TorreyPines initiates early trial of severe pain drug

The phase I trial with NGX424 will enroll approximately 90 healthy male volunteers at one center in the US, and will evaluate the local and systemic tolerability, safety and pharmacokinetics of the drug, as well as the maximum tolerated dose of a subcutaneous formulation.

“We believe NGX424, and its follow-on compound NGX426, an oral prodrug, may effectively relieve severe and persistent pain through a novel mechanism, without having a negative impact on the cardiovascular system or imparting side effects and risks that may be associated with prolonged use of some pain relief medications,” said Dr Neil Kurtz, CEO at TorreyPines.

In previously conducted placebo-controlled, phase II, proof of concept trials, an intravenous formulation of NGX424 achieved positive data in five pain models. In a placebo and active-controlled trial in migraine, NGX424, administered intravenously, achieved statistical significance in all primary and secondary endpoints traditionally required for regulatory approval. These included pain relief at two hours, pain-free at two hours, sustained pain-free state at 24 hours and relief of nausea, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).

TorreyPines licensed NGX424 and its oral prodrug NGX426 from Eli Lilly & Co in 2003. In addition to a subcutaneous route of administration, the company intends to continue development of the intravenous formulation, as well as develop intrathecal and epidural formulations. These multiple dosing forms permit development across a range of indications including severe migraine, epilepsy, neuropathic pain, spinal cord injury and other intractable pain states.