January 07, 2002 - Hairlosshelp.com spoke to a representative of Glaxo SmithKline today to get more information about the impending release of Dutasteride. According to the company representative the delay is because Glaxo are waiting for the approval of the SNDA (Secondary New Drug Application) that was submitted to the FDA in December of 2001. The SNDA contains the 2-year follow up data of the initial clinical trials. Glaxo received approval based on the 1 year data but are limited by what they can put in their marketing materials about the drug. The approval of the second year data will give them more room to make more claims about their product.

According to the spokesperson they have not yet made a firm decision whether they are going to wait on approval of the SNDA at this time. It could take up to 180 days for the FDA to approve the SNDA. Glaxo still plans on presenting their 1-year data at the European Association of Urology meeting in February 2002.

Hairlosshelp.com was able to obtain the data in advance and is presenting excerpts of it. One of the major concerns has been the dose that was used and the side effects. The dosage used in the studies was 0.5mg. At this daily dosage Dutasteride reduces serum DHT levels by 85% in the first week, and 90% by the second week. The peak serum levels of Dutasteride occur within 2 to 3 hours. The effect on DHT is dose dependent and the half-life is approximately 5 weeks.

Dutasteride will be in a soft gel capsule form that is yellow in color with red print. Glaxo has not yet announced the brand name although it is believed to be Duagen which has been trademarked by Glaxo and they have also registered the web site domain Duagen.com.

More information will be updated soon.