Innovations in Chronic Pain Therapeutics
Testosterone therapy, fibromyalgia and chronic pain all have been hot topics of discussion in medicine and the lay press because issues remain that have not been addressed in a satisfactory way. What is most often missing in the clinic is an appropriate functional diagnosis of clinical testosterone deficiency based on both clinical symptoms and serum testosterone levels, and treatment paradigms that are both safe and effective.
White Mountain Pharma’s approach is to develop safe and effective treatments for individuals in need, with chronic unresolvable pain, and to demonstrate our unique testosterone gel formulation can dampen pain in these individuals.
We have the team and unique expertise in this space to develop a delivery technology that uses an appropriately formulated testosterone gel that allows for improved outcomes. In a pre-IND meeting, the FDA confirmed and endorsed White Mountain Pharma’s Phase II protocol and plan for continued clinical development of this therapeutic. Our patent portfolio supports this approach.
Based on our pilot clinical studies, White Mountain Pharma’s technology is predicted to deliver testosterone to people with significant need without the well known side effects of opioids, anti-depressants, NSAIDS or benzodiazepines, all of which have been prescribed for fibromyalgia. Current pain therapeutics are also problematic: NSAIDS used chronically can cause significant GI irritation; opioids can cause hyperalgesia, addiction, androgen deficiency and a lack of efficacy or “tolerance” develops over time; and anti-depressants can have significant side effects including sexual dysfunction and decreased libido.
The following articles are examples of how the lay press has written about the benefit/risk profile for testosterone replacement therapy and current chronic pain therapeutics. Such questions of benefit/risk, and efficacy/safety, raised by patients, clinicians and the FDA are important to address. A primary goal of White Mountain Pharma is to develop therapeutics that significantly improve the benefit/risk and efficacy/safety profiles for chronic pain patients. To do this, an improved understanding of the underlying and novel mechanisms of chronic pain, such as those being tested by White Mountain Pharma, is needed.
In Men’s Fight Against Aging, How Much Risk to Take? Wall Street Journal article by M. Beck. October 27, 2014 on the risks of testosterone therapy in men.
FDA Panel Backs Limits on Testosterone Drugs. New York Times article by S. Tavernise. September 17, 2014
I Don’t Feel Your Pain: Men and Women Appear to Suffer Pain Differently. So Do Blacks and Whites. Modern Medicine Has Trouble Even Talking About It. Boston Globe, R. Graham. June 15, 2014
Hamburg: Focus on Chronic Illness Drugs Needed. MedPage Today, D. Pittman. April 11, 2014
Overselling Testosterone, Dangerously. Overselling testosterone to men without proper clinical assessment can be dangerous. New York Times Editorial Board. February 4, 2014
Weighing Testosterone’s Benefits and Risks. The FDA is reassessing the safety of testosterone. New York Times, R.C. Rabin. February 3, 2014
Why Women Are Living in the Discomfort Zone: More Than 100 Million American Adults Live with Chronic Pain—Most of Them Women. What Will It Take To Bring Them Relief? Wall Street Journal, J. Foreman. January 31, 2014
FDA Probes Risks of Testosterone-Boosting Drugs. The FDA is investigating the possible increased risks in men who are taking testosterone-boosting drugs. Wall Street Journal, T.M. Burton. January 31, 2014