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Looks like the tren cough (as we know it) has made headlines.
I have been following the approval process of Nebido through Indevus Pharmaceuticals. It was delayed by a reaction to an injection in trials that we know as tren cough. The good news is that Nebido has been refiled with additional data and could be approved in 2010. Good news for HRT patients who prefer the pin over the patch gel or buccal or even the implant.
Read here:
" The Company believes the requirement for additional data relates to a reaction immediately following the injection and is a known rare complication of oil-based depot injections.
The reaction is believed to be the result of a small amount of the oily solution immediately entering the vascular system from the injection site and may be due to improper injection technique.
The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting.
The Company believes that the FDA's safety concern is derived from spontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml)dose. In the Indevus U.S. clinical trials, which included a total of approximately 500 patients, there was a single, non-serious, instance of this phenomenon with the 750 mg (3ml) dosage of NEBIDO.
The patient did not require medical intervention and the event resolved without issue within 10 minutes. This patient has continued to receive regular injections without further incident. Because estimations of the true frequency of these events are difficult to determine from post-marketing reports on patients having received the 1000 mg (4ml) NEBIDO dose, FDA has asked for new data to more precisely calculate the incidence of the occurrence prospectively, as well as methods or procedures to mitigate the incidence with the 750 mg (3ml) dosage.
Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus stated, "We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of NEBIDO given the large European experience. Rare coughing reactions have been well-described in the European product labeling of NEBIDO.
We believe the information available on these cases indicates these reactions resolved without consequences and that our proposed labeling for NEBIDO in the U.S. adequately addressed this issue. We intend to vigorously pursue the approval of NEBIDO and will allocate the resources necessary to conduct an additional study to satisfy the concerns of the FDA. From our verbal discussion with the FDA, we are not aware of any other approvability issues."
http://www.biohealthinvestor.com/2008/06/indevus-and-two-year-delay-on-nebido-idev.html
http://seekingalpha.com/article/80164-indevus-pharmaceuticals-nebido-has-lost-its-libido
I have been following the approval process of Nebido through Indevus Pharmaceuticals. It was delayed by a reaction to an injection in trials that we know as tren cough. The good news is that Nebido has been refiled with additional data and could be approved in 2010. Good news for HRT patients who prefer the pin over the patch gel or buccal or even the implant.
Read here:
" The Company believes the requirement for additional data relates to a reaction immediately following the injection and is a known rare complication of oil-based depot injections.
The reaction is believed to be the result of a small amount of the oily solution immediately entering the vascular system from the injection site and may be due to improper injection technique.
The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting.
The Company believes that the FDA's safety concern is derived from spontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml)dose. In the Indevus U.S. clinical trials, which included a total of approximately 500 patients, there was a single, non-serious, instance of this phenomenon with the 750 mg (3ml) dosage of NEBIDO.
The patient did not require medical intervention and the event resolved without issue within 10 minutes. This patient has continued to receive regular injections without further incident. Because estimations of the true frequency of these events are difficult to determine from post-marketing reports on patients having received the 1000 mg (4ml) NEBIDO dose, FDA has asked for new data to more precisely calculate the incidence of the occurrence prospectively, as well as methods or procedures to mitigate the incidence with the 750 mg (3ml) dosage.
Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus stated, "We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of NEBIDO given the large European experience. Rare coughing reactions have been well-described in the European product labeling of NEBIDO.
We believe the information available on these cases indicates these reactions resolved without consequences and that our proposed labeling for NEBIDO in the U.S. adequately addressed this issue. We intend to vigorously pursue the approval of NEBIDO and will allocate the resources necessary to conduct an additional study to satisfy the concerns of the FDA. From our verbal discussion with the FDA, we are not aware of any other approvability issues."
http://www.biohealthinvestor.com/2008/06/indevus-and-two-year-delay-on-nebido-idev.html
http://seekingalpha.com/article/80164-indevus-pharmaceuticals-nebido-has-lost-its-libido
