|
 Patients who were given the drug, Androxal, experienced superiority
in sperm concentration compared with those who used Abbvie Inc's
AndroGel, said the company. The company said the proportion of
subjects responding to Androxal were greater than the proportion
responding to both the approved topical gel and placebo.
The results of the second study have not yet been released.
In July, the U.S. Food and Drug Administration recommended sperm
concentration and responder rates as important parameters for
assessing the drug's approval.
Androxal is being developed as an oral therapy to treat men of
reproductive age with low testosterone.
The company said it believes it can submit an application for FDA
approval by the end of the year.
Other testosterone products in the market for the condition include
Endo International Plc's Aveed, an injection and Trimel
Pharmaceuticals Corp's Natesto, a nasal gel.
(Reporting by Anjali Rao Koppala in Bangalore; Editing by Lisa
Shumaker)
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