Antares Pharma Incorporated saw dramatic falls in its stock price after hitting a roadblock in clinical trials of its prescription testosterone product. A patient developed an allergic reaction to the drug during the trial, causing the U.S. Food and Drug Administration (FDA) to request additional safety information. A Reuters’ article discusses the setback for the testosterone therapy manufacturer.
Concerns over the safety of prescription testosterone products have been on the rise. Testosterone therapies, like Androgel and Testim, have been associated with an increased risk of heart attacks, strokes, and blood clots. Testosterone lawsuits are being filed across the country on behalf of users experiencing one of these dangerous testosterone side effects.
Yet use of prescription testosterone therapy drugs has been on the rise in recent years. It has become a popular method of treatment for men who have low levels of testosterone. However, some studies have shown that it is often prescribed unnecessarily for men showing normal signs of aging.
Last year it was found that more than a fifth of those prescribed the drugs did not undergo testosterone tests before treatment. Antares’ drug QuickShot Testosterone will now be required to provide additional safety data following the allergic reaction.
During the study, it was found that one of the patients developed hives which lead to itchy, red bumps covering the skin. The manufacturer does not believe that this setback will lead to a major delay because the additional studies required by the FDA could be completed within the next year. According to the Reuters article, the company will need to test 70 more patients with its experimental drug over a six-month period.
The testosterone therapy that is provided by this drug is novel in that it is applied subcutaneously and self-administered rather than being injectable and intramuscular like other products on the market. This would alleviate the need for a doctor to administer every treatment.
If you or a loved one had a heart attack, stroke or other serious injury while using prescription testosterone therapy, you may be entitled to financial compensation. Contact a testosterone lawyer at Lopez McHugh to discuss your legal options. Our experienced testosterone lawyers are available for a free and confidential testosterone case consultation.