The Food and Drug Administration (FDA) has announced that it will require additional testing and data for an experimental testosterone drug, QuickShot Testosterone.
According to Reuters, the FDA made the request to Antares Pharma, Inc., the pharmaceutical company responsible for the drug. QuickShot Testosterone, or QST, is unique in that it is the only self-administered subcutaneous medication for testosterone deficiency that has made it to late-stage trials. Unlike other approved drugs for low testosterone (which is commonly referred to as “Low T”), QST is subcutaneous, meaning it is administered just under the skin, usually in an apparatus such as a patch. This puts QST at an advantage over other Low-T drugs, most of which must be administered intravenously (i.e. with a needle) by a doctor.
Testosterone deficiency is a leading medical condition affecting American men. It is estimated that nearly 13 million men in the U.S. suffer from Low T. Low T is sometimes hard to diagnose, considering that not all affected men exhibit symptoms, and even those who do will sometimes ignore the symptoms or simply write them off as signs of “aging.”
Although ignoring or dismissing these symptoms is understandable, it is also unwise. On average, testosterone levels peak at age 30 and decrease each year by one to two percent. Because the male body naturally decreases testosterone levels by middle age, some men consider symptoms of Low T to be perfectly normal.
However, Low T is a serious medical condition that needs active treatment. Low T can be caused by a variety of conditions, such as Type 2 diabetes, bacterial or viral infection, liver and kidney disease, obesity, cancer (especially testicular cancer), and genetics. If left untreated, Low T can lead to high blood pressure, depression, obesity, sexual problems, and other unhealthy conditions.
Low T is often treated with hormone replacement therapy, using drugs such as QST. Although this treatment is highly effective, studies have shown that natural alternatives, including regular exercise and changes to the diet, can encourage your body to produce more testosterone.
QST raised concern with the FDA when one of the trial patients suffered an allergic reaction, causing him to develop severe hives and rashes. In addition, the FDA wanted a larger testing group and tighter regulation on measuring data.
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