Drug for FDA approval: What to know that could/can help you
As we as a society continue to advance in creating new technologies and medicine, new drugs are always being created to help treat a person/ or group who suffer from a certain condition. Pharmaceuticals drugs are always making new discoveries because of new diseases or conditions that are being discovered due to many cases that are being reported by the people or media. This year already, 12 drugs have been approved by the FDA, but many more are expected to be approved since it’s not even halfway through the year and there are still dozens of drugs left to be approved. One of the upcoming drugs seeking approval is TherapeuticsMD’s Yuvvexy, a drug which purpose is to reduce pain for women during sexual intercourse. Yuvvexy is waiting to be approved on May 7th, 2017 by the FDA. Yuvvexy is a drug that has been developed by TherapeuticsMD for treating women who suffer Vulvar and Vaginal Atrophy (VVA), which creates vaginal pain from sexual intercourse. As women start approaching their mid 40’s many women report that they suffer pain when having sexual intercourse due to the vagina drying, bleeding, or dyspareunia. Over 32 million women in the United States suffer from these symptoms but only 7% of them are prescribed medicine to treat this condition (roughly 2.3 million).
Not only is this considered a huge problem to couples, but this symptom isn’t going away and is actually growing. A major role that plays into this is because of a major spike in sexual activity in the past 10 years and that when women on average live longer than their past ancestors, they spend more time living with reproductive hormones, but aren’t reproducing. TherapeuticsMD specializes in making medicine specifically for women only ever since the company was founded. The company released a statement explaining the Yuvvexy (TX-004HR) just finished phase three or The Rejoice Trial of testing Yuvvexy while comparing it to competitors. The trial consisted of 764 women in areas around the U.S. who took a certain dosage of Yuvvexy depending on what they were given. All women took the dosage once a day for 2 weeks, the twice a week for 10 weeks creating a 12 week experiment. At the end of the Rejoice trial, there wasn’t any health concerns reported from the women and also significant results were shown that improved their conditions. The report also showed that Yuvvexy has proven much better results than the competing drug according to the reports by the test subjects. As investors are looking to invest into TherapeuticsMD, there isn’t a whole lot of doubt in trust in the company. The company’s CEO Robert G. Finizio has over 10 years of experience in health being previous CEO’s in other companies (Vitamed from April 2008 to October 2011 and CareFusion LLC ) “The acceptance of the NDA for Yuvvexy is an important milestone for TherapeuticsMD as we pursue our goal to provide women with novel healthcare solutions that address their needs throughout life,” said TherapeuticsMD CEO Robert G. Finizio.