MacroChem Phase III programme in 2005

MacroChem from Lexington, MA, US, has initiatied the next clinical study in its development program for Opterone, its investigational topical cream for male hypogonadism.

Opterone combines testosterone with Sepa, MacroChem's patented skin-absorption enhancer. The Sepa in Opterone makes the stratum corneum of the skin more permeable to testosterone, enhancing the delivery of this hormone into the body.

The purpose of this bioavailability study is to compare the rate and extent of absorption of testosterone into the bloodstream following administration of different dose volumes of Opterone to different application areas. The study was initiated at a US clinical site following successful completion of a pharmacokinetic study of Opterone cream in hypogonadal males.

'Results from these two studies will allow us to move into a Phase III program that we expect to initiate next year,' explained Robert DeLuccia, president and chief executive officer of MacroChem.

'Male hypogonadism is a medical condition of increasing importance, and represents a growing market open to new and improved therapies,' DeLuccia said. 'I believe Opterone can make an important contribution to managing this condition.'

About testosterone therapy

Low circulating testosterone is an underdiagnosed medical condition with potential long term health consequences if left untreated. Some men do not produce enough testosterone, resulting in a condition known as hypogonadism. Signs and symptoms of hypogonadism include low sex drive, erectile dysfunction, fatigue, depression, reduced muscle mass and strength, increased body fat and decreased bone mineral density. According to the Endocrine Society, approximately four to five million men in the US may be hypogonadal. Currently, only about 5% are treated. In 2003, US sales of testosterone products for male hypogonadism grew 20% and exceeded half a billion dollars.