Showing posts with label IMPORTANT! Passage Of Compounding Safety Bill Positions TherapeuticsMD In Hormone Therapy Market. Show all posts
Showing posts with label IMPORTANT! Passage Of Compounding Safety Bill Positions TherapeuticsMD In Hormone Therapy Market. Show all posts

Wednesday, October 30, 2013

IMPORTANT! Passage Of Compounding Safety Bill Positions TherapeuticsMD In Hormone Therapy Market Oct 30 2013, 13:58 | about: TXMD


Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
We continue to remain positive on TherapeuticsMD Inc. (NYSEMKT:TXMD) shares, a specialty pharmaceuticals company developing advanced-stage pharmaceutical hormone replacement therapy (HRT) products. Shares of TXMD have been on the rise after the House of Representatives passed a compounding safety bill - The Drug Quality and Security Act. While the passage of the bill has surprised many, we had predicted in a previous article that the bill would likely be passed. Although the bill still has to pass through the Senate, its passage in the House is crucial having been seen as a major hurdle. Earlier in the week, the company also announced achievement of significant proof-of-concept in phase 1, first-in-class soft gel vaginal formulation TX12-004HR. In addition, the company also hired a clinical expert. Before discussing what kind of impact these developments could have on TherapeuticsMD, let us just recap what the House bill is in essence about.
Making HRT safer
As we discussed in the previous article, drugs that address a single hormonal issue or monotherapies do not work well in hormone therapy. This is due to the fact that when a drug suppresses one problem hormone, the levels of another problem hormone increase. This issue created a need for developing combination therapies for HRT. Currently, the only drugs for HRT that have been approved by the FDA are monotherapeutic bio-identicals. As a result, doctors have been forced to send women needing HRT to compounding pharmacies that create over-the-counter hormone therapies by compounding non-FDA approved synthetic drugs. These therapies unfortunately have severe side-effects such as cancer.