The Swedish national authorities have granted marketing approval for Debiopharm's once-every-three-months Moapar for the reversible reduction of testosterone to castrate serum levels, in order to control sexual drive in adult men.
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The biopharmaceutical company will now apply for wider European approval through the mutual recognition procedure (MRP).
In the treatment of sexual deviations in men, administration of a drug every 3 months is an advantage over daily oral forms or intra-muscular weekly injections required with antiandrogens such as cyproterone acetate (CPA) and medroxyprogesterone acetate (MPA).
Moapar has also shown fewer side-effects compared to antiandrogens (CPA and MPA), including a lower risk of hepatocellular damage, thromboembolism and gynecomastia.
Two studies have shown that monthly injections of triptorelin over a period of eight months to seven years, in young male patients with sexual deviations demonstrated a good safety and efficacy profile.