FDA approves new pill for HIV treatmentAccording to the U.S. Centers for Disease Control and Prevention, there were more than 1 million Americans living with a diagnosis of the HIV infection in the country in 2008, and that figure has continued to grow in the following years.

During 2009 there was an estimated 42,959 new diagnoses of the HIV infection in the country, calling for action to be taken against the deadly virus that attacks the immune system. Considering a significantly large number of Americans are affected by HIV, the U.S. Food and Drug Administration recently approved a drug that will treat HIV-1 infection in adults who have never been treated for the illness.

The drug is called Stribild and is required to be taken once a day by HIV patients to treat the virus.The pill contains two drugs that were previously approved by the FDA and two new drugs called elvitegravir and cobicistat. The older drugs are emtricitabine and tenofovir disoproxil fumarate.

Elvitegravir is a drug that interferes with an enzyme that the virus needs to multiply, slowing down the process in some users. Cobicistat is a pharmacokinetic enhancer that allows an enzyme that metabolizes certain HIV drugs and is used to make the effects of elvitegravir last longer.

“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “New combination HIV drugs like Stribild help simplify treatment regimens.”

The approval of Stribild by the FDA is just the latest action that was taken by the organization to combat HIV. The FDA also approved the first over-the-counter rapid HIV test that can be used at home. The FDA also approved use of the first drug of pre-exposure prophlaxis in combination with safer sex practices.

According to research, 1,408 adult patients were evaluated when taking Stribild for safety and effectiveness. The patients tested were not previously treated for HIV, but were evaluated in a double-blind clinical trial. Participants of the study were separated into two groups. One of the groups was assigned Stribild to take every day and the other group was required to take Atripla, an HIV drug that contains Truvada and efavirenz.

The results of the study showed that between 88 percent and 90 percent of patients treated with Stribild had an undetectable amount of HIV in their blood compared to 84 percent who were treated with Atripla and 87 percent who were treated with Truvada.

FDA approves pain relieving drug
The FDA also recently approved wider use of the painkiller Nucynta ER, which is used to treat the pain associated with (edited for clarification) nerve damage brought on by diabetes.

"Pain from DPN can be difficult to manage, leaving some patients and healthcare professionals looking for alternative treatments," said Keith Candiotti, professor of Anesthesiology and Internal Medicine at the University of Miami School of Medicine. "NUCYNTA ER is a different option than currently approved medications for the management of painful DPN and may be an important new choice for these patients."

A note came in from this manufacturer with further clarification:
" We wanted to clarify that the FDA approved Janssen’s NUCYNTA® ER for the management of pain from diabetic peripheral neuropathy. 
Below is  link to the press release http://www.multivu.com/mnr/57705-nucynta-er-diabetic-peripheral-neuropathy-tapentadol which provides some additional information." 

The expanded approval for the FDA gives Janssen Pharmaceuticals a chance to market the drug for diabetic peripheral neuropathy, which affects almost 8 million Americans and can cause stinging or burning sensations, pain, numbness or weakness in the hands and feet. The supply chain of Janssen Pharmaceuticals might be busier soon with the large number of Americans that the company's new drug could help.
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  1. Please note, a representative of this company contacted us and will be providing a correction to this article shortly.