Xiapex treatment in Italy: who to contact

Riasunto

• Xiapex in Italy: what is this drug and how it is used in Italy
• Cos’e lo Xiapex
• How the treatment is carried out
• Success rate and side effects
• It is true that Xiapex is no longer marketed in Italy
• You also want to know more about Xiapex drug
• The consequences of the withdrawal of the drug
• What are the alternatives
• Uro-Andrologist Dr. Francesco De Luca: professionalism by your side
  • Choose the professionalism of Dr. Francesco De Luca for information on the Xiapex drug

Xiapex in Italy: what is this drug and how it is used in Italy
Induratio Penis Plastica (IPP), or Peyronie’s disease, is a disease that has a devastating effect on patients and their partners. Several non-surgical therapies have been tried for its treatment, but their effectiveness has remained questionable as well-designed, placebo-controlled studies failed to confirm favorable results. The case of the use of the Xiapex drug in Italy and in the world is different. What is Xiapex
To date Xiapex (clostridium histolyticum collagenase)and the only non-surgical treatment that has been approved by the scientific community to cure Peyronie’s disease, as its safety and efficacy have been proven in several well-organized clinical trials. Xiapex collagenase is a drug manufactured by Sobi, used for the treatment of Peyronie’s disease . In subjects affected by this pathology, the deposition of collagen, which is a substance produced by the body in the course of reparative processes, causes scarring fibrosis and the formation of a plaque of the tunica albuginea of ​​the penis , which in turn cause a curvature of the penis. male genital organ being erect. Xiapexborn as a purified combination of two enzymes of bacterial origin capable of degrading collagen, called collagenase .
According to statistics, this drug has a significant impact on plaques resulting in a reduction in penile curvature by an average of 35%. But the results vary from patient to patient: while some have noticed a slight improvement, others have even managed to solve the problem. How to treat
A course of Xiapex therapy for Peyronie’s disease consists of 3 injections to be givenat least 4-6 weeks apart from each other. The doctor proceeds to inject the medicine into the plaque with or without local anesthesia according to the candidate’s needs. The patient will then perform modeling and stretching exercises between injections.
The number of injections is decided by the andrologist after evaluating the probabilities of success, but after a couple of injections it is possible to understand if the Xiapex will be effective and to what extent. However, it is impossible to wait for further improvement after 8 injections.
The injections that are made directly into the plaque cause the enzymatic cleavage resulting in its reduction: this attenuates the curvature and the discomfort associated with Peyronie’s disease. The action of Xiapex and collagenase allows this pathology to be effectively treated right away, as soon as it occurs. Success rate and side effects
In patients treated with Xiapex in Italy there was an average reduction in the curvature of the male organ in a percentage between 37.6% and 30.5% and the positive results obtained following the treatment are permanent.
Side effects, such as bruising, swelling or pain, are mild and can occur in the treated area after the injection and disappear within a few days. It is good to know that not all doctors are licensedto carry out a collagenase treatment because to use this drug it is necessary to have received specific training. It is true that the Xiapex in Italy is no longer marketed
In the months of September and October 2019 a difficulty in finding the Xiapex was highlighted. The reason is soon said and nothing to do with the effectiveness of the Xiapex for La Peyronie .
Xiapex is a proprietary product of Endo Pharmaceuticals , marketed in the EU and other European and Middle Eastern countries by Sobi . Endo and Sobi have agreed to terminate the cooperation agreement for Xiapex as of December 31, 2019. This decision, however, is not based on safety or efficacy concerns of the drug.
Endo, after first stopping the marketing of Xiapex in Australia and Asia, planned to do the same in Europe by the end of 2019. On November 14, 2019, Sobi applied to the European Commission to withdraw the authorization to enter I trade the medicine “ Clostridium histolyticum Xiapex-Collagenase ”. The marketing of the medicine in Europe, authorized since February 28, 2011, was therefore revoked based on the request of the holder starting from March 1, 2020.
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Le conseguenze del ritiro del farmaco
Il ritiro dello Xiapex dall’Italiaremoved a first-line treatment option for Induratio Penis Plastica from the uro-andrologist’s armamentarium . The reasons seem to respond solely to economic reasons, provided that no additional serious adverse event has been reported that we are not aware of and that there has been no European Medicines Agency concern about its use in IPP.
The consequences of withdrawing the drug are different:

• the work done by researchers who presented Xiapex as a necessary and revolutionary treatment is questioned;
• the problem arises of patients who have already started a cycle, which can no longer be completed;
• there are other patients who had already agreed with their doctors to start treatment with Xiapex, as it is more suitable for their condition, and are now denied them.

What are the alternatives?
At the moment there is no product available to replace the Xiapex treatment in Italy and it is not possible to estimate the number of patients on therapy according to a classic or modified protocol who will be forced to stop treatment. One wonders, rightly, if all this is ethical.
Once the efficacy of Xiapex in Induratio Penis Plastica has been tested, it is our opinion that restarting to offer patients surgery as the only and best treatment represents a step backwards for both patients and doctors. It would therefore be necessary to identify new and valid alternatives.
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