Raptor Pharmaceutica (Raptor) has reported positive clinical trial data on NGX426, the company’s orally administered, non-opioid, AMPA/kainate receptor antagonist. The results of the study suggested that NGX426 could be effective in a variety of neuropathic pain states, which are caused by damage to or dysfunction of the peripheral or central nervous system rather than stimulation of pain receptors.
The objective of the single center, double-blind, randomised study was to demonstrate that the orally administered prodrug NGX426, maintains the analgesic effect previously shown for the active moiety, tezampanel.
In the study, a total of 18 study subjects have received single doses of 90mg of NGX426, 150mg of NGX426 or placebo in each of three treatment periods. Pain was induced by injecting 250ug (microgram) of capsaicin under the skin of the forearm at 30 minutes and 120 minutes after dosing.
The 150mg dose showed reductions in spontaneous pain versus placebo after the 30 minute and 120 minute capsaicin injection time points. At the 150mg dose, reductions in elicited pain were also statistically significant versus placebo. The 90mg dose of NGX426 showed statistical difference versus placebo after the 30 minute time point on reduction of spontaneous pain, hyperalgesia and allodynia.
Christopher Starr, CEO of Raptor, said: “We are encouraged by these results suggesting that NGX426 could be effective in the treatment of acute pain such as migraine and chronic pain, such as neuropathy. NGX426 has been administered to 182 male and female healthy subjects in single and multiple doses and all doses of NGX426 were well-tolerated with no serious or medically important adverse events reported.
“We believe the pain indication could benefit from such a safety profile and potential efficacy profile. We plan to continue to explore our options with NGX426 in the treatment of pain, and we are actively looking for partners or collaborators regarding the development of this product candidate.”