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Solbec wins ethics approval
23-July-2001
Solbec Pharmaceuticals (SBP) today received the Granting of Ethics approval for the clinical trials in Australian hospitals of its Andromen Forte 5% Cream. Solbec is studying the levels of absorption of the cream, which addresses Androgen deficiency in males.

The study will be undertaken by Professor David Handlesman, Director of the ANZAC Research Institute and Department of Andrology, Concord Hospital, NSW. Solbec expects the study to confirm the Pharmacokinetic profile of Testosterone when delivered transdermally using Lawley Pharmaceuticals Andromen Forte 5% Cream.

Current treatment for Androgen deficiency is either by injection, implants, patches or oral capsules all of which result in either variable absorption profiles or uncomfortable side effects.

Solbec hopes the application of Andromen Forte 5% Cream will overcome the variable absorption profiles and minimise the side effects seen with the currently marketed products.

The study will complete the clinical data package which is required by the TGA for the licensing and sale of Andromen Forte 5% Cream both in Australia and overseas. Solbec expect to lodge the complete licensing data package with the TGA for Lawley's Androfeme (Testosterone 1%) Cream before the end of