies.
According to Pain Therapeutics-Drugs, Markets and Companies, October 2005, the worldwide market for pain is estimated at U.S. $50.0 billion for 2005 and is expected to increase to U.S. $75.0 billion by 2010. 2004 pain management prescription sales were estimated by Pharmaceutical Executive to be U.S. $20.6 billion and are expected to increase to U.S. $29.8 billion by 2008.
The pain management market has grown significantly in recent years, driven by increased demand from patients, better physician responsiveness, an aging population, increasing numbers of surgical procedures as well as the availability of new products. It remains one of the most widely researched yet under treated therapeutic areas.
Clinical Studies
V3381 has successfully completed a Phase IIa study in patients suffering from neuropathic pain resulting from long-standing diabetes. Data from the trial indicates that V3381 was generally well tolerated with good preliminary indications of efficacy, and supported progression of the compound into the next phase of development.
The randomised, double-blind, crossover trial was designed to assess safety, pharmacokinetics and preliminary efficacy of repeat dosing of V3381, with efficacy being assessed on a numerical point pain rating scale recorded using daily diaries. The trial was conducted in the U.S. and Canada and included 46 patients.