The topical testosterone roll-on solution Axiron will no longer be available in Australia, after a licensing deal between its manufacturer and sole distributor was axed.
In a letter to doctors, distributor Eli Lilly advises pharmacies will no longer be able to order the testosterone replacement therapy after December 4, when its licensing agreement with Melbourne-based pharmaceutical company Acrux will be terminated.
Acrux had exclusively granted the license to Eli Lilly and has “no immediate plans to commercialise Axiron in Australia moving forward,” said Eli Lilly general manager Margaret Driscoll in the letter dated 3 November.
While the move has been described by one industry player as significant, Endocrine Society of Australia president Associate Professor Warwick Inder believes it will have minimal impact on patients who can access other testosterone replacement products.
Professor Inder said the major benefit of Axiron was its mode of delivery – the product is applied under the armpit like a deodorant.
“The advantage is it’s more difficult for it to spread through contact to another person, compared to a transdermal cream that’s applied to the arm or the abdomen”.
Alternatives on the market include 1% transdermal testosterone gel called Testogel and an injectable testosterone product given once every three months, he said.
The maker of Testogel, Besins Healthcare, said Axiron’s exit from the market will leave a hole and has warned it may experience short-term stock shortages as a result.
The company’s Australian managing director Geoff Blundell claims the withdrawal of the product “is significant for doctors and the 2,500 men estimated to be using this therapy”.
The company has written to doctors offering advice on how to transition patients from Axiron to its Testogel sachets or Testogel metered dose pump pack.
“We are working to upscale production, but may face short-term supply issues for Testogel sachets. We do however have ample supply of the Testogel metered dose pump pack.
“While the sachet and metered dose pump presentations of Testogel provide the same dose range, scripts are not interchangeable on the PBS and a new Authority script is required to switch Testogel presentations.”