TherapeuticsMD Inc. (NYSEMKT:TXMD) has finally announced a regulatory update of its New Drug Application (NDA) for TX-004HR. The new update comes in at a time after the company had availed the investigational applicator-free estradiol vagina softgel capsule. This particular drug has been developed to treat moderate-to-severe vaginal pain during sexual intercourse or dyspareunia. This is a symptom that is associated with the vulvar and vaginal atrophy (VVA) as a result of individual having attained menopause. Two months ago, according to press release by TherapeuticsMD, the company had participated in meeting with other stakeholders and partners as well as the Food and Drug Administration with the main aim being to respond to the letter from FDA concerning issues raised.
The Need to Present Regulatory Updates as Per FDA Policies
Earlier, according to different sources, FDA had raised concerned about the TX-004HR as far as side effects and effectiveness are concerned. With the FDA was said to have been looking for proper presentation of the drug use, limitations and other factors crucial for ensuring that the drugs were safe for human use. Through the meeting with FDA and other stakeholder, the company was expected to address different issues laid down by the FDA in a minutes of a meeting which had taken place earlier.
It is also expected that the company will have a series of talks with the FDA. The meetings will basically be aimed at reviewing information and timelines associated with the manufacturing and distribution of such a drug. According to FDA, the company is tasked with providing additional clarity on the pathway forward for the NDA for TX-004HR in the coming few weeks. With such talks being underway, analysts have expressed their confidence that the company will be in a position to work with FDA while using the formal dispute resolution processed laid down by FDA in case a reasonable timeline to address some issues is not reached.
The Future is Bright for TherapeuticsMD and FDA Relations
With the introduction of such a new drug, the company, according to many sources, will be in a position to acquire a competitive future as far as the need to survive in the health sector is concerned. FDA, however, will be expected to regulate the company’s production to enhance quality drug production.
TherapeuticsMD stocks closed yesterday’s trading session at $5.75 after declining $0.14 or 2.38%.