Kenneth Kirby, the president of TransDermal Delivery Solutions Corp., sees his company’s transdermal drug delivery system as transforming the way we think about medication. By avoiding the oral delivery route, Kirby says it can help drugs retain their potency and begin working faster. He likens transdermal drug delivery as a modern day poultice.
Its lead indication is for the treatment of low testosterone in men called Testagen TDS. Earlier this summer, the U.S. Food and Drug Administration approved an IND application for Testagen, paving the way for the company to conduct several clinical trials. It will help evaluate the drug’s ability to surmount a couple of the biggest challenges. One is transference, which is the risk of the low testosterone drug that’s applied to the forearms being inadvertently rubbed off onto a family member. Low testosterone drug treatments pose a special risk to children, and, to a lesser extent, women.
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A comparatively minor challenge is the impact it can have on lifestyles since users usually can’t bathe or get wet for eight hours after applying or face having to reapply the drug. Kirby says it’s surmounted those challenges with ethanol in the spray that dries on the skin’s surface after a few minutes.
The company will do Phase 1 and 2 dosing studies. A Phase 2 study will assess transference, according to a company statement. A Phase 3 comparative analysis test will compare the drug’s response to others on the market over a 90 day period.
In addition to Testagen, Kirby said the company’s interested in other applications such as local anesthesia, Lidocaine. Using its transdermal solution could be a useful way to steer patients away from the addictive properties of opioids as well as their other side effects like constipation. It also has the potential to make medication safer for children and senior citizens, says Kirby.
Although it’s developing a drug that combines estrogen and progesterone to treat pre-menstrual syndrome. It’s also intrigued by progesterone’s potential to treat traumatic brain injuries, as research from Emory seems to indicate. It’s also developing the drug delivery system for use with Diazepam, a sedative that’s also anti-convulsive drug.
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Kirby said it’s seeking funding of $3 million to $7 million to complete work on Progesterone, an Estrogen/Progesterone combination and Diclofenac Sodium. He added that a licensing deal for Testagen could give it the capacity to take several drugs through the clinical development process, including progesterone, Lidocaine and Diclofenac.
Looking at all the drugs that could be repurposed for transdermal delivery, the company estimates the market opportunity in a neighborhood north of $650 billion.