(Reuters) - Trimel Pharmaceuticals Corp said its experimental drug to treat hypogonadism, or low testosterone levels, in men met the main goal of a late-stage study.
The company said patients who were administered the intranasal drug CompleoTRT for 90 days showed average testosterone levels within the U.S. Food and Drug Administration’s efficacy guidance for a testosterone replacement therapy.
It added that no drug-related serious adverse events were observed.
Trimel, which took over the development of the drug in May 2009, said it is collecting additional nasal safety data from patients administered the drug for up to 360 days as part of its marketing application to the FDA.
The Ontario-based company expects to gather the data by the first quarter of 2013.
Shares of Trimel, which has a market value of about C$177 million, closed at C$1.95 on the Toronto Stock Exchange on Wednesday.
Reporting by Krithika Krishnamurthy in Bangalore; Editing by Roshni Menon