The disclosure herein relates to drugs, drug delivery devices, and methods for treating pain conditions, and in particular pelvic pain, in women and men
Pelvic pain has long been a problem among women and men. Conventional medicine has treated pelvic pain in various ways including, 1) an organ-specific focus in which pelvic pain is believed to be a symptom of inflammation in the bladder, inflammation or infection in the prostate gland, or pathology of the uterus; 2) focus on the idea of the pudendal nerve being entrapped and needing release; 3) focus on an autoimmune process; or 4) focus supposed on psychiatric problems, a propensity toward malingering, or neurotic somatization.
The approaches described above are based on a misunderstanding of the nature of most cases of pelvic pain. In recent years, evidence has emerged that a large majority of pelvic pain in men and women is related to the presence of trigger points and myofascial dysfunction and trigger point related myofascial pain. Understanding cases of pelvic pain as muscle related pain is an entirely new paradigm in urology. This new understanding sees anxiety and sometimes injury producing trigger points within muscles either at the surface of the muscle, inside the muscle, in the belly or the attachment of the muscle of the pelvic floor. These trigger points are painful bands in muscle that can refer pain to remote sites, and when pressed skillfully recreate a patient's symptoms. When pressed in a specific way these trigger points can release, often attended by a significant reduction or abatement in pain and dysfunction. Pelvic floor trigger points and related myofascial restriction have typically been found to be strongly exacerbated by muscle overuse, local ischemia, psychological anxiety and other perpetuating factors. Trigger point release, particularly for trigger points located on the outside of the body has become a subspecialty within medicine. The inventor of the present invention, David Wise, Ph.D., along with his colleague and co-author Rodney Anderson, M.D., professor of urology at Stanford University, previously described techniques for identifying and releasing trigger points in their book A Headache in the Pelvis: A New Understanding and Treatment for Prostatitis and Chronic Pelvic Pain Syndromes, which was originally published by the National Center for Pelvic Pain Research in 2003, and is incorporated herein by reference in its entirety. He is an author of four other peer-reviewed articles on this subject.
Topical nifedipine has been reported for use in anal fissure and vulvodynia. See e.g., Bornstein, J. et al., J. Pain 2010 11(12): 1403-1409. A clinical trial also is ongoing for the use of vaginal nifedipine as an adjunct to conventionally delivered pelvic floor physical therapy for levator myalgia and pelvic pain. See Clinical Trial No. NCT01586286 (Vanderbilt Univ.) at clinicaltrials.gov. However, these studies neither describe nor suggest the specific application of calcium channel blockers or L-arginine to specific muscle trigger points; or the use of the compounds as disclosed herein.
In an age where there is an epidemic of the use of narcotic medication to treat pelvic pain, there exists an ongoing need for more efficacious treatments for the pain conditions described above. This invention is directed to these, as well as other, important ends.