ZOLADEX LAUNCHED FOR ENDOMETRIOSIS

In the USA, Zeneca Pharmaceuticals' Zoladex (goserelin acetate) has been launched for the treatment of a new indication, endometriosis, following approval of a supplemental New Drug Application in February. The gonadotropin-releasing hormone agonist product is now available for endometriosis in a 3.6mg once-monthly implantable formulation. It has been marketed for advanced prostate cancer in the USA since 1990.

At a press conference to publicize the launch, John Rock of Emory University described an open-label multicenter study comparing the efficacy and safety of 24 weeks of treatment with either Zoladex or danazol (the current standard treatment for endometriosis) in over 200 patients. Improvements in outcome, measured using the American Fertility Society scoring system, were achieved if a reduction in AFS scores of 50% or more was noted. There was a 53% mean reduction in AFS scores for patients in the Zoladex group compared to 33% for patients in the danazol group. This difference was not statistically significant.

Danazol was less well-tolerated than Zoladex. Side effects seen with the Zeneca drug included hot flushes, vaginal dryness, headache and increased libido, while danazol patients reported higher incidences of androgenic effects, such as acne, oily skin and hair, weight gain and hirsutism.