For the treatment of pain
In 1998, DOV licensed bicifadine from Wyeth-Ayerst. Bicifadine is our product candidate for the treatment of pain.
Bicifadine is a chemically distinct molecule with a unique profile of pharmacological activity. It has two primary biochemical actions. It interferes with the ability of glutamate to stimulate calcium entry into neurons by binding to one of its receptors on the neurons surface. In addition, it enhances and prolongs the actions of norepinephrine and serotonin by inhibiting the transport proteins that terminate their physiological actions. Preclinical studies and clinical trials indicate that any of these individual actions or a combination of these actions may account for the analgesic properties of bicifadine.
Bicifadine is not a narcotic and in preclinical studies it has been shown not to act at any opiate receptor. In animal models, bicifadine did not demonstrate abuse, addiction or dependence potential. There have been four Phase I clinical trials and 14 Phase II clinical trials involving over 1,000 patients conducted by Wyeth-Ayerst or us with an immediate release formulation of bicifadine. In five double-blind, placebo-controlled Phase II clinical trials, bicifadine demonstrated a statistically significant reduction in pain, in some cases comparable to or better than positive controls such as codeine.
Recently, we completed enrollment of a Phase II clinical trial in the United States studying our new controlled release formulation of bicifadine. This 750-patient double-blind, placebo-controlled study will compare bicifadine and codeine to placebo in a severe dental pain model.
