Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2002-05-08
2004-06-15
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S764000, C424S773000, C424S777000
Reexamination Certificate
active
06749871
ABSTRACT:
THE FIELD OF THE INVENTION
The present invention relates to compositions for treating urogenital and urological disorders. The present invention relates in particular to compositions that are useful in treating symptoms of interstitial cystitis benign prostatic hypertrophy (BPH).
COPYRIGHT NOTICE
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. 37 CFR § 1.71(d).
PRESENT STATE OF THE ART
The likelihood of experiencing urological difficulties increases for both men and women with aging. Approximately 2 million women in the United States suffer from interstitial cystitis, a painful condition with an unknown pathophysiology. The percentage of men that experience urological difficulties is pronounced primarily due to complications related to the prostrate gland.
The symptoms of interstitial cystitis and BPH vary, but the most common symptoms involve changes or problems with urination, such as a hesitant, interrupted, and/or weak stream; urgency and leaking or dribbling; and more frequent urination, especially at night (nocturial). Symptoms of interstitial cystitis also include discomfort or pain in the bladder or pelvic area and scarring or stiffness in the bladder wall. The American Urological Association (hereinafter “AUA”) has developed a questionnaire to evaluate the symptoms of urological disorders as provided in detail in the section below entitled “Examples of the Invention.” This questionnaire focuses on matters such as sensation of not completely emptying the bladder upon urination, urination frequency, intermittent urination, difficulty in postponing urination, weak urinary stream flow characteristics, and difficulty in urinating urgency for night time urination. The sum of the answers is the symptom score. For men, a urological disorder score from 1-7 is mild prostatism; a score from 8-19 is moderate prostatism; and a score from 20-35 is severe prostatism. For women, a urological disorder score from 1-7 is mild interstitial cystitis; a score from 8-19 is moderate interstitial cystitis; and a score from 20-35 is severe interstitial cystitis. See, for example, S. Margolis and H. Ballentine Carter,
Prostate Disorder
, at 13, The Johns Hopkins Medical Institutions (1997).
The causes of interstitial cystitis are currently not well understood. Theories to explain interstitial cystitis include the theory that interstitial cystitis is an autoimmune response following a bladder infection. Another theory is that interstitial cystitis is caused by a bacterial infection which is not detectable in urine tests. Because the cause of interstitial cystitis is unknown, treatment mainly focuses on reducing symptoms. Bladder distension, often done to diagnose IC, can reduce symptoms. A bladder instillation or bladder wash, in which the bladders is filled with a solution held for a period of 10 to 15 minutes, is another common interstitial cystitis treatment. The bladder instillation may also include the drug, dimethyl sulfoxide.
Treatment for interstitial cystitis may include drugs administered orally, and in severe cases, surgery. Drugs such as pentosan polysulfate sodium, antidepressants, and antihistamines have been used to treat interstitial cystitis. Surgical options include fulguration and resection of ulcers, bladder augmentation, and bladder removal. Fulguration is the burning of ulcers with a laser or with electricity. After the area heals, the dead tissue sloughs off, leaving new, healthy tissue. Resection of ulcers involve cutting around and removing ulcers.
Bladder augmentation involves removing damaged portions of the bladder. A portion of the patient's large intestine is then removed and attached to the bladder. After-effects of this surgery may include infection in the bladder and difficulty absorbing nutrients from the intestine. In addition, the symptoms of interstitial cystitis, pain, frequency and urgency, may continue even after surgery.
Another surgical option, bladder removal, requires urine to be rerouted. In a urostomy, a ureter is attached to a piece of bowel that opens onto the skin in the abdomen. Urine is emptied through the opening in the skin and into a bag, either outside the body or inside the abdomen. The area around the opening must be kept clean to avoid infection. Since surgical solutions for interstitial cystitis can have many adverse side effects, surgery is generally an option in only the most severe cases. An improved orally-administered treatment for interstitial cystitis is needed.
Like interstitial cystitis, causes for BPH are unknown. However, BPH may be caused by an enlarged prostate. It is common for the prostate gland to become enlarged as a man ages. As a male matures, the prostate goes through two main periods of growth. The first occurs early in puberty when the prostate doubles in size. At around age 25 the gland begins to grow again. It is this second growth phase that often results, years later, in the condition know as benign prostatic hyperplasia or benign prostatic hypertrophy (hereinafter “BPH”). Statistically, BPH rarely causes symptoms before age 40, but more than half of men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH. As the prostate enlarges, the surrounding capsule stops it from expanding, causing the gland to press against the urethra. The bladder wall becomes thicker and irritable. The bladder begins to contract even when it contains small amounts of urine, causing more frequent urination. As the bladder weakens, it loses the ability to empty itself, and urine remains behind. This narrowing of the urethra and partial emptying of the bladder cause many of the problems associated with BPH.
Men who experience symptoms that cause major inconvenience or health risk usually need some kind of treatment. Most doctors recommend removal of the enlarged part of the prostate as the best long-range solution for patients with BPH. Surgery for BPH removes only the enlarged tissue that is pressing against the urethra. The rest of the prostate is left intact. A common surgery of this type is transurethral resection of the prostate (TURP). With the TURP procedure, an instrument called a resectoscope is inserted through the penis. The resectoscope, which is about 12 inches long and one-half inch in diameter, contains a light, valves for controlling irrigating fluid, and an electrical loop that cuts tissue and seals blood vessels. The pieces of cut tissue are carried by fluid into the bladder and then flushed out at the end of the operation.
Another surgical procedure is called transurethral incision of the prostate (TUIP). Instead of removing tissue, as with the TURP procedure, this procedure widens the urethra by making a few small cuts in the bladder neck and in the prostate gland itself. Other new treatment techniques are also being investigated, such a laser surgery, microwave thermotherapy and prostatic stents. Transurethral procedures are less traumatic than open forms of surgery and usually require a shorter recover period.
Reportedly, the management of benign prostatic hyperplasia is in transition. See, for example, J. E. Oesterling,
Benign Prostatic Hyperplasia, The New England Journal of Medicine
99, Vol. 332(2) (1995). In addition to surgical treatment, non-surgical drug therapies are also being investigated, such as androgen-deprivation therapy and a-adrenergic antagonists. For example, the 5a-reductase inhibitor, Finasteride, in a three-year clinical evaluation showed reduction in prostatic volume by about 27%, improvement in urinary flow rate by 2.3 ml per second, and a reduction in symptom score by 3.6 points. However, about four to five percent of the participants experienced side effects such as decreased libido and impotence. See, J. E. Oesterling and
Lilling Herbert J.
Prater Herbs, L.L.C.
Stoel Rives LLP
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