Not sure how many readers are aaware of this, but a new transdermal is under development. Maybe some of our "professional contacts" have some more updated information on this?
The company's name is "MacroChem" and the product is called "Opterone". It supposeduly uses a new transdermal delivery system (SEPA) to deliver the testosterone through the skin barrier.
I found this link for the company and that specific product:
http://www.macrochem.com/site/content/products/hormone.asp
Some interesting comments off the site:
QUOTE: Opterone is a SEPA-enhanced testosterone cream for the treatment of male hypogonadism. The SEPA in Opterone makes the stratum corneum of the skin more permeable to testosterone, enhancing the delivery of this hormone into the body. In August 2004, MacroChem announced the completion of a pharmacokinetic study of Opterone in hypogonadal males. Opterone delivered testosterone into the bloodstream within the first few hours of application and also provided a more sustained delivery of testosterone over 24 hours compared with our prior gel formulation. In this trial, Opterone was generally well tolerated. Local application site symptoms, when reported, were mild-to-moderate and transient. In December 2004, we initiated a bioavailability study of Opterone, the next step in our development program. END QUOTE
This link discusses the SEPA process:
http://www.macrochem.com/site/content/research/sepa.asp
QUOTE: SEPA is a family of patented compounds that can enhance the transport, penetration and controlled delivery of a wide range of drugs through the skin. "SEPA" is an acronym for "Soft Enhancement of Percutaneous Absorption," where "soft" refers to the reversibility of the skin effect, and "percutaneous" means "through the skin." We have chosen SEPA 0009, a member of the SEPA family, for clinical development. SEPA enhances transdermal drug delivery by temporarily and reversibly disrupting the alignment of the lipid bilayer within the lipid matrix in the stratum corneum. This disruption renders the skin temporarily permeable, allowing a drug to diffuse through the stratum corneum, epidermis and dermis, where it can enter the bloodstream through the capillaries. END QUOTE
Another interesting link:
http://sev.prnewswire.com/medical-pharmaceuticals/20041208/NYW06808122004-1.html
QUOTE: LEXINGTON, Mass., Dec. 8 /PRNewswire-FirstCall/ -- MacroChem Corporation has announced the initiation of the next clinical study in its development program for Opterone(R), its investigational topical cream for male hypogonadism. Opterone combines testosterone with SEPA(R), MacroChem's patented skin-absorption enhancer... 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... "Results from these two studies will allow us to move into a Phase 3 program that we expect to initiate next year," explained Robert J. DeLuccia, president and chief executive officer of MacroChem. END QUOTE
The way these things move along, unfortunately, I would be surprised if we see this hit the market much before mid to late 2006.
The company's name is "MacroChem" and the product is called "Opterone". It supposeduly uses a new transdermal delivery system (SEPA) to deliver the testosterone through the skin barrier.
I found this link for the company and that specific product:
http://www.macrochem.com/site/content/products/hormone.asp
Some interesting comments off the site:
QUOTE: Opterone is a SEPA-enhanced testosterone cream for the treatment of male hypogonadism. The SEPA in Opterone makes the stratum corneum of the skin more permeable to testosterone, enhancing the delivery of this hormone into the body. In August 2004, MacroChem announced the completion of a pharmacokinetic study of Opterone in hypogonadal males. Opterone delivered testosterone into the bloodstream within the first few hours of application and also provided a more sustained delivery of testosterone over 24 hours compared with our prior gel formulation. In this trial, Opterone was generally well tolerated. Local application site symptoms, when reported, were mild-to-moderate and transient. In December 2004, we initiated a bioavailability study of Opterone, the next step in our development program. END QUOTE
This link discusses the SEPA process:
http://www.macrochem.com/site/content/research/sepa.asp
QUOTE: SEPA is a family of patented compounds that can enhance the transport, penetration and controlled delivery of a wide range of drugs through the skin. "SEPA" is an acronym for "Soft Enhancement of Percutaneous Absorption," where "soft" refers to the reversibility of the skin effect, and "percutaneous" means "through the skin." We have chosen SEPA 0009, a member of the SEPA family, for clinical development. SEPA enhances transdermal drug delivery by temporarily and reversibly disrupting the alignment of the lipid bilayer within the lipid matrix in the stratum corneum. This disruption renders the skin temporarily permeable, allowing a drug to diffuse through the stratum corneum, epidermis and dermis, where it can enter the bloodstream through the capillaries. END QUOTE
Another interesting link:
http://sev.prnewswire.com/medical-pharmaceuticals/20041208/NYW06808122004-1.html
QUOTE: LEXINGTON, Mass., Dec. 8 /PRNewswire-FirstCall/ -- MacroChem Corporation has announced the initiation of the next clinical study in its development program for Opterone(R), its investigational topical cream for male hypogonadism. Opterone combines testosterone with SEPA(R), MacroChem's patented skin-absorption enhancer... 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... "Results from these two studies will allow us to move into a Phase 3 program that we expect to initiate next year," explained Robert J. DeLuccia, president and chief executive officer of MacroChem. END QUOTE
The way these things move along, unfortunately, I would be surprised if we see this hit the market much before mid to late 2006.
