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MALVERN, Penn. (
TheStreet) -- Let's discuss crooked penises and the prospects for the FDA approval of a new treatment from
Auxilium Pharmaceuticals(AUXL). Regulators are expected to announce their approval decision on the Auxilium drug, known as Xiaflex, on Sept. 6.
My prediction: FDA rejection, but I'm torn with indecision. My conviction level is 5-6 out of 10 -- so not much more than a toss up. The Xiaflex clinical trial data show the treatment takes some bend out of crooked penises and reduces related symptoms. Results were consistent across two phase III studies. The drug is also already FDA approved for a similar disease that freezes fingers in bent positions.
The overall Xiaflex benefit seen in the two phase III trials, however, is modest and relied on a questionable efficacy endpoint and a modified patient analysis to barely reach statistical significance. Any FDA adjustment could render the studies negative. Laser-beam straight penises? Um... no, not with Xiaflex. Side effects? Yes, some substantial including three cases of "penile rupture." You're not the only guy squirming right now. [Ladies, sympathy, please.] The risk-benefit picture with Xiaflex is murky.
Auxilium shares have lost 3 percent this year and closed Friday at $18.06.
Let's delve deeper into the Xiaflex data.
Crooked penis is a real disease. It's call Peyronie's and is caused by the build up of collagen plaque on one side of the penis. This scar tissue, in turn, causes the penis to bend or curve at an extreme angle. Men with Peyronie's experience pain, embarrassment (naturally) and many have difficult engaging in sex for physical and psychological reasons. Current treatments are relatively ineffective. Surgery is an option for worse cases but outcomes aren't always ideal.
Xiaflex is an enzyme that breaks down the collagen plaques. It's injected directly into the penis. Once the plaque starts to dissolve, manual "modeling" or straightening of the penis is supposed to alleviate the bothersome curvature.
Auxilium conducted two phase III studies of in men with Peyronie's in which Xiaflex injections were compared to sham, placebo injections.