MacroChem Reports Positive Results for Opterone Topical Testosterone Cream

MacroChem has announced positive results of a bioavailability study of Opterone, its investigational topical cream for treatment of male hypogonadism.

Opterone combines 1 percent testosterone with MacroChem's patented drug-absorption enhancer, SEPA, in a proprietary cream formulation. According to MacroChem, the results of this randomized, crossover, single-dose trial in three treatment groups showed that a single 2.5-g dose of Opterone (25 mg testosterone), applied to the upper arms and shoulders, raised the averaged circulating testosterone levels of all patients into the physiologic range over a 24-hour period. A 2.5 gram Opterone dose contains half the testosterone in half the volume of the starting dose of the marketed gels.

The study results also showed the average maximum circulating total testosterone level in this 2.5-g treatment group was 577 ng/dL, and ranged from 408 to 577 ng/dL across all three treatment groups. Normal circulating total testosterone levels typically range from 300 to 1000 ng/dL. Opterone was well tolerated in this trial. All reported adverse events were mild, with the most common being headache and mild application site reaction.