LAUSANNE, Switzerland, July 21 /PRNewswire/ -- 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, today 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.
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 s
|SOURCE Debiopharm Group|
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