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will enroll about 150 to 200 migraine patients, including those with and without the “aura.” Those patients will have to wait until their pain starts to take the NeurAxon drug, or a standard “triptan.” The goal will be to see whether the experimental drug is better at causing pain relief after two hours, and whether it’s sustained for a full 24 hours.
The second trial will enroll 30 to 40 migraine patients with “aura,” and will give them the drug the instant that visual cue shows up, to see whether it can prevent them from feeling migraine pain. The next time patients have an “aura” come on, they will be given a placebo to see just how much better the drug really is.
A third trial is for a pain condition you don’t hear nearly as much about—painful bladder syndrome (aka interstitial cystitis). Interestingly, NeurAxon is bullish about this study because its compound has been designed to last 24 hours in the body before it is excreted entirely through urine. That means the pain drug naturally funnels through the bladder, which happens to be a problematic, painful organ for about 1.3 million people in the U.S., mostly women—so it’s possible the drug will represent a new, more direct way to treat this condition. This trial will also have about 150 to 200 patients, Bloch says.
This game plan all sounds really expensive, and NeurAxon is doing all of it without a partner. Apparently, the company has stretched its cash reserves a long way. NeurAxon should have enough money until August 2010, and hopes to have positive clinical trial results in hand before then, in the first quarter of 2010, Bloch says. Once the proof of effectiveness in clinical trials is established, then it will be time to cut a deal with a Big Pharma company to take it the rest of the way through the pivotal clinical trials needed to pass muster with the FDA, he says.
If NeurAxon can reach its goals, one of the very first customers will be its chief medical officer, Robert Medve, a chronic migraine sufferer himself. There are almost too many scenarios to sketch out at this point, but if NeurAxon can show that its drug has even a similar effectiveness profile to what’s already on the market, yet lasts longer and avoids the heart affects, it will be a winner, Bloch says. “Our chief medical officer would raise his hand and say ‘I want that drug,'” Bloch says.