The FDA Approves the Drugs for ED Treatment

On the 30th of June, 2000 in Washington. Studies showed that approximately thirty million men in the United States experience erectile dysfunction (ED). Those who are anticipating a new drug instead of Viagra which is available at Canadian Health&Care Mall at affordable prices will have to wait until another drug called Uprima (apomorphine) is approved of to be applied as a way to treat erectile dysfunction. That drug demonstrated that it is a safe alternative for those who have heart disease.

How Uprima was used

Apomorphine stimulates the centers of the brain, which deal with a sexual response as well as activating the vertebral nerves to enhance the blood flow through the erectile tissue. Furthermore, the drug had several uses throughout the history, some of them were:

  • In 1869, Uprima has been used to treat several disorders for more than a century;
  • In the 2nd half of the 20th century, the drug has been used as a sedative;
  • Since 1967, It was used as a therapy for Parkinson’s disease.

For now, many want for Uprima to be used for treating erectile dysfunction and waiting for its approval.

TAP Pharmaceuticals, which is a joint of Abbott Park Laboratories and Japan’s Chemical Industries of Takeda announced the decision about withdrawing the application for Apomorphine in order to finish some ongoing researches about it to ensure the safety of the drug and its efficiency. The FDA agreement was anticipated in July due to a professional advisory committee advice, which led to the voting 9-3 in April to make the agency officials begin the approval process.

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The obstacles that the approval of the drug is facing

UprimaAlthough the FDA committee is supporting the approval of Apomorphine, there has been some serious issues with it including:

  • Using the drug along with nitrates, which are a known drug to treat heart disease, may result in some bad side effects. Although Canadian Health&Care Mall thinks that Viagra may lead to adverse reactions as well when used along with nitrates.
  • Uprima has an obvious reaction with alcohol, and that may lead to a severe low pressure of the blood, fainting and slower heart rate.
  • There were several questions regarding the efficiency of Uprima, particular questions toward the clinical trials, and if their study had men with bad sexual dysfunction or not.

During the clinical trials, over half of the experiment group got an erection among 35% of the patients. This high rate raised questions that some of the men used in the experiment were not suffering a severe dysfunction.

The urologist and director of West Coast Clinical Research in Nyus, Calif is Eugene Dula, MD. He announced that ED is linked to a high placebo response. Consequently, questions about if the right patient population was used in the test or not are unfounded.

What made the FDA committee votes for approving and the result

When the FDA committee was asked about its voting for the support of approving the drug despite the potential risks and side effects, the FDA Committee Chair Ricardo Azziz, MD said to the WebMD that the ED is the main quality of life concern.

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Now professionals are speculating the industry to withdraw the application due to the likelihood that the drug will not meet the committee’s recommendation to be approved of. Either way, Apomorphine’s reaction with alcohol and nitrates need to be seriously considered due to the risks it may cause, which is what Marianne Mann, MD, the deputy director of the FDA said in April assembly.

However, the delay of having a final decision about the drug does not mean that it will not be approved of eventually. Kim Modroy, a speaker for TAP Pharmaceuticals says to WebMD that they are so confident that Apomorphine is effective and safe.

It is crucial for using Apomorphine that the patient gets counseling, and we urge the patients to consult their doctor before using the drug, or any drug for that matter. However, if they want a drug free solution they can check the solutions on our website.