DiagnosticsSwissmedic Grants Debiopharm Marketing Authorisation For Moapar(R), A New Therapeutic Avenue For The Treatment Of Sexual Deviations
Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announced that the Swiss agency for therapeutic products, Swissmedic, has issued a marketing authorisation for Moapar(R) 11.25mg, the first 3-month injectable formulation, prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering from sexual deviations. Developed by Debiopharm, Moapar(R) contains a gonadotropin-releasing hormone (GnRH) agonist analogue.
"We are very pleased that Swissmedic has recognised the potential of treatment of sexual deviations with Moapar(R)," said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. "This is an important signal for us, as we move closer to providing an alternative treatment for this controversial disorder. It"s a small market, but we feel that it"s our duty to make this treatment available to the medical profession."
Debiopharm already received marketing authorisations and signed license agreements for the distribution of Salvacyl(R)/Moapar(R) in nine major European countries, including France, Germany, the United Kingdom, Sweden, Norway, Denmark, Belgium, the Netherlands and Finland. The product was launched earlier this year in Germany and Belgium. Initial contacts with potential distribution partners for the Swiss market have been made.
About Moapar(R)
In the treatment of sexual deviations in men, intra-muscular administration of Moapar(R) every 3 months, in combination with psychotherapy, presents an advantage over daily oral forms or intra-muscular weekly injections required with antiandrogens such as cyproterone acetate (CPA) and medroxyprogesterone acetate (MPA), and there are fewer side effects.
The approval is based on two studies showing that, combined with psychotherapy, regular injections of the active ingredient, triptorelin, over a period of eight months to seven years in male patients with sexual deviations demonstrated a good efficacy and safety profile. Triptorelin decreased serum testosterone to the level of castration in all patients. Concurrent with the decrease in testosterone levels, the treatment reduced deviant sexual behaviours in 35 of 36 patients with severe sexual deviations. In men who interrupted treatment, testosterone levels progressively returned to normal.
About Debiopharm Group
Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales in excess of US$2.6 billion in 2008.
Debiopharm Group