The FDA's request for more data on Androxal

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The results offered some hope to the tiny drug developer, whose testosterone drug Androxal was rejected by the U.S. Food and Drug Administration in December, sending its shares into a spiral over the next few months.

The shares continued their climb on Thursday, hitting their highest in five and a half months.

The results offered some hope to the tiny drug developer, whose testosterone drug Androxal was rejected by the U.S. Food and Drug Administration in December, sending its shares into a spiral over the next few months.

Repros is conducting an additional study in response to the FDA's request for more data on Androxal, a drug that aims to treat secondary hypogonadism, a condition that leads to low testosterone levels in men, in combination with diet and exercise.
"We'll know before the beginning of June whether there's a benefit; if not I'm not going to pursue it and we're going to focus all our efforts on Proellex," Chief Executive Joseph Podolski told Reuters.

"That said, I am willing to bet that Androxal is going to show results," he said.

Repros applied for U.S. marketing approval for Androxal in February 2015, based on data from four studies, two of which compared the drug to a leading FDA-approved treatment.
The health regulator tightened its rules on the use of testosterone drugs last year, saying they should be reserved for patients with specific conditions, such as genetic disorders or tumors that impair the function of the testicles.

There is still hope for Androxal in Europe, where regulators had a more positive outlook on it.

With Androxal's future in doubt, the focus has shifted to Proellex, which has shown encouraging results in uterine fibroids and endometriosis, a disease in which tissue that normally grows inside the uterus grows outside it.

The standards of care for uterine fibroids and endometriosis consist of surgery or short-term treatment with hormonal drugs, which cause loss in bone density. They are not recommended for use for more than six months.

Laidlaw Co analyst Yale Jen said the potential sales for the two indications combined could exceed $1 billion.
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Interim data from the single-blind, placebo-controlled study suggested that the use of Androxal did not result in bone loss as compared to placebo. Additionally, data hinted that Androxal may improve bone mineral density.

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